Trial Outcomes & Findings for Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms (NCT NCT02641912)

NCT ID: NCT02641912

Last Updated: 2017-07-11

Results Overview

Participants answered question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

120 mins post treatment on Day 8

Results posted on

2017-07-11

Participant Flow

Participants were recruited at one center in United States of America.

A total of 104 participants were screened. Out of which 100 participants were randomized and stratified based on confirmed Sjögren's syndrome status (Yes\[Y\]/No\[N\]).

Participant milestones

Participant milestones
Measure	Experimental Mouthwash During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Overall Study STARTED	53	47
Overall Study COMPLETED	53	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.	Total n=100 Participants Total of all reporting groups
Age, Continuous	50.66 Years STANDARD_DEVIATION 14.418 • n=5 Participants	51.57 Years STANDARD_DEVIATION 14.111 • n=7 Participants	51.09 Years STANDARD_DEVIATION 14.210 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 120 mins post treatment on Day 8

Population: Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=52 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=37 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8	2.50 score on a scale Standard Deviation 1.057	1.89 score on a scale Standard Deviation 1.149

SECONDARY outcome

Timeframe: 30 mins post treatment on Day 8

Population: ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.

Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=39 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8	2.92 score on a scale Standard Deviation 1.053	2.26 score on a scale Standard Deviation 1.163

SECONDARY outcome

Timeframe: 60 and 240 mins post treatment on Day 8

Population: Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.

Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8 At 60 min. (n= 52, 38)	2.71 score on a scale Standard Deviation 1.091	1.97 score on a scale Standard Deviation 1.197
Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8 At 240 min. (n=53, 35)	2.42 score on a scale Standard Deviation 1.151	1.77 score on a scale Standard Deviation 1.087

SECONDARY outcome

Timeframe: 5 mins post treatment on Day 8

Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8 Having a Immediate Dry Mouth Relief(n=53, 42)	3.57 score on a scale Standard Deviation 1.169	3.02 score on a scale Standard Deviation 1.297
Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8 Having a Immediate Lubricating Effect(n=53,43)	3.58 score on a scale Standard Deviation 1.247	2.67 score on a scale Standard Deviation 1.304
Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8 Having a Immediate Moisturizing Effect(n=53,43)	3.55 score on a scale Standard Deviation 1.234	2.93 score on a scale Standard Deviation 1.183

SECONDARY outcome

Timeframe: 30 mins post treatment on Day 8

Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q2: Feeling Comfortable in The Mouth(n=53,39)	3.00 score on a scale Standard Deviation 1.019	2.28 score on a scale Standard Deviation 1.169
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q3: Soothing Your Mouth(n=53,38)	3.02 score on a scale Standard Deviation 1.065	2.34 score on a scale Standard Deviation 1.169
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q4:Allowing to Speak Without Difficulty(n=46,34)	3.11 score on a scale Standard Deviation 1.059	2.59 score on a scale Standard Deviation 1.184
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q5: Effectively Moistens Your Mouth(n= 53,39)	3.02 score on a scale Standard Deviation 1.101	2.33 score on a scale Standard Deviation 1.177
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q6: Effectively Lubricates Your Mouth(53,38)	3.04 score on a scale Standard Deviation 1.091	2.24 score on a scale Standard Deviation 1.173
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q7: Helping to Freshen Your Breath(n=52,34)	3.06 score on a scale Standard Deviation 1.162	2.18 score on a scale Standard Deviation 1.336
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q8: Protecting Your Mouth From Drying Out(53,38)	2.98 score on a scale Standard Deviation 1.118	2.13 score on a scale Standard Deviation 1.070
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q9: Providing Whole Mouth Comfort(n=53,39)	3.02 score on a scale Standard Deviation 1.118	2.18 score on a scale Standard Deviation 1.073
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q10:Helping to Swallow Without Difficulty(n=49,34)	3.00 score on a scale Standard Deviation 1.041	2.41 score on a scale Standard Deviation 1.184
Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8 Q11: Helping Mouth Feel 'Normal'(n=53,38)	2.92 score on a scale Standard Deviation 1.053	2.26 score on a scale Standard Deviation 1.107

SECONDARY outcome

Timeframe: 60 mins. post treatment on Day 8

Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q13:Long Lasting Lubricating Effect(n=53,36)	2.75 score on a scale Standard Deviation 1.175	1.72 score on a scale Standard Deviation 1.137
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q2: Feeling Comfortable in The Mouth(n=53,39)	2.77 score on a scale Standard Deviation 1.086	2.03 score on a scale Standard Deviation 1.203
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q3: Soothing Your Mouth(n=52,36)	2.79 score on a scale Standard Deviation 1.109	1.92 score on a scale Standard Deviation 1.180
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q4:Allowing to Speak Without Difficulty(n=46,34)	2.96 score on a scale Standard Deviation 1.154	2.44 score on a scale Standard Deviation 1.284
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q5: Effectively Moistens Your Mouth(n= 53,37)	2.79 score on a scale Standard Deviation 1.166	1.95 score on a scale Standard Deviation 1.177
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q6: Effectively Lubricates Your Mouth(52,38)	2.83 score on a scale Standard Deviation 1.133	1.95 score on a scale Standard Deviation 1.184
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q7: Helping to Freshen Your Breath(n=52,32)	2.75 score on a scale Standard Deviation 1.135	1.94 score on a scale Standard Deviation 1.318
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q8:Protecting Your Mouth From Drying Out(n=53,38)	2.77 score on a scale Standard Deviation 1.120	2.00 score on a scale Standard Deviation 1.252
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q9: Providing Whole Mouth Comfort(n=53,38)	2.75 score on a scale Standard Deviation 1.108	1.95 score on a scale Standard Deviation 1.207
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q10:Helping to Swallow Without Difficulty(n=48,32)	2.81 score on a scale Standard Deviation 1.065	2.22 score on a scale Standard Deviation 1.289
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q11: Helping Mouth Feel 'Normal'(n=53,38)	2.77 score on a scale Standard Deviation 1.137	1.97 score on a scale Standard Deviation 1.197
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q12:Having Long Lasting Dry Mouth Relief(n=53,38)	2.72 score on a scale Standard Deviation 1.116	1.82 score on a scale Standard Deviation 1.182
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8 Q14:Long Lasting Moisturizing Effect(n=53,36)	2.74 score on a scale Standard Deviation 1.163	1.78 score on a scale Standard Deviation 1.174

SECONDARY outcome

Timeframe: 120 mins. post treatment on Day 8

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q2: Feeling Comfortable in The Mouth(n=53,39)	2.58 score on a scale Standard Deviation 1.117	1.90 score on a scale Standard Deviation 1.095
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q3: Soothing Your Mouth(n=53,39)	2.57 score on a scale Standard Deviation 1.152	1.85 score on a scale Standard Deviation 1.089
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q4:Allowing to Speak Without Difficulty(n=45,34)	2.67 score on a scale Standard Deviation 1.087	2.26 score on a scale Standard Deviation 1.189
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q5: Effectively Moistens Your Mouth(n= 53,39)	2.60 score on a scale Standard Deviation 1.115	1.77 score on a scale Standard Deviation 1.087
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q6: Effectively Lubricates Your Mouth(53,38)	2.64 score on a scale Standard Deviation 1.194	1.74 score on a scale Standard Deviation 1.107
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q7: Helping to Freshen Your Breath(n=52,33)	2.44 score on a scale Standard Deviation 1.195	1.82 score on a scale Standard Deviation 1.236
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q8: Protecting Your Mouth From Drying Out(53,38)	2.49 score on a scale Standard Deviation 1.137	1.79 score on a scale Standard Deviation 1.143
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q9: Providing Whole Mouth Comfort(n=52,36)	2.54 score on a scale Standard Deviation 1.111	1.86 score on a scale Standard Deviation 1.175
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q10:Helping to Swallow Without Difficulty(n=49,34)	2.63 score on a scale Standard Deviation 1.112	2.03 score on a scale Standard Deviation 1.167
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q11: Helping Mouth Feel 'Normal'(n=53,38)	2.64 score on a scale Standard Deviation 1.128	1.89 score on a scale Standard Deviation 1.085
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q12:Having Long Lasting Dry Mouth Relief(n=53,37)	2.57 score on a scale Standard Deviation 1.233	1.68 score on a scale Standard Deviation 0.973
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q13:Long Lasting Lubricating Effect(n=53,37)	2.57 score on a scale Standard Deviation 1.201	1.73 score on a scale Standard Deviation 1.071
Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8 Q14:Long Lasting Moisturizing Effect(n=53,36)	2.57 score on a scale Standard Deviation 1.169	1.75 score on a scale Standard Deviation 1.052

SECONDARY outcome

Timeframe: 240 mins. post treatment on Day 8

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q2: Feeling Comfortable in The Mouth(n=53,37)	2.47 score on a scale Standard Deviation 1.154	1.81 score on a scale Standard Deviation 1.101
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q3: Soothing Your Mouth(n=53,37)	2.40 score on a scale Standard Deviation 1.182	1.68 score on a scale Standard Deviation 1.002
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q4:Allowing to Speak Without Difficulty(n=46,32)	2.70 score on a scale Standard Deviation 1.113	2.13 score on a scale Standard Deviation 1.212
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q5: Effectively Moistens Your Mouth(n= 53,37)	2.45 score on a scale Standard Deviation 1.202	1.73 score on a scale Standard Deviation 1.071
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q6: Effectively Lubricates Your Mouth(53,36)	2.45 score on a scale Standard Deviation 1.218	1.78 score on a scale Standard Deviation 1.098
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q7: Helping to Freshen Your Breath(n=51,31)	2.45 score on a scale Standard Deviation 1.189	1.74 score on a scale Standard Deviation 1.182
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q8: Protecting Your Mouth From Drying Out(53,37)	2.43 score on a scale Standard Deviation 1.201	1.68 score on a scale Standard Deviation 1.056
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q9: Providing Whole Mouth Comfort(n=53,37)	2.43 score on a scale Standard Deviation 1.135	1.73 score on a scale Standard Deviation 1.018
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q10:Helping to Swallow Without Difficulty(n=48,32)	2.63 score on a scale Standard Deviation 1.214	1.88 score on a scale Standard Deviation 1.129
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q11: Helping Mouth Feel 'Normal'(n=53,36)	2.38 score on a scale Standard Deviation 1.147	1.78 score on a scale Standard Deviation 1.098
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q12:Having Long Lasting Dry Mouth Relief(n=53,37)	2.36 score on a scale Standard Deviation 1.145	1.76 score on a scale Standard Deviation 1.140
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q13:Long Lasting Lubricating Effect(n=53,37)	2.34 score on a scale Standard Deviation 1.192	1.65 score on a scale Standard Deviation 1.086
Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8 Q14:Long Lasting Moisturizing Effect(n=53,37)	2.40 score on a scale Standard Deviation 1.182	1.65 score on a scale Standard Deviation 1.086

SECONDARY outcome

Timeframe: prior to treatment on Day 8

Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Providing Relief All Night(n=47,31)	2.68 score on a scale Standard Deviation 1.163	1.71 score on a scale Standard Deviation 1.160
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Reducing Number of Wake Up from Dry Mouth(n=41,27)	2.80 score on a scale Standard Deviation 1.209	1.81 score on a scale Standard Deviation 1.272
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Feeling Less Parched When You Wake Up(n=47,32)	2.51 score on a scale Standard Deviation 1.196	1.84 score on a scale Standard Deviation 1.110
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having a Long Lasting Dry Mouth Relief(n=47,32)	2.68 score on a scale Standard Deviation 1.270	1.75 score on a scale Standard Deviation 0.950
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having a Long Lasting Lubricating Effect(n=49,33)	2.63 score on a scale Standard Deviation 1.253	1.70 score on a scale Standard Deviation 0.918
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having a Long Lasting Moisturizing Effect(n=48,31)	2.69 score on a scale Standard Deviation 1.257	1.65 score on a scale Standard Deviation 0.915
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having an Overall Dry Mouth Relief(n=49,34)	2.73 score on a scale Standard Deviation 1.132	1.76 score on a scale Standard Deviation 1.017
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having an Overall Lubrication Effect(n=49,32)	2.63 score on a scale Standard Deviation 1.202	1.78 score on a scale Standard Deviation 0.975
Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8 Having an Overall Moisturizing Effect(n=49,33)	2.67 score on a scale Standard Deviation 1.197	1.70 score on a scale Standard Deviation 0.984

SECONDARY outcome

Timeframe: 5 mins post treatment on Day 1

Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1 Having a Immediate Dry Mouth Relief(n=51,45)	3.55 score on a scale Standard Deviation 0.986	3.11 score on a scale Standard Deviation 1.402
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1 Having a Immediate Lubricating Effect(n=53,43)	3.43 score on a scale Standard Deviation 0.971	3.02 score on a scale Standard Deviation 1.371
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1 Having a Immediate Moisturizing Effect(n=53,45)	3.57 score on a scale Standard Deviation 1.029	3.38 score on a scale Standard Deviation 1.211

SECONDARY outcome

Timeframe: 30 mins post treatment on Day 1

Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q1:Relieving the Discomfort Of Dry Mouth(n=53,45)	2.92 score on a scale Standard Deviation 0.958	2.33 score on a scale Standard Deviation 1.261
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q2:Feeling Comfortable in The Mouth(n=52,45)	2.92 score on a scale Standard Deviation 0.926	2.36 score on a scale Standard Deviation 1.151
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q3:Soothing Your Mouth(n=52,45)	2.94 score on a scale Standard Deviation 0.895	2.29 score on a scale Standard Deviation 1.180
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q4:Allowing to Speak Without Difficulty(n=46,41)	3.13 score on a scale Standard Deviation 0.833	2.51 score on a scale Standard Deviation 1.075
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q5: Effectively Moistens Your Mouth(n= 53,44)	3.08 score on a scale Standard Deviation 0.997	2.41 score on a scale Standard Deviation 1.226
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q6: Effectively Lubricates Your Mouth(n=53,45)	3.06 score on a scale Standard Deviation 0.949	2.29 score on a scale Standard Deviation 1.160
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q7: Helping to Freshen Your Breath(n=52,38)	3.21 score on a scale Standard Deviation 0.997	2.03 score on a scale Standard Deviation 1.219
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q8: Protecting Your Mouth From Drying Out(n=53,43)	2.92 score on a scale Standard Deviation 0.997	2.07 score on a scale Standard Deviation 1.280
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q9: Providing Whole Mouth Comfort(n=53,43)	3.06 score on a scale Standard Deviation 0.949	2.35 score on a scale Standard Deviation 1.289
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q10:Helping to Swallow Without Difficulty(n=51,43)	3.06 score on a scale Standard Deviation 0.904	2.60 score on a scale Standard Deviation 1.348
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1 Q11: Helping Mouth Feel 'Normal'(n=53,44)	3.02 score on a scale Standard Deviation 0.951	2.32 score on a scale Standard Deviation 1.377

SECONDARY outcome

Timeframe: 60 mins post treatment on Day 1

Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q1:Relieving the Discomfort Of Dry Mouth(n=53,40)	2.60 score on a scale Standard Deviation 1.044	2.15 score on a scale Standard Deviation 1.272
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q2:Feeling Comfortable in The Mouth(n=53,44)	2.68 score on a scale Standard Deviation 0.915	2.18 score on a scale Standard Deviation 1.167
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q3:Soothing Your Mouth(n=52,42)	2.65 score on a scale Standard Deviation 0.926	2.19 score on a scale Standard Deviation 1.234
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q4:Allowing to Speak Without Difficulty(n=47,39)	3.04 score on a scale Standard Deviation 0.955	2.59 score on a scale Standard Deviation 1.208
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q5: Effectively Moistens Your Mouth(n= 53,43)	2.79 score on a scale Standard Deviation 1.150	2.21 score on a scale Standard Deviation 1.407
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q6: Effectively Lubricates Your Mouth(53,41)	2.70 score on a scale Standard Deviation 1.153	2.02 score on a scale Standard Deviation 1.214
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q7: Helping to Freshen Your Breath(n=51,38)	2.86 score on a scale Standard Deviation 1.059	1.82 score on a scale Standard Deviation 1.159
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q8:Protecting Your Mouth From Drying Out(n=53,41)	2.49 score on a scale Standard Deviation 1.120	2.02 score on a scale Standard Deviation 1.275
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q9: Providing Whole Mouth Comfort(n=53,41)	2.58 score on a scale Standard Deviation 1.027	2.17 score on a scale Standard Deviation 1.160
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q10:Helping to Swallow Without Difficulty(n=51,40)	2.65 score on a scale Standard Deviation 1.036	2.30 score on a scale Standard Deviation 1.244
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q11: Helping Mouth Feel 'Normal'(n=53,43)	2.62 score on a scale Standard Deviation 1.042	2.05 score on a scale Standard Deviation 1.194
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q12:Having Long Lasting Dry Mouth Relief(n=53,43)	2.55 score on a scale Standard Deviation 1.136	1.88 score on a scale Standard Deviation 1.219
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q13:Long Lasting Lubricating Effect(n=53,41)	2.57 score on a scale Standard Deviation 1.152	1.95 score on a scale Standard Deviation 1.264
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1 Q14:Long Lasting Moisturizing Effect(n=53,41)	2.62 score on a scale Standard Deviation 1.113	2.00 score on a scale Standard Deviation 1.245

SECONDARY outcome

Timeframe: 120 mins post treatment on Day 1

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q1:Relieving the Discomfort Of Dry Mouth(n=52,40)	2.48 score on a scale Standard Deviation 1.146	2.13 score on a scale Standard Deviation 1.324
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q2:Feeling Comfortable in The Mouth(n=52,40)	2.56 score on a scale Standard Deviation 1.145	2.10 score on a scale Standard Deviation 1.236
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q3:Soothing Your Mouth(n=52,40)	2.48 score on a scale Standard Deviation 1.075	2.13 score on a scale Standard Deviation 1.305
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q4:Allowing to Speak Without Difficulty(n=48,40)	2.75 score on a scale Standard Deviation 1.194	2.50 score on a scale Standard Deviation 1.240
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q5: Effectively Moistens Your Mouth(n= 52,39)	2.52 score on a scale Standard Deviation 1.229	2.23 score on a scale Standard Deviation 1.441
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q6: Effectively Lubricates Your Mouth(52,39)	2.50 score on a scale Standard Deviation 1.146	2.10 score on a scale Standard Deviation 1.294
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q7: Helping to Freshen Your Breath(n=51,31)	2.59 score on a scale Standard Deviation 1.203	2.00 score on a scale Standard Deviation 1.265
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q8:Protecting Your Mouth From Drying Out(n=53,40)	2.30 score on a scale Standard Deviation 1.153	2.00 score on a scale Standard Deviation 1.281
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q9: Providing Whole Mouth Comfort(n=53,39)	2.45 score on a scale Standard Deviation 1.202	2.21 score on a scale Standard Deviation 1.260
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q10:Helping to Swallow Without Difficulty(n=52,39)	2.48 score on a scale Standard Deviation 1.146	2.28 score on a scale Standard Deviation 1.317
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q11: Helping Mouth Feel 'Normal'(n=52,40)	2.50 score on a scale Standard Deviation 1.146	2.28 score on a scale Standard Deviation 1.261
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q12:Having Long Lasting Dry Mouth Relief(n=52,39)	2.42 score on a scale Standard Deviation 1.194	1.97 score on a scale Standard Deviation 1.347
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q13:Long Lasting Lubricating Effect(n=53,37)	2.36 score on a scale Standard Deviation 1.226	1.92 score on a scale Standard Deviation 1.211
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1 Q14:Long Lasting Moisturizing Effect(n=53,39)	2.42 score on a scale Standard Deviation 1.167	1.95 score on a scale Standard Deviation 1.255

SECONDARY outcome

Timeframe: 240 mins post treatment on Day 1

Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q1:Relieving the Discomfort Of Dry Mouth(n=53,37)	2.38 score on a scale Standard Deviation 1.060	2.03 score on a scale Standard Deviation 1.213
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q2:Feeling Comfortable in The Mouth(n=53,39)	2.49 score on a scale Standard Deviation 1.137	2.08 score on a scale Standard Deviation 1.156
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q3:Soothing Your Mouth(n=52,40)	2.52 score on a scale Standard Deviation 1.146	2.08 score on a scale Standard Deviation 1.163
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q4:Allowing to Speak Without Difficulty(n=47,35)	2.60 score on a scale Standard Deviation 1.116	2.51 score on a scale Standard Deviation 1.222
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q5: Effectively Moistens Your Mouth(n= 52,40)	2.48 score on a scale Standard Deviation 1.196	2.00 score on a scale Standard Deviation 1.132
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q6: Effectively Lubricates Your Mouth(52,39)	2.48 score on a scale Standard Deviation 1.163	1.97 score on a scale Standard Deviation 1.088
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q7: Helping to Freshen Your Breath(n=50,33)	2.28 score on a scale Standard Deviation 1.179	1.64 score on a scale Standard Deviation 1.025
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q8:Protecting Your Mouth From Drying Out(n=53,38)	2.23 score on a scale Standard Deviation 1.137	1.84 score on a scale Standard Deviation 1.175
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q9: Providing Whole Mouth Comfort(n=53,38)	2.38 score on a scale Standard Deviation 1.147	2.08 score on a scale Standard Deviation 1.148
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q10:Helping to Swallow Without Difficulty(n=51,36)	2.37 score on a scale Standard Deviation 1.113	2.25 score on a scale Standard Deviation 1.339
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q11: Helping Mouth Feel 'Normal'(n=53,39)	2.26 score on a scale Standard Deviation 1.163	2.08 score on a scale Standard Deviation 1.133
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q12:Having Long Lasting Dry Mouth Relief(n=51,38)	2.27 score on a scale Standard Deviation 1.168	1.89 score on a scale Standard Deviation 1.110
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q13: Having a Long Lasting Lubricating Effect	2.33 score on a scale Standard Deviation 1.227	1.85 score on a scale Standard Deviation 1.040
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1 Q14: Having a Long Lasting moisturizing effect	2.33 score on a scale Standard Deviation 1.160	1.92 score on a scale Standard Deviation 1.133

SECONDARY outcome

Timeframe: 5 mins post treatment on Day 3

Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=45 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3 Having a Immediate Dry Mouth Relief(n=53,45)	3.55 score on a scale Standard Deviation 1.119	3.16 score on a scale Standard Deviation 1.397
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3 Having a Immediate Lubricating Effect(n=53,44)	3.47 score on a scale Standard Deviation 1.103	2.80 score on a scale Standard Deviation 1.440
Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3 Having a Immediate Moisturizing Effect(n=53,44)	3.51 score on a scale Standard Deviation 1.067	2.89 score on a scale Standard Deviation 1.450

SECONDARY outcome

Timeframe: 30 mins post treatment on Day 3

Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q1:Relieving the Discomfort Of Dry Mouth(n=53,41)	2.91 score on a scale Standard Deviation 1.043	2.29 score on a scale Standard Deviation 1.167
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q2:Feeling Comfortable in The Mouth(n=53,40)	2.96 score on a scale Standard Deviation 1.055	2.35 score on a scale Standard Deviation 1.122
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q3:Soothing Your Mouth(n=53,40)	2.91 score on a scale Standard Deviation 1.097	2.35 score on a scale Standard Deviation 1.272
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q4:Allowing to Speak Without Difficulty(n=46,36)	3.11 score on a scale Standard Deviation 1.100	2.94 score on a scale Standard Deviation 1.286
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q5: Effectively Moistens Your Mouth(n= 53,42)	2.92 score on a scale Standard Deviation 1.035	2.26 score on a scale Standard Deviation 1.270
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q6: Effectively Lubricates Your Mouth(53,40)	2.85 score on a scale Standard Deviation 1.045	2.18 score on a scale Standard Deviation 1.259
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q7: Helping to Freshen Your Breath(n=53,33)	2.94 score on a scale Standard Deviation 1.134	2.06 score on a scale Standard Deviation 1.197
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q8:Protecting Your Mouth From Drying Out(n=53,41)	2.83 score on a scale Standard Deviation 1.122	2.02 score on a scale Standard Deviation 1.235
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q9: Providing Whole Mouth Comfort(n=53,42)	2.87 score on a scale Standard Deviation 1.057	2.24 score on a scale Standard Deviation 1.246
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q10:Helping to Swallow Without Difficulty(n=49,41)	3.00 score on a scale Standard Deviation 1.000	2.34 score on a scale Standard Deviation 1.257
Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3 Q11: Helping Mouth Feel 'Normal'(n=53,42)	2.92 score on a scale Standard Deviation 1.053	2.24 score on a scale Standard Deviation 1.246

SECONDARY outcome

Timeframe: 60 mins. post treatment on Day 3

Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q1:Relieving the Discomfort of Dry Mouth(n=53,39)	2.64 score on a scale Standard Deviation 1.058	2.10 score on a scale Standard Deviation 1.273
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q2:Feeling Comfortable in the Mouth(n=53,39)	2.72 score on a scale Standard Deviation 1.133	2.21 score on a scale Standard Deviation 1.260
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q3:Soothing Your Mouth(n=53,39)	2.66 score on a scale Standard Deviation 1.055	2.21 score on a scale Standard Deviation 1.281
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q4:Allowing to Speak Without Difficulty(n=46,35)	2.89 score on a scale Standard Deviation 1.197	2.63 score on a scale Standard Deviation 1.285
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q5: Effectively Moistens Your Mouth(n= 53,40)	2.60 score on a scale Standard Deviation 1.132	2.23 score on a scale Standard Deviation 1.230
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q6: Effectively Lubricates Your Mouth(53,39)	2.60 score on a scale Standard Deviation 1.115	2.13 score on a scale Standard Deviation 1.361
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q7: Helping to Freshen Your Breath(n=52,34)	2.75 score on a scale Standard Deviation 1.169	1.91 score on a scale Standard Deviation 1.190
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q8:Protecting Your Mouth From Drying Out(n=53,39)	2.60 score on a scale Standard Deviation 1.132	1.92 score on a scale Standard Deviation 1.201
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q9: Providing Whole Mouth Comfort(n=53,40)	2.75 score on a scale Standard Deviation 1.072	2.08 score on a scale Standard Deviation 1.269
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q10:Helping to Swallow Without Difficulty(n=49,37)	2.65 score on a scale Standard Deviation 1.071	2.41 score on a scale Standard Deviation 1.235
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q11: Helping Mouth Feel 'Normal'(n=53,41)	2.58 score on a scale Standard Deviation 1.046	2.20 score on a scale Standard Deviation 1.229
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q12:Having Long Lasting Dry Mouth Relief(n=53,39)	2.55 score on a scale Standard Deviation 1.048	1.92 score on a scale Standard Deviation 1.326
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q13:Long Lasting Lubricating Effect(n=53,40)	2.55 score on a scale Standard Deviation 1.048	2.00 score on a scale Standard Deviation 1.301
Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3 Q14:Long Lasting Moisturizing Effect(n=53,40)	2.62 score on a scale Standard Deviation 1.096	1.98 score on a scale Standard Deviation 1.291

SECONDARY outcome

Timeframe: 120 mins post treatment on Day 3

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q1:Relieving the Discomfort of Dry Mouth(n=53,39)	2.60 score on a scale Standard Deviation 1.261	1.95 score on a scale Standard Deviation 1.297
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q2:Feeling Comfortable in the Mouth(n=53,41)	2.57 score on a scale Standard Deviation 1.169	1.90 score on a scale Standard Deviation 1.114
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q3:Soothing Your Mouth(n=53,40)	2.51 score on a scale Standard Deviation 1.234	1.93 score on a scale Standard Deviation 1.163
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q4:Allowing to Speak Without Difficulty(n=47,35)	2.77 score on a scale Standard Deviation 1.127	2.51 score on a scale Standard Deviation 1.245
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q5: Effectively Moistens Your Mouth(n= 53,41)	2.49 score on a scale Standard Deviation 1.203	1.93 score on a scale Standard Deviation 1.212
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q6: Effectively Lubricates Your Mouth(53,40)	2.53 score on a scale Standard Deviation 1.219	1.95 score on a scale Standard Deviation 1.280
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q7: Helping to Freshen Your Breath(n=52,34)	2.42 score on a scale Standard Deviation 1.242	1.79 score on a scale Standard Deviation 1.149
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q8:Protecting Your Mouth From Drying Out(n=53,38)	2.45 score on a scale Standard Deviation 1.153	1.95 score on a scale Standard Deviation 1.184
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q9: Providing Whole Mouth Comfort(n=53,40)	2.66 score on a scale Standard Deviation 1.208	1.90 score on a scale Standard Deviation 1.150
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q10:Helping to Swallow Without Difficulty(n=50,38)	2.50 score on a scale Standard Deviation 1.233	2.16 score on a scale Standard Deviation 1.263
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q11: Helping Mouth Feel 'Normal'(n=53,39)	2.55 score on a scale Standard Deviation 1.202	2.05 score on a scale Standard Deviation 1.213
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q12:Having Long Lasting Dry Mouth Relief(n=53,37)	2.49 score on a scale Standard Deviation 1.234	1.89 score on a scale Standard Deviation 1.308
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q13:Long Lasting Lubricating Effect(n=53,39)	2.43 score on a scale Standard Deviation 1.185	1.87 score on a scale Standard Deviation 1.260
Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3 Q14:Long Lasting Moisturizing Effect(n=53,41)	2.45 score on a scale Standard Deviation 1.218	1.90 score on a scale Standard Deviation 1.281

SECONDARY outcome

Timeframe: 240 mins post treatment on Day 3

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q1:Relieving the Discomfort of Dry Mouth(n=52,39)	2.37 score on a scale Standard Deviation 1.121	1.77 score on a scale Standard Deviation 1.180
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q2:Feeling Comfortable in the Mouth(n=52,40)	2.42 score on a scale Standard Deviation 1.194	1.80 score on a scale Standard Deviation 1.043
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q3:Soothing Your Mouth(n=52,39)	2.31 score on a scale Standard Deviation 1.130	1.77 score on a scale Standard Deviation 1.111
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q4:Allowing to Speak Without Difficulty(n=45,34)	2.49 score on a scale Standard Deviation 1.121	2.26 score on a scale Standard Deviation 1.286
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q5: Effectively Moistens Your Mouth(n= 52,38)	2.29 score on a scale Standard Deviation 1.143	1.76 score on a scale Standard Deviation 1.149
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q6: Effectively Lubricates Your Mouth(52,39)	2.29 score on a scale Standard Deviation 1.160	1.74 score on a scale Standard Deviation 1.141
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q7: Helping to Freshen Your Breath(n=51,33)	2.33 score on a scale Standard Deviation 1.178	1.76 score on a scale Standard Deviation 1.173
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q8:Protecting Your Mouth From Drying Out(n=52,39)	2.25 score on a scale Standard Deviation 1.153	1.74 score on a scale Standard Deviation 1.117
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q9: Providing Whole Mouth Comfort(n=52,40)	2.31 score on a scale Standard Deviation 1.164	1.75 score on a scale Standard Deviation 1.056
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q10:Helping to Swallow Without Difficulty(n=48,38)	2.38 score on a scale Standard Deviation 1.123	1.92 score on a scale Standard Deviation 1.217
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q11: Helping Mouth Feel 'Normal'(n=52,38)	2.33 score on a scale Standard Deviation 1.184	1.84 score on a scale Standard Deviation 1.103
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q12:Having Long Lasting Dry Mouth Relief(n=52,38)	2.31 score on a scale Standard Deviation 1.164	1.71 score on a scale Standard Deviation 1.206
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q13:Long Lasting Lubricating Effect(n=52,39)	2.23 score on a scale Standard Deviation 1.165	1.72 score on a scale Standard Deviation 1.169
Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3 Q14:Long Lasting Moisturizing Effect(n=52,39)	2.23 score on a scale Standard Deviation 1.148	1.77 score on a scale Standard Deviation 1.158

SECONDARY outcome

Timeframe: Prior to treatment on Day 3

Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to PPAQ4 Prior to Treatment on Day 3 Providing Relief All Night(n=51,34)	2.57 score on a scale Standard Deviation 1.100	2.18 score on a scale Standard Deviation 1.336
Mean Response to PPAQ4 Prior to Treatment on Day 3 Reducing Number of Wake Up from Dry Mouth(n=47,33)	2.81 score on a scale Standard Deviation 1.173	2.18 score on a scale Standard Deviation 1.334
Mean Response to PPAQ4 Prior to Treatment on Day 3 Feeling Less Parched When You Wake Up(n=50,36)	2.52 score on a scale Standard Deviation 1.129	2.11 score on a scale Standard Deviation 1.214
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having a Long Lasting Dry Mouth Relief(n=53,36)	2.43 score on a scale Standard Deviation 1.047	1.86 score on a scale Standard Deviation 1.125
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having a Long Lasting Lubricating Effect(n=53,36)	2.51 score on a scale Standard Deviation 1.067	2.00 score on a scale Standard Deviation 1.219
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having a Long Lasting Moisturizing Effect(n=53,36)	2.47 score on a scale Standard Deviation 1.012	1.86 score on a scale Standard Deviation 1.150
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having an Overall Dry Mouth Relief(n=53,37)	2.45 score on a scale Standard Deviation 1.048	1.95 score on a scale Standard Deviation 1.177
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having an Overall Lubrication Effect(n=53,36)	2.47 score on a scale Standard Deviation 1.049	2.03 score on a scale Standard Deviation 1.183
Mean Response to PPAQ4 Prior to Treatment on Day 3 Having an Overall Moisturizing Effect(n=53,37)	2.45 score on a scale Standard Deviation 1.084	2.03 score on a scale Standard Deviation 1.166

SECONDARY outcome

Timeframe: Prior to treatment on Day 1

Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Your Dry Mouth Cause Discomfort?	2.51 score on a scale Standard Deviation 1.310	2.74 score on a scale Standard Deviation 1.073
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Your Dry Mouth Make Uncomfortable To Speak?	2.13 score on a scale Standard Deviation 1.256	2.06 score on a scale Standard Deviation 1.111
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Your Dry Mouth Interrupt Your Sleep?	2.08 score on a scale Standard Deviation 1.253	2.13 score on a scale Standard Deviation 1.454
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Your Dry Mouth Affect Your Social Interaction	1.58 score on a scale Standard Deviation 1.247	1.51 score on a scale Standard Deviation 1.349
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Your Dry Mouth Cause To Avoid Certain Foods?	1.87 score on a scale Standard Deviation 1.532	1.94 score on a scale Standard Deviation 1.451
Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1 Does Dry Mouth Interfere Your Daily Activities?	1.42 score on a scale Standard Deviation 1.322	1.36 score on a scale Standard Deviation 1.326

SECONDARY outcome

Timeframe: prior to treatment on Day 8

Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Dry Mouth Cause Discomfort?	1.58 score on a scale Standard Deviation 1.216	2.15 score on a scale Standard Deviation 1.215
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Dry Mouth Make Uncomfortable To Speak?	1.00 score on a scale Standard Deviation 1.127	1.32 score on a scale Standard Deviation 1.144
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Dry Mouth Interrupt Your Sleep?	1.15 score on a scale Standard Deviation 1.215	1.66 score on a scale Standard Deviation 1.493
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Dry Mouth Affect Social Interactions?	0.70 score on a scale Standard Deviation 1.030	1.02 score on a scale Standard Deviation 1.242
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Dry Mouth Cause To Avoid Certain Foods?	1.11 score on a scale Standard Deviation 1.368	1.49 score on a scale Standard Deviation 1.333
Mean Response to SAoP QoL 2 Prior to Treatment on Day 8 Has Your Mouth Interfere Daily Activities?	0.83 score on a scale Standard Deviation 1.033	0.87 score on a scale Standard Deviation 1.227

SECONDARY outcome

Timeframe: Prior to treatment on Day 1

Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1:Never in the last week	3 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1: A few days	10 Number of participants	5 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1:Most days	9 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1: Every day	13 Number of participants	11 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1: Several times every day	8 Number of participants	11 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q1: All of the time	10 Number of participants	12 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Strongly disagree	8 Number of participants	8 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Disagree	12 Number of participants	12 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Disagree a little	5 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Agree a little	13 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Agree	14 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q2: Strongly Agree	1 Number of participants	5 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Strongly disagree	3 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Disagree	2 Number of participants	0 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Disagree a little	2 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Agree a little	7 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Agree	26 Number of participants	23 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q3: Strongly agree	13 Number of participants	11 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Strongly disagree	2 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Disagree	5 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Disagree a little	5 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Agree a little	15 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Agree	16 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q4: Strongly agree	10 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5: Strongly disagree	7 Number of participants	8 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5: Disagree	10 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5: Disagree a little	4 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5: Agree a little	14 Number of participants	11 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5:Agree	11 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q5: Strongly Agree	7 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6: Strongly disagree	5 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6: Disagree	3 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6:Disagree a little	4 Number of participants	7 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6: Agree a little	18 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6: Agree	16 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q6: Strongly agree	7 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Strongly disagree	5 Number of participants	5 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Disagree	5 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Disagree a little	6 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Agree a little	17 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Agree	14 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q7: Strongly agree	6 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Strongly disagree	0 Number of participants	1 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Disagree	2 Number of participants	1 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Disagree a little	2 Number of participants	0 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Agree a little	12 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Agree	21 Number of participants	20 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q8: Strongly agree	16 Number of participants	16 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Strongly disagree	1 Number of participants	0 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Disagree	1 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Disagree a little	2 Number of participants	0 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Agree a little	9 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Agree	22 Number of participants	20 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q9: Strongly agree	18 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Strongly disagree	3 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Disagree	9 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Disagree a little	5 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Agree a little	10 Number of participants	12 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Agree	15 Number of participants	16 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q10: Strongly agree	11 Number of participants	8 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Strongly disagree	2 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Disagree	5 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Disagree a little	1 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Agree a little	18 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Agree	13 Number of participants	9 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q11: Strongly agree	14 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Strongly diaagree	3 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Disagree	7 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Disagree a little	3 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Agree a little	17 Number of participants	11 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Agree	13 Number of participants	16 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q12: Strongly agree	10 Number of participants	8 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Strongly disagree	2 Number of participants	3 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Disagree	3 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Disagree a little	7 Number of participants	2 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Agree a little	14 Number of participants	10 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Agree	11 Number of participants	13 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q13: Strongly agree	16 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Strongly disagree	3 Number of participants	5 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Disagree	7 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Disagree a little	4 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Agree a little	14 Number of participants	13 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Agree	18 Number of participants	15 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q14: Strongly agree	7 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Strongly disagree	2 Number of participants	0 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Disagree	5 Number of participants	4 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Disagree a little	1 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Agree a little	9 Number of participants	6 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Agree	8 Number of participants	13 Number of participants
Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1 Q15: Strongly agree	28 Number of participants	18 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 1

Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods \& emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: Never	11 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: A few days	14 Number of participants	19 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: Most days	9 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: Every day	6 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: A few times every day	2 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q16: Many times every day	11 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: Never	16 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: A few days	7 Number of participants	14 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: Most days	9 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: Every day	6 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: A few times every day	10 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q17: Many times every day	5 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: Never	22 Number of participants	19 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: A few days	12 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: Most days	5 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: Every day	4 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: A few times every day	4 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q18: Many times every day	6 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: Never	21 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: A few days	8 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: Most days	6 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: Every day	6 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: A few times every day	2 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q19: Many times every day	10 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Strongly disagree	10 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Disagree	8 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Disagree a little	4 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Agree a little	18 Number of participants	16 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Agree	8 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q20: Strongly agree	5 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Strongly disagree	8 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Disagree	9 Number of participants	14 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Disagree a little	4 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Agree a little	16 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Agree	11 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q21: Strongly agree	5 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Strongly disagree	8 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Disagree	8 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Disagree a little	6 Number of participants	1 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Agree a little	8 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Agree	16 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q22: Strongly agree	7 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Strongly disagree	7 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Disagree	7 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Disagree a little	8 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Agree a little	10 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Agree	12 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q23: Strongly agree	9 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Strongly disagree	7 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Disagree	13 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Disagree a little	9 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Agree a little	13 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Agree	6 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q24: Strongly agree	5 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Strongly disagree	5 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Disagree	10 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Disagree a little	6 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Agree a little	12 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Agree	8 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q25: Strongly agree	12 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26: Strongly disagree	9 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26: Disagree	9 Number of participants	16 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26:Disagree a little	9 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26: Agree a little	20 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26: Agree	3 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q26: Strongly agree	3 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Strongly disagree	6 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Disagree	11 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Disagree a little	7 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Agree a little	13 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Agree	11 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1 Q27: Strongly agree	5 Number of participants	4 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 1

Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Strongly disagree	2 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Disagree	1 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Disagree a little	0 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Agree a little	4 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Agree	14 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q28: Strongly agree	32 Number of participants	27 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Strongly disagree	4 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Disagree	5 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Disagree a little	0 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Agree a little	6 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Agree	16 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q29: Strongly agree	22 Number of participants	19 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Strongly disagree	4 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Disagree	3 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Disagree a little	3 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Agree a little	12 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Agree	10 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q30: Strongly agree	21 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Strongly disagree	3 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Disagree	0 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Disagree a little	2 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Agree a little	5 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Agree	14 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q31: Strongly agree	29 Number of participants	29 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Strongly disagree	4 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Disagree	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Disagree a little	2 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Agree a little	15 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Agree	14 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q32: Strongly agree	12 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Strongly disagree	2 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Disagree	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Disagree a little	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Agree a little	12 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Agree	15 Number of participants	20 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q33: Strongly agree	12 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Strongly disagree	6 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Disagree	12 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Disagree a little	5 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Agree a little	11 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Agree	10 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q34: Strongly agree	9 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Strongly disagree	6 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Disagree	11 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Disagree a little	4 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Agree a little	6 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Agree	14 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q35: Strongly agree	12 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: Never in the last week	20 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: One or two days	5 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: Most days	10 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: Every day	3 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: A few times every day	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q36: Many times every day	9 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: Never in the last week	7 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: One or two days	8 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: Most days	9 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: Every day	10 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: A few times every day	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q37: Many times every day	13 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: Never in the last week	13 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: One or two days	8 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: Most days	8 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: Every day	8 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: A few times every day	10 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q38: Many times every day	6 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: Never in the last week	10 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: One or two days	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: Most days	10 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: Every day	8 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: A few times every day	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1 Q39: Many times every day	13 Number of participants	14 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 1

Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week \& how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ?

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Strongly Disagree	3 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Disagree	6 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Disagree a little	2 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Agree a little	13 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Agree	17 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q40: Strongly agree	12 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Strongly disagree	5 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Disagree	12 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Disagree a little	6 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Agree a little	15 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Agree	6 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q41: Strongly agree	9 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Strongly disagree	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Disagree	12 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Disagree a little	3 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Agree a little	15 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Agree	6 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q42: Strongly agree	11 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Strongly disagree	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Disagree	2 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Disagree a little	3 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Agree a little	10 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Agree	16 Number of participants	21 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q43: Strongly agree	20 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Strongly disagree	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Disagree	8 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Disagree a little	4 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Agree a little	12 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Agree	13 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q44: Strongly agree	14 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Strongly disagree	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Disagree	12 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Disagree a little	7 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Agree a little	14 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Agree	6 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q45: Strongly agree	8 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q46: Excellent	5 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q46: Very Good	12 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q46: Good	20 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q46: Fair	13 Number of participants	15 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 Q46: Poor	3 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Strongly disagree	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Disagree	9 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Disagree a little	5 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Agree a little	17 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Agree	15 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM1: Strongly agree	5 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Strongly disagree	4 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Disagree	11 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Disagree a little	8 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Agree a little	13 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Agree	11 Number of participants	15 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM2: Strongly agree	6 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Strongly disagree	5 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Disagree	17 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Disagree a little	8 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Agree a little	12 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Agree	9 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM3: Strongly agree	2 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Strongly disagree	5 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Disagree	10 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Disagree a little	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Agree a little	17 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Agree	11 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM4: Strongly agree	4 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Strongly disagree	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Disagree	9 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Disagree a little	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Agree a little	16 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Agree	13 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM5: Strongly agree	3 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Strongly disagree	1 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Disagree	7 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Disagree a little	2 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Agree a little	18 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Agree	17 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM6: Strongly agree	8 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Strongly disagree	3 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Disagree	7 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Disagree a little	2 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Agree a little	15 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Agree	16 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM7: Strongly agree	10 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Strongly disagree	3 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Disagree	7 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Disagree a little	5 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Agree a little	16 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Agree	15 Number of participants	22 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM8: Strongly agree	7 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Strongly disagree	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Disagree	13 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Disagree a little	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Agree a little	12 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Agree	10 Number of participants	18 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1 QM9: Strongly agree	6 Number of participants	7 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 8

Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: Never in the last week	8 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: A few days	20 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: Most days	7 Number of participants	14 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: Every day	7 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: Several times every day	3 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q1: All of the time	8 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Strongly disagree	14 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Disagree	11 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Disagree a little	4 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Agree a little	13 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Agree	9 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q2: Strongly agree	2 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Strongly disagree	6 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Disagree	6 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Disagree a little	8 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Agree a little	12 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Agree	13 Number of participants	21 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q3: Strongly agree	8 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Strongly disagree	6 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Disagree	6 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Disagree a little	7 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Agree a little	19 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Agree	12 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q4: Strongly agree	3 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Strongly disagree	13 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Disagree	13 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Disagree a little	6 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Agree a little	14 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Agree	5 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q5: Strongly agree	2 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Strongly disagree	9 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Disagree	7 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Disagree a little	7 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Agree a little	14 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Agree	12 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q6: Strongly agree	4 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Strongly disagree	11 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Disagree	9 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Disagree a little	9 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Agree a little	14 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Agree	9 Number of participants	16 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q7: Strongly agree	1 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Strongly disagree	3 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Disagree	3 Number of participants	1 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Disagree a little	4 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Agree a little	17 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Agree	16 Number of participants	18 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q8: Strongly agree	10 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Strongly disagree	4 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Disagree	4 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Disagree a little	5 Number of participants	0 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Agree a little	14 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Agree	14 Number of participants	21 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q9: Strongly agree	12 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Strongly disagree	8 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Disagree	8 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Disagree a little	7 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Agree a little	12 Number of participants	14 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Agree	12 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q10: Strongly agree	6 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Strongly disagree	6 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Disagree	10 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Disagree a little	7 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Agree a little	13 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Agree	11 Number of participants	16 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q11: Strongly agree	6 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Strongly disagree	7 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Disagree	11 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Disagree a little	10 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Agree a little	14 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Agree	8 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q12: Strongly agree	3 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Strongly disagree	6 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Disagree	11 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Disagree a little	11 Number of participants	1 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Agree a little	15 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Agree	5 Number of participants	14 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q13: Strongly agree	5 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Strongly disagree	6 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Disagree	14 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Disagree a little	11 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Agree a little	12 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Agree	9 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q14: Strongly agree	1 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Strongly disagree	5 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Disagree	7 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Disagree a little	6 Number of participants	0 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Agree a little	13 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Agree	12 Number of participants	16 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8 Q15: Strongly agree	10 Number of participants	14 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 8

Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: Never	16 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: A few days	21 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: Most days	8 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: Every day	3 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: A few times every day	2 Number of participants	6 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q16: Many times every day	3 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: Never	20 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: A few days	20 Number of participants	20 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: Most days	8 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: Every day	0 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: A few times every day	3 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q17: Many times every day	2 Number of participants	1 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: Never	33 Number of participants	19 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: A few days	12 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: Most days	2 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: Every day	3 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: A few times every day	1 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q18: Many times every day	2 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: Never	23 Number of participants	15 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: A few days	13 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: Most days	7 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: Every day	7 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: A few times every day	2 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q19: Many times every day	1 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Strongly disagree	14 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Disagree	17 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Disagree a little	3 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Agree a little	12 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Agree	7 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q20: Strongly agree	0 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Strongly disagree	13 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Disagree	18 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Disagree a little	1 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Agree a little	14 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Agree	6 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q21: Strongly agree	1 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Strongly disagree	11 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Disagree	14 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Disagree a little	3 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Agree a little	17 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Agree	7 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q22: Strongly agree	1 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Strongly disagree	11 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Disagree	14 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Disagree a little	4 Number of participants	4 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Agree a little	13 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Agree	7 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q23: Strongly agree	4 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Strongly disagree	13 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Disagree	15 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Disagree a little	4 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Agree a little	14 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Agree	4 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q24: Strongly agree	3 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Strongly disagree	10 Number of participants	7 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Disagree	9 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Disagree a little	9 Number of participants	3 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Agree a little	12 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Agree	9 Number of participants	13 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q25: Strongly agree	4 Number of participants	5 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Strongly disagree	15 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Disagree	15 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Disagree a little	5 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Agree a little	16 Number of participants	11 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Agree	2 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q26: Strongly agree	0 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Strongly disagree	12 Number of participants	12 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Disagree	14 Number of participants	9 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Disagree a little	2 Number of participants	2 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Agree a little	17 Number of participants	10 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Agree	7 Number of participants	8 Number of participants
Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8 Q27: Strongly agree	1 Number of participants	6 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 8

Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Strongly disagree	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Disagree	0 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Disagree a little	5 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Agree a little	15 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Agree	11 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q28: Strongly agree	20 Number of participants	24 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Strongly disagree	4 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Disagree	9 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Disagree a little	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Agree a little	12 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Agree	12 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q29: Strongly agree	10 Number of participants	19 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Strongly disagree	7 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Disagree	5 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Disagree a little	4 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Agree a little	20 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Agree	10 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q30: Strongly agree	7 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Strongly disagree	6 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Disagree	1 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Disagree a little	1 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Agree a little	9 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Agree	16 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q31: Strongly agree	20 Number of participants	21 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Strongly disagree	6 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Disagree	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Disagree a little	8 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Agree a little	12 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Agree	12 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q32: Strongly agree	9 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Strongly disagree	6 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Disagree	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Disagree a little	6 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Agree a little	13 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Agree	15 Number of participants	17 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q33: Strongly agree	7 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Strongly disagree	10 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Disagree	8 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Disagree a little	10 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Agree a little	15 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Agree	7 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q34: Strongly agree	3 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Strongly disagree	10 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Disagree	9 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Disagree a little	7 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Agree a little	13 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Agree	6 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q35: Strongly agree	8 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: Never in the last week	38 Number of participants	22 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: One or two days	5 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: Most days	4 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: Every day	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: A few times every day	1 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q36: Many times every day	3 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: Never in the last week	20 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: One or two days	10 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: Most days	9 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: Every day	9 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: A few times every day	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q37: Many times every day	3 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: Never in the last week	31 Number of participants	19 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: One or two days	10 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: Most days	3 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: Every day	7 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: A few times every day	0 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q38: Many times every day	2 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: Never in the last week	23 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: One or two days	6 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: Most days	7 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: Every day	8 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: A few times every day	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8 Q39: Many times every day	7 Number of participants	15 Number of participants

SECONDARY outcome

Timeframe: Prior to treatment on Day 8

Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week \& how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ?

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Agree a little	17 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Agree	4 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Strongly agree	1 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Strongly disagree	9 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Disagree	14 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Disagree a little	9 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Agree a little	15 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Agree	5 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM5: Strongly agree	1 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Strongly disagree	5 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Disagree	7 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Disagree a little	6 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Agree a little	23 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Agree	9 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM6: Strongly agree	3 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Strongly disagree	5 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Disagree	10 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Disagree a little	4 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Agree a little	18 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Agree	11 Number of participants	21 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM7: Strongly agree	5 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Strongly disagree	7 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Disagree	10 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Disagree a little	7 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Agree a little	15 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Agree	12 Number of participants	21 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM8: Strongly agree	2 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Strongly disagree	7 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Disagree	16 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Disagree a little	7 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Agree a little	14 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Agree	7 Number of participants	15 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM9: Strongly agree	2 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Strongly disagree	6 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Disagree	12 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Disagree a little	3 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Agree a little	15 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Agree	11 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q40: Strongly agree	6 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Strongly disagree	9 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Disagree	20 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Disagree a little	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Agree a little	10 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Agree	6 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q41: Strongly agree	2 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Strongly disagree	10 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Disagree	14 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Disagree a little	8 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Agree a little	10 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Agree	5 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q42: Strongly agree	6 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Strongly disagree	3 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Disagree	4 Number of participants	1 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Disagree a little	3 Number of participants	0 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Agree a little	12 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Agree	17 Number of participants	18 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q43: Strongly agree	14 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Strongly disagree	3 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Disagree	8 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Disagree a little	9 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Agree a little	8 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Agree	18 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q44: Strongly agree	7 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Strongly disagree	10 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Disagree	16 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Disagree a little	9 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Agree a little	12 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Agree	4 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q45: Strongly agree	2 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q46: Excellent	5 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q46: Very Good	20 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q46: Good	11 Number of participants	12 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q46: Fair	16 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 Q46: Poor	1 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Strongly disagree	5 Number of participants	6 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Disagree	15 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Disagree a little	2 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Agree a little	18 Number of participants	14 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Agree	11 Number of participants	16 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM1: Strongly agree	2 Number of participants	4 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Strongly disagree	7 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Disagree	14 Number of participants	7 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Disagree a little	6 Number of participants	5 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Agree a little	18 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Agree	8 Number of participants	13 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM2: Strongly agree	0 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Strongly disagree	12 Number of participants	11 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Disagree	17 Number of participants	10 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Disagree a little	9 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Agree a little	12 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Agree	3 Number of participants	8 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM3: Strongly agree	0 Number of participants	2 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Strongly disagree	8 Number of participants	3 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Disagree	15 Number of participants	9 Number of participants
Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8 QM4: Disagree a little	8 Number of participants	5 Number of participants

SECONDARY outcome

Timeframe: Day 1, Day 3, Day 8

Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) \& response to these questions was reported. Scale score was averaged to calculate the response

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 1: Q1	4.60 score on a scale Standard Error 0.158	4.81 score on a scale Standard Error 0.168
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 3: Q1	4.64 score on a scale Standard Error 0.161	4.53 score on a scale Standard Error 0.171
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 8: Q1	4.75 score on a scale Standard Error 0.155	4.72 score on a scale Standard Error 0.164
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 1: Q2	3.77 score on a scale Standard Error 0.172	3.54 score on a scale Standard Error 0.183
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 3: Q2	3.67 score on a scale Standard Error 0.164	3.09 score on a scale Standard Error 0.174
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 8: Q2	3.70 score on a scale Standard Error 0.167	3.53 score on a scale Standard Error 0.177
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 1: Q3	5.21 score on a scale Standard Error 0.174	5.76 score on a scale Standard Error 0.184
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 3: Q3	5.32 score on a scale Standard Error 0.158	5.86 score on a scale Standard Error 0.167
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 8: Q3	5.24 score on a scale Standard Error 0.159	5.81 score on a scale Standard Error 0.169
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 1: Q4	4.11 score on a scale Standard Error 0.152	3.38 score on a scale Standard Error 0.161
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 3: Q4	3.93 score on a scale Standard Error 0.155	3.21 score on a scale Standard Error 0.165
Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8 Day 8: Q4	4.09 score on a scale Standard Error 0.150	3.20 score on a scale Standard Error 0.159

SECONDARY outcome

Timeframe: up to 13 days

Population: Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported.

Outcome measures

Outcome measures
Measure	Experimental Mouthwash n=53 Participants During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.	Mineral Water n=47 Participants During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	12 Number of participants	4 Number of participants

Adverse Events

Experimental Mouthwash

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Mineral Water

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Experimental Mouthwash n=53 participants at risk During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.	Mineral Water n=47 participants at risk During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
Gastrointestinal disorders ORAL DISCOMFORT	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders PARAESTHESIA ORAL	3.8% 2/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders TONGUE COATED	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders GLOSSODYNIA	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders LIP DRY	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders SENSITIVITY OF TEETH	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Gastrointestinal disorders STOMATITIS	0.00% 0/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Injury, poisoning and procedural complications BURN ORAL CAVITY	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Injury, poisoning and procedural complications TONGUE INJURY	3.8% 2/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Injury, poisoning and procedural complications LIP INJURY	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Injury, poisoning and procedural complications MOUTH INJURY	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Injury, poisoning and procedural complications TOOTH FRACTURE	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Infections and infestations GASTROENTERITIS VIRAL	1.9% 1/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	0.00% 0/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Infections and infestations HERPES SIMPLEX	0.00% 0/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)
Musculoskeletal and connective tissue disorders SJOGREN'S SYNDROME	0.00% 0/53 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)	2.1% 1/47 • up to 13 days (from screening [Day 1] to 5 days after administration of last product on Day 8)