Trial Outcomes & Findings for Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray (NCT NCT04186806)

NCT ID: NCT04186806

Last Updated: 2024-10-02

Results Overview

Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 15 minutes post dose
• Results posted on: 2024-10-02

Participant Flow

Participant milestones

Measure	3M Dry Mouth Moisturizing Spray Then Biotene Moisturizing Mouth Spray Dry Mouth Agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle or Dry Mouth Agent: Biotene Moisturizing Mouth Spray: 44 ml bottle	Biotene Moisturizing Mouth Spray Then 3M Dry Mouth Moisturizing Spray Dry mouth agent: Biotene Moisturizing Mouth Spray: 44 ml bottle or Dry mouth agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle
Period 1: 7 Days STARTED	20	20
Period 1: 7 Days COMPLETED	19	20
Period 1: 7 Days NOT COMPLETED	1	0
Washout Period: at Least 2 Days STARTED	19	20
Washout Period: at Least 2 Days COMPLETED	19	20
Washout Period: at Least 2 Days NOT COMPLETED	0	0
Period 2: 7 Days STARTED	19	20
Period 2: 7 Days COMPLETED	19	20
Period 2: 7 Days NOT COMPLETED	0	0

Reasons for withdrawal

Measure	3M Dry Mouth Moisturizing Spray Then Biotene Moisturizing Mouth Spray Dry Mouth Agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle or Dry Mouth Agent: Biotene Moisturizing Mouth Spray: 44 ml bottle	Biotene Moisturizing Mouth Spray Then 3M Dry Mouth Moisturizing Spray Dry mouth agent: Biotene Moisturizing Mouth Spray: 44 ml bottle or Dry mouth agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle
Period 1: 7 Days Adverse Event	1	0

Baseline Characteristics

Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Baseline characteristics by cohort

Measure	3M Spray Then Biotene Spray n=20 Participants 3M Dry Mouth Moisturizing Spray then Biotene Dry Mouth Moisturizing Spray	Biotene Spray Then 3M Spray n=20 Participants Biotene Dry Mouth Moisturizing Spray then 3M Dry Mouth Moisturizing Spray	Total n=40 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 13.67 • n=5 Participants	49.7 years STANDARD_DEVIATION 14.88 • n=7 Participants	49.4 years STANDARD_DEVIATION 14.11 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Currently using Dry Mouth Products Currently using dry mouth products	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Currently using Dry Mouth Products Not currently using dry mouth products	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes post dose

Population: Intent to treat (ITT) with Group Means Imputation

Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Score	4.51 cm Standard Deviation 2.228	4.6 cm Standard Deviation 2.604

SECONDARY outcome

Timeframe: 240 minutes post dose

Population: Intent to Treat (ITT) with Group Means Imputation

Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mean Mouth Dryness Visual Analog Score	5.14 cm Standard Deviation 1.689	5.68 cm Standard Deviation 2.261

SECONDARY outcome

Timeframe: 240 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Score	-2.322 cm Standard Error 0.3115	-1.665 cm Standard Error 0.3576

SECONDARY outcome

Timeframe: 5 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mean Mouth Dryness Visual Analog Score	4.54 cm Standard Deviation 2.128	4.62 cm Standard Deviation 2.703

SECONDARY outcome

Timeframe: 30 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mean Mouth Dryness Visual Analog Scale	4.51 cm Standard Deviation 2.172	4.75 cm Standard Deviation 2.403

SECONDARY outcome

Timeframe: 60 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mean Mouth Dryness Visual Analog Scale	4.58 cm Standard Deviation 2.092	5.04 cm Standard Deviation 2.168

SECONDARY outcome

Timeframe: 120 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mean Mouth Dryness Visual Analog Scale	4.86 cm Standard Deviation 1.832	5.41 cm Standard Deviation 2.143

SECONDARY outcome

Timeframe: 5 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Scale	-2.203 cm Standard Error 0.3042	-1.871 cm Standard Error 0.3780

SECONDARY outcome

Timeframe: 15 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Scale	-2.394 cm Standard Error 0.3095	-2.036 cm Standard Error 0.3476

SECONDARY outcome

Timeframe: 30 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Scale	-2.420 cm Standard Error 0.3111	-1.900 cm Standard Error 0.3176

SECONDARY outcome

Timeframe: 60 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Score	-2.455 cm Standard Error 0.3172	-1.833 cm Standard Error 0.3090

SECONDARY outcome

Timeframe: 120 minutes

Population: Intent to Treat (ITT) with Group Means Imputation

Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=40 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
10 cm Mouth Dryness Visual Analog Score	-2.364 cm Standard Error 0.3108	-1.657 cm Standard Error 0.3281

SECONDARY outcome

Timeframe: 5 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 2=Some/Good	14 Participants	16 Participants
Response on Dry Mouth Relief 3=Very Good	13 Participants	6 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	6 Participants	8 Participants
Response on Dry Mouth Relief 0=No Relief	3 Participants	3 Participants
Response on Dry Mouth Relief 1=Not Enough	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 15 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 0=No Relief	2 Participants	3 Participants
Response on Dry Mouth Relief 1=Not Enough	7 Participants	4 Participants
Response on Dry Mouth Relief 2=Some/Good	10 Participants	19 Participants
Response on Dry Mouth Relief 3=Very Good	16 Participants	8 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 0=No Relief	2 Participants	3 Participants
Response on Dry Mouth Relief 1=Not Enough	6 Participants	6 Participants
Response on Dry Mouth Relief 2=Some/Good	13 Participants	21 Participants
Response on Dry Mouth Relief 3=Very Good	17 Participants	8 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 0=No Relief	3 Participants	4 Participants
Response on Dry Mouth Relief 1=Not Enough	5 Participants	5 Participants
Response on Dry Mouth Relief 2=Some/Good	18 Participants	22 Participants
Response on Dry Mouth Relief 3=Very Good	13 Participants	7 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 120 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 0=No Relief	3 Participants	4 Participants
Response on Dry Mouth Relief 1=Not Enough	10 Participants	14 Participants
Response on Dry Mouth Relief 2=Some/Good	15 Participants	15 Participants
Response on Dry Mouth Relief 3=Very Good	11 Participants	5 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 240 minutes

Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response on Dry Mouth Relief 0=No Relief	6 Participants	6 Participants
Response on Dry Mouth Relief 1=Not Enough	13 Participants	16 Participants
Response on Dry Mouth Relief 2=Some/Good	12 Participants	11 Participants
Response on Dry Mouth Relief 3=Very Good	9 Participants	5 Participants
Response on Dry Mouth Relief 4=Significant/Excellent	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	2 Participants	3 Participants
Response to Effectively Lubricates the Mouth 2= Fair	7 Participants	8 Participants
Response to Effectively Lubricates the Mouth 3= Good	10 Participants	16 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	14 Participants	4 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 15 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	2 Participants	3 Participants
Response to Effectively Lubricates the Mouth 2= Fair	8 Participants	7 Participants
Response to Effectively Lubricates the Mouth 3= Good	10 Participants	17 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	15 Participants	6 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 30 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	2 Participants	3 Participants
Response to Effectively Lubricates the Mouth 2= Fair	9 Participants	12 Participants
Response to Effectively Lubricates the Mouth 3= Good	13 Participants	15 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	15 Participants	8 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	4 Participants	3 Participants
Response to Effectively Lubricates the Mouth 2= Fair	11 Participants	15 Participants
Response to Effectively Lubricates the Mouth 3= Good	14 Participants	13 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	10 Participants	7 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 120 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	5 Participants	9 Participants
Response to Effectively Lubricates the Mouth 2= Fair	15 Participants	12 Participants
Response to Effectively Lubricates the Mouth 3= Good	12 Participants	12 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	7 Participants	5 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 240 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Lubricates the Mouth 1= Poor	9 Participants	9 Participants
Response to Effectively Lubricates the Mouth 2= Fair	14 Participants	18 Participants
Response to Effectively Lubricates the Mouth 3= Good	10 Participants	6 Participants
Response to Effectively Lubricates the Mouth 4= Very Good	6 Participants	4 Participants
Response to Effectively Lubricates the Mouth 5= Excellent	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 5 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	1 Participants	2 Participants
Response to Feel Comfortable in the Mouth 2= Fair	5 Participants	7 Participants
Response to Feel Comfortable in the Mouth 3= Good	13 Participants	15 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	11 Participants	6 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	10 Participants	9 Participants

SECONDARY outcome

Timeframe: 15 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	1 Participants	2 Participants
Response to Feel Comfortable in the Mouth 2= Fair	5 Participants	6 Participants
Response to Feel Comfortable in the Mouth 3= Good	14 Participants	16 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	13 Participants	8 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 30 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	1 Participants	3 Participants
Response to Feel Comfortable in the Mouth 2= Fair	6 Participants	6 Participants
Response to Feel Comfortable in the Mouth 3= Good	14 Participants	20 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	16 Participants	6 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 60 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	2 Participants	3 Participants
Response to Feel Comfortable in the Mouth 2= Fair	9 Participants	11 Participants
Response to Feel Comfortable in the Mouth 3= Good	15 Participants	13 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	11 Participants	10 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 120 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	4 Participants	4 Participants
Response to Feel Comfortable in the Mouth 2= Fair	14 Participants	11 Participants
Response to Feel Comfortable in the Mouth 3= Good	10 Participants	14 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	9 Participants	8 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 240 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Feel Comfortable in the Mouth 1= Poor	5 Participants	6 Participants
Response to Feel Comfortable in the Mouth 2= Fair	14 Participants	14 Participants
Response to Feel Comfortable in the Mouth 3= Good	12 Participants	11 Participants
Response to Feel Comfortable in the Mouth 4= Very Good	6 Participants	5 Participants
Response to Feel Comfortable in the Mouth 5= Excellent	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	1 Participants	1 Participants
Response to Soothing in the Mouth 2= Fair	6 Participants	7 Participants
Response to Soothing in the Mouth 3= Good	10 Participants	16 Participants
Response to Soothing in the Mouth 4= Very Good	12 Participants	6 Participants
Response to Soothing in the Mouth 5= Excellent	11 Participants	9 Participants

SECONDARY outcome

Timeframe: 15 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	1 Participants	1 Participants
Response to Soothing in the Mouth 2= Fair	7 Participants	8 Participants
Response to Soothing in the Mouth 3= Good	11 Participants	17 Participants
Response to Soothing in the Mouth 4= Very Good	13 Participants	6 Participants
Response to Soothing in the Mouth 5= Excellent	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 30 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	1 Participants	2 Participants
Response to Soothing in the Mouth 2= Fair	8 Participants	12 Participants
Response to Soothing in the Mouth 3= Good	14 Participants	15 Participants
Response to Soothing in the Mouth 4= Very Good	13 Participants	8 Participants
Response to Soothing in the Mouth 5= Excellent	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 60 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	3 Participants	3 Participants
Response to Soothing in the Mouth 2= Fair	10 Participants	12 Participants
Response to Soothing in the Mouth 3= Good	13 Participants	15 Participants
Response to Soothing in the Mouth 4= Very Good	12 Participants	7 Participants
Response to Soothing in the Mouth 5= Excellent	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 120 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	4 Participants	7 Participants
Response to Soothing in the Mouth 2= Fair	14 Participants	11 Participants
Response to Soothing in the Mouth 3= Good	12 Participants	13 Participants
Response to Soothing in the Mouth 4= Very Good	8 Participants	6 Participants
Response to Soothing in the Mouth 5= Excellent	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 240 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Soothing in the Mouth 1= Poor	7 Participants	8 Participants
Response to Soothing in the Mouth 2= Fair	16 Participants	15 Participants
Response to Soothing in the Mouth 3= Good	8 Participants	9 Participants
Response to Soothing in the Mouth 4= Very Good	7 Participants	4 Participants
Response to Soothing in the Mouth 5= Excellent	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 1= Poor	3 Participants	3 Participants
Response to Effectively Moistens the Mouth 2= Fair	5 Participants	6 Participants
Response to Effectively Moistens the Mouth 3= Good	11 Participants	17 Participants
Response to Effectively Moistens the Mouth 4= Very Good	12 Participants	5 Participants
Response to Effectively Moistens the Mouth 5= Excellent	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 15 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 1= Poor	2 Participants	3 Participants
Response to Effectively Moistens the Mouth 2= Fair	7 Participants	6 Participants
Response to Effectively Moistens the Mouth 3= Good	12 Participants	18 Participants
Response to Effectively Moistens the Mouth 4= Very Good	12 Participants	6 Participants
Response to Effectively Moistens the Mouth 5= Excellent	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 30 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 1= Poor	3 Participants	3 Participants
Response to Effectively Moistens the Mouth 2= Fair	7 Participants	9 Participants
Response to Effectively Moistens the Mouth 3= Good	14 Participants	19 Participants
Response to Effectively Moistens the Mouth 4= Very Good	13 Participants	7 Participants
Response to Effectively Moistens the Mouth 5= Excellent	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 3= Good	13 Participants	15 Participants
Response to Effectively Moistens the Mouth 4= Very Good	9 Participants	8 Participants
Response to Effectively Moistens the Mouth 1= Poor	5 Participants	3 Participants
Response to Effectively Moistens the Mouth 2= Fair	11 Participants	12 Participants
Response to Effectively Moistens the Mouth 5= Excellent	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 120 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 1= Poor	6 Participants	8 Participants
Response to Effectively Moistens the Mouth 2= Fair	16 Participants	15 Participants
Response to Effectively Moistens the Mouth 3= Good	9 Participants	9 Participants
Response to Effectively Moistens the Mouth 4= Very Good	8 Participants	6 Participants
Response to Effectively Moistens the Mouth 5= Excellent	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 240 minutes

5 point ordinal scale 1 = Poor and 5 = Excellent

Outcome measures

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 Participants Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 Participants Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Response to Effectively Moistens the Mouth 1= Poor	12 Participants	8 Participants
Response to Effectively Moistens the Mouth 2= Fair	12 Participants	20 Participants
Response to Effectively Moistens the Mouth 3= Good	8 Participants	5 Participants
Response to Effectively Moistens the Mouth 4= Very Good	8 Participants	4 Participants
Response to Effectively Moistens the Mouth 5= Excellent	0 Participants	2 Participants

Adverse Events

3M(TM) Dry Mouth Moisturizing Spray

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Biotene Moisturizing Mouth Spray

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 participants at risk Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 participants at risk Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Skin and subcutaneous tissue disorders Skin Ulceration	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm

Other adverse events

Measure	3M(TM) Dry Mouth Moisturizing Spray n=40 participants at risk Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml	Biotene Moisturizing Mouth Spray n=39 participants at risk Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/40 • For the entire 7 day treatment period for each study arm	2.6% 1/39 • Number of events 1 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Diarrhea	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Dry Mouth	0.00% 0/40 • For the entire 7 day treatment period for each study arm	2.6% 1/39 • Number of events 1 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Dysgeusia	5.0% 2/40 • Number of events 2 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Hypoesthesia Oral	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	2.6% 1/39 • Number of events 1 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Oral Discomfort	0.00% 0/40 • For the entire 7 day treatment period for each study arm	5.1% 2/39 • Number of events 2 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Oropharyngeal Pain	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Paresthesia Oral	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	5.1% 2/39 • Number of events 2 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Salivary Hypersecretion	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	2.6% 1/39 • Number of events 1 • For the entire 7 day treatment period for each study arm
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/40 • For the entire 7 day treatment period for each study arm	2.6% 1/39 • Number of events 1 • For the entire 7 day treatment period for each study arm
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • For the entire 7 day treatment period for each study arm	0.00% 0/39 • For the entire 7 day treatment period for each study arm

Additional Information

Elaine Egging/Project Manger

3M Health Care

Phone: 651-737-0263

Email: eegging@mmm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place