Trial Outcomes & Findings for Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects (NCT NCT03005041)
NCT ID: NCT03005041
Last Updated: 2018-07-19
Results Overview
Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Within 2 minutes post product use
Results posted on
2018-07-19
Participant Flow
Participants were recruited at a single center in United states of America (U.S.A)
A total 58 participants were screened, out of which 56 participants were enrolled in the study. Two participants were not enrolled as they did not meet the study criteria. Of 56 enrolled participants, 55 participants were randomized as one participant withdrew consent.
Participant milestones
| Measure |
Experimental Oral Rinse/Mineral Water
Participants were supervised to rinse their mouth with 15 milliliter (mL) of the experimental oral rinse/mouth wash swishing followed by with 15mL of mineral water swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
|
Mineral Water/Experimental Oral Rinse
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing followed by with 15mL of experimental oral rinse/mouth wash swishing in period 1 and period 2 respectively. Participants then spat out products after rinsing for 30 seconds. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted. Each period was separated by a washout period of minimum 24 hours to maximum 7 days.
|
|---|---|---|
|
Period 1
STARTED
|
28
|
27
|
|
Period 1
COMPLETED
|
28
|
27
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period 1
STARTED
|
28
|
27
|
|
Washout Period 1
COMPLETED
|
28
|
27
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
28
|
27
|
|
Period 2
COMPLETED
|
28
|
27
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=55 Participants
All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment.
|
|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 14.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 2 minutes post product usePopulation: Analysis for this outcome was performed on intent to treat (ITT) population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..
Outcome measures
| Measure |
Experimental Oral Rinse
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
|
Mineral Water
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
|
|---|---|---|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Disagree Strongly
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Disagree
|
5 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Neither Agree nor Disagree
|
6 Participants
|
5 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Agree
|
26 Participants
|
21 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Agree Strongly
|
17 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Within 2 minutes post product usePopulation: ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. Note: Number of participants who answered question 6 proceeded to answer question 7. Participants also chosen more than one answer for question 7.
Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth \& how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.
Outcome measures
| Measure |
Experimental Oral Rinse
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
|
Mineral Water
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
|
|---|---|---|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Liked it extremely
|
13 Participants
|
7 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Liked it very much
|
27 Participants
|
15 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Liked it somewhat
|
4 Participants
|
13 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Liked it slightly
|
6 Participants
|
9 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Did not like it that much
|
4 Participants
|
7 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q3: Did not Like it at all
|
1 Participants
|
4 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Liked it extremely
|
16 Participants
|
9 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Liked it very much
|
18 Participants
|
9 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Liked it somewhat
|
8 Participants
|
14 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Liked it slightly
|
8 Participants
|
7 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Did not like it that much
|
3 Participants
|
11 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q4: Did not Like it at all
|
2 Participants
|
5 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Strongest flavor imaginable
|
5 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Very strong
|
4 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Strong
|
19 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Moderate
|
27 Participants
|
6 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Weak
|
0 Participants
|
4 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: Barely detectable
|
0 Participants
|
11 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q5: No flavor at all
|
0 Participants
|
33 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Moisturizing): None
|
3 Participants
|
12 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Moisturizing): Mild
|
12 Participants
|
21 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Moisturizing): Moderate
|
30 Participants
|
20 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Moisturizing): Severe
|
10 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Moisturizing)Initially-first contact with mouth
|
30 Participants
|
30 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7Moisturizing:During use-whilst swishing in mouth
|
30 Participants
|
27 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7Moisturizing:After use-spitting out product
|
34 Participants
|
17 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Soothing): None
|
3 Participants
|
15 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Soothing): Mild
|
11 Participants
|
18 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Soothing): Moderate
|
28 Participants
|
19 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Soothing): Severe
|
13 Participants
|
3 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Soothing): Initially - first contact with mouth
|
23 Participants
|
22 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Soothing): During use -whilst swishing in mouth
|
34 Participants
|
30 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Soothing):After use-after spitting out product
|
28 Participants
|
11 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Refreshing): None
|
3 Participants
|
15 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Refreshing): Mild
|
7 Participants
|
19 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Refreshing): Moderate
|
27 Participants
|
19 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Refreshing): Severe
|
18 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Refreshing): Missing
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Refreshing): Initially-first contact with mouth
|
30 Participants
|
20 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Refreshing):During use-whilst swishing in mouth
|
32 Participants
|
22 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Refreshing)After use-after spitting out product
|
32 Participants
|
13 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Tingling): None
|
24 Participants
|
48 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Tingling): Mild
|
13 Participants
|
4 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Tingling): Moderate
|
14 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Tingling): Severe
|
3 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Tingling): Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Tingling): Initially-first contact with mouth
|
10 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Tingling):During use - whilst swishing in mouth
|
17 Participants
|
4 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Tingling):After use -after spitting out product
|
12 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Numbing): None
|
44 Participants
|
52 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Numbing): Mild
|
8 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Numbing): Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Numbing): Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Numbing): Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Numbing): Initially-first contact with mouth
|
3 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Numbing):During use - whilst swishing in mouth
|
2 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Numbing):After use - after spitting out product
|
4 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Burning): None
|
45 Participants
|
53 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Burning): Mild
|
5 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Burning): Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Burning): Severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Burning): Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Burning): Initially-first contact with mouth
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Burning):During use - whilst swishing in mouth
|
4 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Burning):After use - after spitting out product
|
3 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Drying Out): None
|
49 Participants
|
47 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Drying Out): Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Drying Out): Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Drying Out): Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q6(Drying Out): Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Drying Out): Initially-first contact with mouth
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Drying Out):During use-whilst swishing in mouth
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Q7(Drying Out)After use-after spitting out product
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 30 ± 5 minutes post product usePopulation: Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)
Outcome measures
| Measure |
Experimental Oral Rinse
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
|
Mineral Water
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
|
|---|---|---|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Moisturizing: None
|
7 Participants
|
27 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Moisturizing: Mild
|
20 Participants
|
22 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Moisturizing: Moderate
|
23 Participants
|
5 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Moisturizing: Severe
|
5 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Soothing: None
|
9 Participants
|
35 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Soothing: Mild
|
20 Participants
|
14 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Soothing: Moderate
|
24 Participants
|
3 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Soothing: Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Soothing: Missing
|
0 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Refreshing: None
|
10 Participants
|
38 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Refreshing: Mild
|
24 Participants
|
7 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Refreshing: Moderate
|
17 Participants
|
6 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Refreshing: Severe
|
4 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Refreshing: Missing
|
0 Participants
|
3 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Tingling: None
|
46 Participants
|
51 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Tingling: Mild
|
7 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Tingling: Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Tingling: Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Tingling: Missing
|
0 Participants
|
3 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Numbing: None
|
52 Participants
|
50 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Numbing: Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Numbing: Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Numbing: Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Numbing: Missing
|
0 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Burning: None
|
53 Participants
|
51 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Burning: Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Burning: Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Burning: Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Burning: Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Drying Out: None
|
45 Participants
|
36 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Drying Out: Mild
|
6 Participants
|
5 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Drying Out: Moderate
|
1 Participants
|
5 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Drying Out: Severe
|
2 Participants
|
7 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q1: Drying Out: Missing
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q2: Would You Continue Use of The Product? Yes
|
43 Participants
|
20 Participants
|
|
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Q2: Would You Continue Use of The Product? No
|
12 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Within 5 minutes post product usePopulation: Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.
Outcome measures
| Measure |
Experimental Oral Rinse
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental oral rinse/mouth wash use was permitted.
|
Mineral Water
n=55 Participants
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
|
|---|---|---|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q1 · Poor
|
3 Participants
|
10 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q2 · Very good
|
19 Participants
|
9 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q2 · Excellent
|
13 Participants
|
2 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q1 · Excellent
|
14 Participants
|
4 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q1 · Very good
|
22 Participants
|
9 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q1 · Good
|
7 Participants
|
19 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q1 · Fair
|
9 Participants
|
13 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q2 · Good
|
10 Participants
|
13 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q2 · Fair
|
11 Participants
|
16 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q2 · Poor
|
2 Participants
|
15 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q3 · Excellent
|
13 Participants
|
3 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q3 · Very good
|
21 Participants
|
7 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q3 · Good
|
9 Participants
|
18 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q3 · Fair
|
11 Participants
|
13 Participants
|
|
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Q3 · Poor
|
1 Participants
|
14 Participants
|
Adverse Events
Experimental Oral Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mineral Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Oral Rinse
n=55 participants at risk
Participants were supervised to rinse their mouth with 15 mL of the experimental oral rinse/mouth wash swishing for 30 seconds. Participants then spat out product. No rinsing with water immediately after experimental mouth wash use was permitted.
|
Mineral Water
n=55 participants at risk
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
|
|---|---|---|
|
General disorders
Cyst
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
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