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Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects

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ClinicalTrials.gov Identifier: NCT03005041
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : April 3, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Xerostomia
Interventions Other: Biotene mouthwash
Other: Bottled mineral water
Enrollment 56

Recruitment Details Participants were recruited at a single center in United states of America (U.S.A)
Pre-assignment Details 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.
Arm/Group Title Experimental Oral Rinse/Mineral Water Mineral Water/Experimental Oral Rinse
Hide Arm/Group Description 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. 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 Title: Period 1
Started 28 27
Completed 28 27
Not Completed 0 0
Period Title: Washout Period 1
Started 28 27
Completed 28 27
Not Completed 0 0
Period Title: Period 2
Started 28 27
Completed 28 27
Not Completed 0 0
Arm/Group Title Overall Study Participants
Hide Arm/Group Description All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
54.2  (14.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
15
  27.3%
Male
40
  72.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Hispanic or Latino
7
  12.7%
Not Hispanic or Latino
48
  87.3%
1.Primary Outcome
Title Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Hide Description 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..
Time Frame Within 2 minutes post product use
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental Oral Rinse Mineral Water
Hide Arm/Group Description:
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.
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Disagree Strongly
1
   1.8%
1
   1.8%
Disagree
5
   9.1%
0
   0.0%
Neither Agree nor Disagree
6
  10.9%
5
   9.1%
Agree
26
  47.3%
21
  38.2%
Agree Strongly
17
  30.9%
28
  50.9%
2.Secondary Outcome
Title Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Hide Description 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.
Time Frame Within 2 minutes post product use
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental Oral Rinse Mineral Water
Hide Arm/Group Description:
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.
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Q3: Liked it extremely Number Analyzed 55 participants 55 participants
13
  23.6%
7
  12.7%
Q3: Liked it very much Number Analyzed 55 participants 55 participants
27
  49.1%
15
  27.3%
Q3: Liked it somewhat Number Analyzed 55 participants 55 participants
4
   7.3%
13
  23.6%
Q3: Liked it slightly Number Analyzed 55 participants 55 participants
6
  10.9%
9
  16.4%
Q3: Did not like it that much Number Analyzed 55 participants 55 participants
4
   7.3%
7
  12.7%
Q3: Did not Like it at all Number Analyzed 55 participants 55 participants
1
   1.8%
4
   7.3%
Q4: Liked it extremely Number Analyzed 55 participants 55 participants
16
  29.1%
9
  16.4%
Q4: Liked it very much Number Analyzed 55 participants 55 participants
18
  32.7%
9
  16.4%
Q4: Liked it somewhat Number Analyzed 55 participants 55 participants
8
  14.5%
14
  25.5%
Q4: Liked it slightly Number Analyzed 55 participants 55 participants
8
  14.5%
7
  12.7%
Q4: Did not like it that much Number Analyzed 55 participants 55 participants
3
   5.5%
11
  20.0%
Q4: Did not Like it at all Number Analyzed 55 participants 55 participants
2
   3.6%
5
   9.1%
Q5: Strongest flavor imaginable Number Analyzed 55 participants 55 participants
5
   9.1%
0
   0.0%
Q5: Very strong Number Analyzed 55 participants 55 participants
4
   7.3%
1
   1.8%
Q5: Strong Number Analyzed 55 participants 55 participants
19
  34.5%
0
   0.0%
Q5: Moderate Number Analyzed 55 participants 55 participants
27
  49.1%
6
  10.9%
Q5: Weak Number Analyzed 55 participants 55 participants
0
   0.0%
4
   7.3%
Q5: Barely detectable Number Analyzed 55 participants 55 participants
0
   0.0%
11
  20.0%
Q5: No flavor at all Number Analyzed 55 participants 55 participants
0
   0.0%
33
  60.0%
Q6(Moisturizing): None Number Analyzed 55 participants 55 participants
3
   5.5%
12
  21.8%
Q6(Moisturizing): Mild Number Analyzed 55 participants 55 participants
12
  21.8%
21
  38.2%
Q6(Moisturizing): Moderate Number Analyzed 55 participants 55 participants
30
  54.5%
20
  36.4%
Q6(Moisturizing): Severe Number Analyzed 55 participants 55 participants
10
  18.2%
2
   3.6%
Q7(Moisturizing)Initially-first contact with mouth Number Analyzed 52 participants 43 participants
30
  57.7%
30
  69.8%
Q7Moisturizing:During use-whilst swishing in mouth Number Analyzed 52 participants 43 participants
30
  57.7%
27
  62.8%
Q7Moisturizing:After use-spitting out product Number Analyzed 52 participants 43 participants
34
  65.4%
17
  39.5%
Q6(Soothing): None Number Analyzed 55 participants 55 participants
3
   5.5%
15
  27.3%
Q6(Soothing): Mild Number Analyzed 55 participants 55 participants
11
  20.0%
18
  32.7%
Q6(Soothing): Moderate Number Analyzed 55 participants 55 participants
28
  50.9%
19
  34.5%
Q6(Soothing): Severe Number Analyzed 55 participants 55 participants
13
  23.6%
3
   5.5%
Q7(Soothing): Initially - first contact with mouth Number Analyzed 52 participants 40 participants
23
  44.2%
22
  55.0%
Q7(Soothing): During use -whilst swishing in mouth Number Analyzed 52 participants 40 participants
34
  65.4%
30
  75.0%
Q7(Soothing):After use-after spitting out product Number Analyzed 52 participants 40 participants
28
  53.8%
11
  27.5%
Q6(Refreshing): None Number Analyzed 55 participants 55 participants
3
   5.5%
15
  27.3%
Q6(Refreshing): Mild Number Analyzed 55 participants 55 participants
7
  12.7%
19
  34.5%
Q6(Refreshing): Moderate Number Analyzed 55 participants 55 participants
27
  49.1%
19
  34.5%
Q6(Refreshing): Severe Number Analyzed 55 participants 55 participants
18
  32.7%
1
   1.8%
Q6(Refreshing): Missing Number Analyzed 55 participants 55 participants
0
   0.0%
1
   1.8%
Q7(Refreshing): Initially-first contact with mouth Number Analyzed 52 participants 39 participants
30
  57.7%
20
  51.3%
Q7(Refreshing):During use-whilst swishing in mouth Number Analyzed 52 participants 39 participants
32
  61.5%
22
  56.4%
Q7(Refreshing)After use-after spitting out product Number Analyzed 52 participants 39 participants
32
  61.5%
13
  33.3%
Q6(Tingling): None Number Analyzed 55 participants 55 participants
24
  43.6%
48
  87.3%
Q6(Tingling): Mild Number Analyzed 55 participants 55 participants
13
  23.6%
4
   7.3%
Q6(Tingling): Moderate Number Analyzed 55 participants 55 participants
14
  25.5%
1
   1.8%
Q6(Tingling): Severe Number Analyzed 55 participants 55 participants
3
   5.5%
0
   0.0%
Q6(Tingling): Missing Number Analyzed 55 participants 55 participants
1
   1.8%
2
   3.6%
Q7(Tingling): Initially-first contact with mouth Number Analyzed 30 participants 5 participants
10
  33.3%
0
   0.0%
Q7(Tingling):During use - whilst swishing in mouth Number Analyzed 30 participants 5 participants
17
  56.7%
4
  80.0%
Q7(Tingling):After use -after spitting out product Number Analyzed 30 participants 5 participants
12
  40.0%
1
  20.0%
Q6(Numbing): None Number Analyzed 55 participants 55 participants
44
  80.0%
52
  94.5%
Q6(Numbing): Mild Number Analyzed 55 participants 55 participants
8
  14.5%
0
   0.0%
Q6(Numbing): Moderate Number Analyzed 55 participants 55 participants
2
   3.6%
1
   1.8%
Q6(Numbing): Severe Number Analyzed 55 participants 55 participants
0
   0.0%
0
   0.0%
Q6(Numbing): Missing Number Analyzed 55 participants 55 participants
1
   1.8%
2
   3.6%
Q7(Numbing): Initially-first contact with mouth Number Analyzed 10 participants 1 participants
3
  30.0%
1
 100.0%
Q7(Numbing):During use - whilst swishing in mouth Number Analyzed 10 participants 1 participants
2
  20.0%
1
 100.0%
Q7(Numbing):After use - after spitting out product Number Analyzed 10 participants 1 participants
4
  40.0%
0
   0.0%
Q6(Burning): None Number Analyzed 55 participants 55 participants
45
  81.8%
53
  96.4%
Q6(Burning): Mild Number Analyzed 55 participants 55 participants
5
   9.1%
0
   0.0%
Q6(Burning): Moderate Number Analyzed 55 participants 55 participants
2
   3.6%
0
   0.0%
Q6(Burning): Severe Number Analyzed 55 participants 55 participants
2
   3.6%
0
   0.0%
Q6(Burning): Missing Number Analyzed 55 participants 55 participants
1
   1.8%
2
   3.6%
Q7(Burning): Initially-first contact with mouth Number Analyzed 9 participants 0 participants
2
  22.2%
0
Q7(Burning):During use - whilst swishing in mouth Number Analyzed 9 participants 0 participants
4
  44.4%
0
Q7(Burning):After use - after spitting out product Number Analyzed 9 participants 0 participants
3
  33.3%
0
Q6(Drying Out): None Number Analyzed 55 participants 55 participants
49
  89.1%
47
  85.5%
Q6(Drying Out): Mild Number Analyzed 55 participants 55 participants
4
   7.3%
3
   5.5%
Q6(Drying Out): Moderate Number Analyzed 55 participants 55 participants
1
   1.8%
1
   1.8%
Q6(Drying Out): Severe Number Analyzed 55 participants 55 participants
0
   0.0%
2
   3.6%
Q6(Drying Out): Missing Number Analyzed 55 participants 55 participants
1
   1.8%
2
   3.6%
Q7(Drying Out): Initially-first contact with mouth Number Analyzed 5 participants 6 participants
1
  20.0%
2
  33.3%
Q7(Drying Out):During use-whilst swishing in mouth Number Analyzed 5 participants 6 participants
1
  20.0%
1
  16.7%
Q7(Drying Out)After use-after spitting out product Number Analyzed 5 participants 6 participants
5
 100.0%
4
  66.7%
3.Secondary Outcome
Title Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Hide Description 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)
Time Frame Within 30 ± 5 minutes post product use
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental Oral Rinse Mineral Water
Hide Arm/Group Description:
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.
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Q1: Moisturizing: None
7
  12.7%
27
  49.1%
Q1: Moisturizing: Mild
20
  36.4%
22
  40.0%
Q1: Moisturizing: Moderate
23
  41.8%
5
   9.1%
Q1: Moisturizing: Severe
5
   9.1%
1
   1.8%
Q1: Soothing: None
9
  16.4%
35
  63.6%
Q1: Soothing: Mild
20
  36.4%
14
  25.5%
Q1: Soothing: Moderate
24
  43.6%
3
   5.5%
Q1: Soothing: Severe
2
   3.6%
1
   1.8%
Q1: Soothing: Missing
0
   0.0%
2
   3.6%
Q1: Refreshing: None
10
  18.2%
38
  69.1%
Q1: Refreshing: Mild
24
  43.6%
7
  12.7%
Q1: Refreshing: Moderate
17
  30.9%
6
  10.9%
Q1: Refreshing: Severe
4
   7.3%
1
   1.8%
Q1: Refreshing: Missing
0
   0.0%
3
   5.5%
Q1: Tingling: None
46
  83.6%
51
  92.7%
Q1: Tingling: Mild
7
  12.7%
1
   1.8%
Q1: Tingling: Moderate
2
   3.6%
0
   0.0%
Q1: Tingling: Severe
0
   0.0%
0
   0.0%
Q1: Tingling: Missing
0
   0.0%
3
   5.5%
Q1: Numbing: None
52
  94.5%
50
  90.9%
Q1: Numbing: Mild
2
   3.6%
2
   3.6%
Q1: Numbing: Moderate
1
   1.8%
1
   1.8%
Q1: Numbing: Severe
0
   0.0%
0
   0.0%
Q1: Numbing: Missing
0
   0.0%
2
   3.6%
Q1: Burning: None
53
  96.4%
51
  92.7%
Q1: Burning: Mild
1
   1.8%
0
   0.0%
Q1: Burning: Moderate
0
   0.0%
1
   1.8%
Q1: Burning: Severe
0
   0.0%
1
   1.8%
Q1: Burning: Missing
1
   1.8%
2
   3.6%
Q1: Drying Out: None
45
  81.8%
36
  65.5%
Q1: Drying Out: Mild
6
  10.9%
5
   9.1%
Q1: Drying Out: Moderate
1
   1.8%
5
   9.1%
Q1: Drying Out: Severe
2
   3.6%
7
  12.7%
Q1: Drying Out: Missing
1
   1.8%
2
   3.6%
Q2: Would You Continue Use of The Product? Yes
43
  78.2%
20
  36.4%
Q2: Would You Continue Use of The Product? No
12
  21.8%
35
  63.6%
4.Secondary Outcome
Title Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Hide Description 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.
Time Frame Within 5 minutes post product use
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental Oral Rinse Mineral Water
Hide Arm/Group Description:
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.
Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Q1 Excellent
14
  25.5%
4
   7.3%
Very good
22
  40.0%
9
  16.4%
Good
7
  12.7%
19
  34.5%
Fair
9
  16.4%
13
  23.6%
Poor
3
   5.5%
10
  18.2%
Q2 Excellent
13
  23.6%
2
   3.6%
Very good
19
  34.5%
9
  16.4%
Good
10
  18.2%
13
  23.6%
Fair
11
  20.0%
16
  29.1%
Poor
2
   3.6%
15
  27.3%
Q3 Excellent
13
  23.6%
3
   5.5%
Very good
21
  38.2%
7
  12.7%
Good
9
  16.4%
18
  32.7%
Fair
11
  20.0%
13
  23.6%
Poor
1
   1.8%
14
  25.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Oral Rinse Mineral Water
Hide Arm/Group Description 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. Participants were supervised to rinse their mouth with 15 mL of the mineral water swishing for 30 seconds. Participants then spat out the water.
All-Cause Mortality
Experimental Oral Rinse Mineral Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/55 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Oral Rinse Mineral Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Experimental Oral Rinse Mineral Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/55 (1.82%)      0/55 (0.00%)    
General disorders     
Cyst  1/55 (1.82%)  1 0/55 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03005041     History of Changes
Other Study ID Numbers: 205067
First Submitted: August 30, 2016
First Posted: December 29, 2016
Results First Submitted: August 31, 2017
Results First Posted: April 3, 2018
Last Update Posted: July 19, 2018