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A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse

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ClinicalTrials.gov Identifier: NCT04152642
Recruitment Status : Completed
First Posted : November 5, 2019
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Mouth
Interventions Device: Marketed Dry Mouth Rinse
Other: Water control
Device: Experimental Dry Mouth Rinse
Enrollment 22
Recruitment Details  
Pre-assignment Details Subjects that qualified were randomized to one of six treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Subjects had at least a 3 day washout before Period 1 and in-between each period.
Arm/Group Title Overall Study
Hide Arm/Group Description Single-center, randomized 3-treatment, 3-periods cross-over study.
Period Title: Overall Study
Started 22
C (Water/Negative) Control [1] 20
A (Marketed Rinse) [1] 19
B (Experimental Rinse) [1] 19
Completed [2] 15
Not Completed 7
[1]
This was a 3-treatment, 3-period, cross-over design. Each subject was assigned to receive each treatment. Each period lasted 4 days.
[2]
15 subjects received all 3 treatment products
Arm/Group Title Overall Study
Hide Arm/Group Description single-center, randomized 3-treatment, 3-period crossover study
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
41.3  (11.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
16
  72.7%
Male
6
  27.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
22
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  18.2%
White
16
  72.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Dry Mouth Inventory   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
No moisture in the mouth Agree a Little, Agree, or Strongly Agree
19
  86.4%
Disagree a Little, Disagree, or Strongly Disagree
3
  13.6%
Lips sticking to teeth Agree a Little, Agree, or Strongly Agree
18
  81.8%
Disagree a Little, Disagree, or Strongly Disagree
4
  18.2%
Tongue sticking to roof of mouth Agree a Little, Agree, or Strongly Agree
13
  59.1%
Disagree a Little, Disagree, or Strongly Disagree
9
  40.9%
Throat feels dry Agree a Little, Agree, or Strongly Agree
22
 100.0%
Disagree a Little, Disagree, or Strongly Disagree
0
   0.0%
[1]
Measure Description:

subjects had to answer 2 of the 4 dry mouth inventory questions positively. How much do you agree or disagree that you experience the following? (strongly disagree, disagree, disagree a little, agree a little, agree, strongly agree)

  1. No moisture in the mouth
  2. Lips sticking to teeth
  3. Tongue sticking to roof of mouth
  4. Throat feels dry
1.Primary Outcome
Title Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4
Hide Description

Product Performance and Attributes (PPAQ I) Question #1:

Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:

1) Relieves the discomfort of your dry mouth

Time Frame 2-hour, Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Water/Negative Control Marketed Mouth Rinse Experimental Mouth Rinse
Hide Arm/Group Description:

subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.

Water control: negative control

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Overall Number of Participants Analyzed 20 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.79  (0.197) 2.97  (0.204) 3.33  (0.203)
Time Frame Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Water/Negative Control Marketed Mouth Rinse Experimental Mouth Rinse
Hide Arm/Group Description

subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.

Water control: negative control

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.

dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.

Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.

All-Cause Mortality
Water/Negative Control Marketed Mouth Rinse Experimental Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Water/Negative Control Marketed Mouth Rinse Experimental Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Water/Negative Control Marketed Mouth Rinse Experimental Mouth Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/20 (25.00%)   3/19 (15.79%)   2/19 (10.53%) 
Gastrointestinal disorders       
Stomatitis *  3/20 (15.00%)  1/19 (5.26%)  1/19 (5.26%) 
cheilitis *  0/20 (0.00%)  0/19 (0.00%)  1/19 (5.26%) 
Gingival Pain *  0/20 (0.00%)  1/19 (5.26%)  0/19 (0.00%) 
Mouth Ulceration *  0/20 (0.00%)  1/19 (5.26%)  0/19 (0.00%) 
Infections and infestations       
oral herpes *  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%) 
Injury, poisoning and procedural complications       
mouth injury *  1/20 (5.00%)  1/19 (5.26%)  0/19 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: Procter & Gamble
Phone: 5136225362
EMail: combs.cs@pg.com
Layout table for additonal information
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT04152642    
Other Study ID Numbers: CSD2019138
First Submitted: November 1, 2019
First Posted: November 5, 2019
Results First Submitted: November 9, 2020
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021