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

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04152642
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 3
• Actual Duration (Months): 1
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief Summary

The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.

Condition or Disease	Intervention/Treatment	Phase
Dry Mouth	Device: Marketed Dry Mouth Rinse; Other: Water control; Device: Experimental Dry Mouth Rinse	N/A

Detailed Description

This is a controlled, randomized, 3-treatment, 3-period crossover study in subjects with self-reported dry mouth symptoms as determined by subject responses (as determined by the response to "relieving the discomfort of dry mouth" question from the modified Product Performance and Attributes Questionnaire I/ Moisturization and Dryness (PPAQ I/ MD)) compared to water. Subjects enrollment is based on the responses to the Dry Mouth Inventory (DMI). A sufficient number of volunteers will be screened to ensure enrollment of up to 30 subjects at Acclimation. Subjects who meet the eligibility criteria will continue into the treatment phase of the study. Safety will be assessed by Oral examinations at Baseline/Day1 and Day 4. Subjects will complete questionnaires at Baseline (before product use Day 1 only), after immediate use, 30 minutes, 1 hour, 2 hours, and 4 hours after supervised product use on Day 1 and Day 4 of each period. The PPAQ II questionnaire will be completed in the morning of Day 4 of each period. Subjects will be randomly assigned to treatment sequences at the Baseline visit of Period 1. The treatment and washout periods will be repeated until all three treatment periods have been completed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 3-treatment crossover, with 4 days of use3-treatment crossover, with 4 days of use
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Dec 5, 2019
• Actual Study Completion Date: Dec 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Marketed Mouth Rinse 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.	Device: Marketed Dry Mouth Rinse; relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Experimental: Experimental Mouth Rinse 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.	Device: Experimental Dry Mouth Rinse; relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Sham Comparator: Water/Negative Control 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.	Other: Water control; negative control

Outcome Measures

Primary Outcome Measures

1. Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 [2-hour, Day 4]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• Be at least 18 years of age;

• Be in good general health as determined by the Investigator/designee;

• Agree not to participate in any other oral care studies for the duration of this study;

• Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;

• Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine);

• Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree');

• Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period;

• Agree to return for all scheduled visits and to follow all study procedures.

Exclusion Criteria:

• Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study;

• Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;

• Active treatment for periodontitis;

• Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics;

• Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding;

• Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing;

• Having diabetes;

• Inability to undergo any study procedure;

• Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration);

• Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth;

• Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee);

• Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction);

• Evidence of gross intra-oral neglect or need for extensive dental therapy; or

• Currently undergoing radiotherapy and/or chemotherapy treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Procter & Gamble	Mason	Ohio	United States	45040

Sponsors and Collaborators

• Procter and Gamble

Investigators

• Principal Investigator: Malgorzata Klukowska, DDS, Procter and Gamble

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2019

More Information

Publications

None provided.

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT04152642
• Other Study ID Numbers: CSD2019138
• First Posted: Nov 5, 2019
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Xerostomia

Study Results

Participant Flow

Pre-assignment Detail	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
Arm/Group Description	Single-center, randomized 3-treatment, 3-periods cross-over study.
Period Title: Overall Study
STARTED	22
C (Water/Negative) Control	20
A (Marketed Rinse)	19
B (Experimental Rinse)	19
COMPLETED	15
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	single-center, randomized 3-treatment, 3-period crossover study
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.3 (11.96)
Sex: Female, Male (Count of Participants)
Female	16 72.7%
Male	6 27.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	22 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 9.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 18.2%
White	16 72.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Dry Mouth Inventory (Count of Participants)
Agree a Little, Agree, or Strongly Agree	19 86.4%
Disagree a Little, Disagree, or Strongly Disagree	3 13.6%
Agree a Little, Agree, or Strongly Agree	18 81.8%
Disagree a Little, Disagree, or Strongly Disagree	4 18.2%
Agree a Little, Agree, or Strongly Agree	13 59.1%
Disagree a Little, Disagree, or Strongly Disagree	9 40.9%
Agree a Little, Agree, or Strongly Agree	22 100%
Disagree a Little, Disagree, or Strongly Disagree	0 0%

Outcome Measures

1. Primary Outcome

Title	Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Water/Negative Control	Marketed Mouth Rinse	Experimental Mouth Rinse
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.
Measure Participants	20	19	19
Least Squares Mean (Standard Error) [units on a scale]	1.79 (0.197)	2.97 (0.204)	3.33 (0.203)

Adverse Events

Time Frame	Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
Arm/Group Title	Water/Negative Control		Marketed Mouth Rinse		Experimental Mouth Rinse
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Water/Negative Control		Marketed Mouth Rinse		Experimental Mouth Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Water/Negative Control		Marketed Mouth Rinse		Experimental Mouth Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/20 (25%)		3/19 (15.8%)		2/19 (10.5%)
Gastrointestinal disorders
Stomatitis	3/20 (15%)		1/19 (5.3%)		1/19 (5.3%)
cheilitis	0/20 (0%)		0/19 (0%)		1/19 (5.3%)
Gingival Pain	0/20 (0%)		1/19 (5.3%)		0/19 (0%)
Mouth Ulceration	0/20 (0%)		1/19 (5.3%)		0/19 (0%)
Infections and infestations
oral herpes	1/20 (5%)		0/19 (0%)		0/19 (0%)
Injury, poisoning and procedural complications
mouth injury	1/20 (5%)		1/19 (5.3%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.