Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04189081
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 74.5

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate dry mouth relief in subjects with self-reported feeling of dry mouth after using an experimental mouth rinse or a positive control compared to a water control.

Condition or Disease	Intervention/Treatment	Phase
Dry Mouth	Device: dry mouth rinse; Other: Water Control	N/A

Detailed Description

This is a controlled, randomized, 3-treatment, parallel study for subjects with self-reported dry mouth symptoms as determined by an Oral Examination and subject responses to the Dry Mouth Inventory (DMI) questionnaire (see section 12) at the Acclimation visit. Qualified subjects will be randomly assigned to one of three treatments at the Baseline visit. Safety will be assessed by Oral Examinations at Baseline/Day1 and Day 8. Subjects will complete questionnaires before product use, immediately after product use (Day 1 only), and after 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours of product use on Baseline/Day 1 and Day 8. The PPAQ II questionnaire will be completed on the morning of Day 8 (see study schedule for details).

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control
• Actual Study Start Date: May 13, 2020
• Actual Primary Completion Date: Jul 8, 2020
• Actual Study Completion Date: Jul 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.	Device: dry mouth rinse; relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Sham Comparator: Water Control Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.	Other: Water Control; negative control
Active Comparator: Positive Control dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.	Device: dry mouth rinse; relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Outcome Measures

Primary Outcome Measures

1. Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment [4-hours]

   Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth

2. Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment [6-hours]

   Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for 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;

• Sign a Confidentiality Disclosure Agree(CDA) form and be given a signed copy;

• Be at least 18 years of age;

• 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 eating, drinking, smoking, using oral care products, using tobacco, using a medicated lozenge, chewing gum, or breath mints during the 6-hour test period (except snack after 4-hour Questionnaire);

• 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;

• 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); or

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salus Research	Fort Wayne	Indiana	United States	46825

Sponsors and Collaborators

• Procter and Gamble

Investigators

• Principal Investigator: Jeff Milleman, DDS, Procter and Gamble

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 1, 2020

More Information

Publications

None provided.

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT04189081
• Other Study ID Numbers: CSD2019158
• First Posted: Dec 6, 2019
• Last Update Posted: May 28, 2021
• Last Verified: May 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

Recruitment Details

Self-reported a dry mouth feeling according to the modified DMI questions (Subject must have answered at least 2 out of 4 questions below with 'agree a little,' 'agree' or 'strongly agree'): How much do you agree or disagree that you experience the following? (strongly disagree, disagree, disagree a little, agree a little, agree, strongly agree) No moisture in the mouth Lips sticking to teeth Tongue sticking to roof of mouth Throat feels dry

Arm/Group Title	Water Control	Experimental Mouth Rinse	Positive Control
Arm/Group Description	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Period Title: Overall Study
STARTED	46	45	46
COMPLETED	45	45	45
NOT COMPLETED	1	0	1

Baseline Characteristics

Arm/Group Title	Water Control	Experimental Mouth Rinse	Positive Control	Total
Arm/Group Description	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.	Total of all reporting groups
Overall Participants	46	45	46	137
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.3 (11.83)	56.2 (14.97)	58.3 (12.04)	57.6 (12.95)
Sex: Female, Male (Count of Participants)
Female	39 84.8%	37 82.2%	37 80.4%	113 82.5%
Male	7 15.2%	8 17.8%	9 19.6%	24 17.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.2%	1 2.2%	0 0%	2 1.5%
Not Hispanic or Latino	45 97.8%	44 97.8%	46 100%	135 98.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.2%	0 0%	0 0%	1 0.7%
Asian	1 2.2%	0 0%	0 0%	1 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	3 6.5%	7 15.6%	12 26.1%	22 16.1%
White	41 89.1%	38 84.4%	33 71.7%	112 81.8%
More than one race	0 0%	0 0%	1 2.2%	1 0.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Description	Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth
Time Frame	4-hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Water Control	Experimental Mouth Rinse	Positive Control
Arm/Group Description	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Measure Participants	46	45	46
Least Squares Mean (Standard Error) [score on a scale]	2.51 (0.158)	3.26 (0.160)	3.43 (0.158)

2. Primary Outcome

Title	Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Description	Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth
Time Frame	6-hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Water Control	Experimental Mouth Rinse	Positive Control
Arm/Group Description	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Measure Participants	46	45	46
Least Squares Mean (Standard Error) [score on a scale]	2.70 (0.154)	3.46 (0.156)	3.36 (0.154)

Adverse Events

Time Frame	Products were used over 8 days
Adverse Event Reporting Description	investigator/examiner observed
Arm/Group Title	Water Control		Experimental Mouth Rinse		Positive Control
Arm/Group Description	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
All Cause Mortality
	Water Control		Experimental Mouth Rinse		Positive Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/45 (0%)		0/46 (0%)
Serious Adverse Events
	Water Control		Experimental Mouth Rinse		Positive Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/45 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Water Control		Experimental Mouth Rinse		Positive Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/46 (6.5%)		2/45 (4.4%)		2/46 (4.3%)
Gastrointestinal disorders
Aphthous Stomatitis	0/46 (0%)	0	0/45 (0%)	0	1/46 (2.2%)	2
Injury, poisoning and procedural complications
mouth injury	3/46 (6.5%)	3	2/45 (4.4%)	2	1/46 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI agreed to not publish results without prior written consent of Sponsor.