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

• 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: Procter and Gamble
• Information provided by (Responsible Party): Procter and Gamble

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	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 3-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: November 4, 2019
• Actual Primary Completion Date: December 5, 2019
• Actual Study Completion Date: December 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, Ohio

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)

Documents provided by Procter and Gamble:

Study Protocol and Statistical Analysis Plan  [PDF] October 10, 2019

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT04152642
• Other Study ID Numbers: CSD2019138
• First Posted: November 5, 2019
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Last Verified: January 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; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases