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

A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control

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.

Study Overview

• Status: Completed
• Conditions: Dry Mouth
• Intervention / Treatment: Device: Marketed Dry Mouth Rinse; Device: Experimental Dry Mouth Rinse; Other: Water control

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Mason, Ohio, United States, 45040
      • Procter & Gamble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Performance and Attributes (PPAQ I) Question #1: 2-hr at 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	2-hour, Day 4

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2019
• Primary Completion (ACTUAL): December 5, 2019
• Study Completion (ACTUAL): December 5, 2019

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: CSD2019138

Drug and device information, study documents

• 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