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

NCT ID: NCT04189081

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2020-07-08

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.

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).

Conditions

Dry Mouth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

dry mouth rinse

Intervention Type: DEVICE

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

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.

Group Type: SHAM_COMPARATOR

Water Control

Intervention Type: OTHER

negative control

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.

Group Type: ACTIVE_COMPARATOR

dry mouth rinse

Intervention Type: DEVICE

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Interventions

dry mouth rinse

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Intervention Type: DEVICE

Water Control

negative control

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Milleman, DDS

Role: PRINCIPAL_INVESTIGATOR

Procter and Gamble

Locations

Salus Research

Fort Wayne, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSD2019158

Identifier Type: -

Identifier Source: org_study_id