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

NCT04189081 | Completed Results FDA Device

• 1 other identifier: CSD2019158
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Mouth

Outcome Measures

Primary Outcomes (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

  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

  4-hours

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

  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

  6-hours

Study Arms (3)

Experimental Mouth Rinse

EXPERIMENTAL

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

Water Control

SHAM COMPARATOR

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

Positive Control

ACTIVE COMPARATOR

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

Interventions

dry mouth rinse DEVICE

relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Experimental Mouth Rinse; Positive Control

Water Control OTHER

negative control

Water Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter & Gamble

combs.cs@pg.com

5136225362

Study Officials

• Jeff Milleman, DDS

  Procter and Gamble

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: May 13, 2020
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: May 28, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-05

Locations

US (1)