Completed

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

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What is being tested

Marketed Dry Mouth Rinse

+ Water control
+ Experimental Dry Mouth Rinse
Device
Other
Who is being recruted

Dry Mouth

Over 18 Years
+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: November 2019

See protocol details

Summary

Principal SponsorProcter and Gamble
Last updated: February 2, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: November 4, 2019Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control 
Principal SponsorProcter and Gamble
Last updated: February 2, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
22 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Dry Mouth
Criteria
9 inclusion criteria required to participate
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

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14 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
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.
Group II
Experimental
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.
Group III
Sham
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.
Study Objectives
Primary Objectives

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Procter & GambleMason, United StatesSee the location
CompletedOne Study Center