NCT04152642

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dry Mouth

Interventions

Type	Name	Description
DEVICE	Marketed Dry Mouth Rinse	relieves dry mouth symptoms by physically coating oral mucosal surfaces.
OTHER	Water control	negative control
DEVICE	Experimental Dry Mouth Rinse	relieves dry mouth symptoms by physically coating oral mucosal surfaces.

Timeline

• Start date: 2019-11-04
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2019-11-05
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study