NCT04189081

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

A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	dry mouth rinse	relieves dry mouth symptoms by physically coating oral mucosal surfaces.
OTHER	Water Control	negative control

Timeline

• Start date: 2020-05-13
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2019-12-06
• Last updated: 2021-05-28
• Results posted: 2021-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study