An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms

Solventum US LLC1 site in 1 country40 target enrollmentNovember 2, 2019

ConditionsXerostomia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Xerostomia
Sponsor: Solventum US LLC
Enrollment: 40
Locations: 1
Primary Endpoint: 10 cm Mouth Dryness Visual Analog Score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.

Detailed Description

The purpose of this study is to investigate the efficacy of 3M Dry Mouth Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 days of use. In addition, this study aims to support comparative claims.

Registry

clinicaltrials.gov

Start Date

November 2, 2019

End Date

December 13, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Solventum US LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Screening - Start of Wash-In Visit
•Subject who is ≥18 years of age and complains of dry mouth
•Only 1 subject per household is allowed into study
•Subject with a Challacombe scale score of 1 or higher
•Subject agrees to refrain from eating spicy foods and foods containing garlic beginning 48-hours prior to all study visits
•Subject agrees to eat a meal prior to all study visits that include sample evaluation in the clinic
•Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss teeth for 2-hours prior to sample evaluation study visits
•Subject agree to not use any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
•Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
•Subject agrees to only use those clinical oral care supplies provided during the entire study

Exclusion Criteria

•Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)
•Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores)
•Subject has a life-threatening pathological condition
•Subject is participating in another clinical trial at the time of the study
•Subject has profound marginal periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
•Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
•Difficult to be compliant with recalls, such as extensive travel commitments, lack of transportation etc.

Outcomes

Primary Outcomes

10 cm Mouth Dryness Visual Analog Score

Time Frame: 15 minutes post dose

Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.