Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Not Applicable

Completed

Conditions: Xerostomia

Interventions: Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray
Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Registration Number: NCT04186806

Lead Sponsor: Solventum US LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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
Able to understand and willing to sign the Informed Consent Form

Water Only Evaluation Visit

Subject has successfully completed a ≥ 2-day wash-in period
Subject has Challacombe scale score of 1 or higher
Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to the sample evaluation visits
Subject ate a meal prior to sample evaluation study visits
Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
Subject has not used any oral care products, 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 has used only those clinical oral care supplies provided during study

Baseline Period 1/Randomization Visit

Subject has successfully completed a ≥ 2-day wash-in period
Subject has a Challacombe Scale score of 1 or higher
Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to sample evaluation study visits
Subject ate a meal prior to sample evaluation study visits
Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
Subject has not used 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 has used only those clinical oral care supplies provided during 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3M Dry Mouth Moisturizing Spray	Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray	Dry mouth agent
3M Dry Mouth Moisturizing Spray	3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray	Dry mouth agent
Biotene Moisturizing Mouth Spray	Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray	Dry mouth agent
Biotene Moisturizing Mouth Spray	3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray	Dry mouth agent

Primary Outcome Measures

Name	Time	Method
10 cm Mouth Dryness Visual Analog Score	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.

Secondary Outcome Measures

Name	Time	Method
10 cm Mouth Dryness Visual Analog Score	120 minutes	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
10 cm Mouth Dryness Visual Analog Scale	30 minutes	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
Response to Soothing in the Mouth	240 minutes	5 point ordinal scale 1 = Poor and 5 = Excellent
Response on Dry Mouth Relief	240 minutes	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
10 cm Mean Mouth Dryness Visual Analog Score	5 minutes	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
10 cm Mean Mouth Dryness Visual Analog Scale	120 minutes	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Response to Effectively Moistens the Mouth	240 minutes	5 point ordinal scale 1 = Poor and 5 = Excellent
Response to Effectively Lubricates the Mouth	240 minutes	5 point ordinal scale 1 = Poor and 5 = Excellent
Response to Feel Comfortable in the Mouth	240 minutes	5 point ordinal scale 1 = Poor and 5 = Excellent