Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray
* Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All subjects completing the wash-in procedures and meeting inclusion/exclusion criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess the effect of water on their dry mouth symptoms. The subjects will return the next day for confirmation that inclusion/exclusion criteria and the wash-in procedures continue to be met or followed. Eligible subjects will be randomized at this baseline visit in a 1:1 ratio to one of two treatment orders: A->B (AB) or B->A (BA).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3M Dry Mouth Moisturizing Spray<br>Dry mouth agent | Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray<br>* 20 ml bottle<br>Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray<br>* 44.3 ml bottle<br>|
| Active Comparator: Biotene Moisturizing Mouth Spray<br>Dry mouth agent | Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray<br>* 20 ml bottle<br>Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray<br>* 44.3 ml bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 cm Mouth Dryness Visual Analog Score | 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. | 15 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 240 minutes post dose | 
| 10 cm Mouth Dryness Visual Analog Score | 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. | 240 minutes | 
| 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 5 minutes | 
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 30 minutes | 
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 60 minutes | 
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 120 minutes | 
| 10 cm Mouth Dryness Visual Analog Scale | 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. | 5 minutes | 
| 10 cm Mouth Dryness Visual Analog Scale | 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. | 15 minutes | 
| 10 cm Mouth Dryness Visual Analog Scale | 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. | 30 minutes | 
| 10 cm Mouth Dryness Visual Analog Score | 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. | 60 minutes | 
| 10 cm Mouth Dryness Visual Analog Score | 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. | 120 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 5 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 15 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 30 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 60 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 120 minutes | 
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 240 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes | 
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes | 
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes | 
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes | 
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes |