Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

This is an interventional treatment trial for Xerostomia Read More

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.