Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-02

Study Completion Date

2019-12-13

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.

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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.

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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3M Dry Mouth Moisturizing Spray

Dry mouth agent

Group Type EXPERIMENTAL

3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray

Intervention Type DEVICE

20 ml bottle

Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Intervention Type DEVICE

44.3 ml bottle

Biotene Moisturizing Mouth Spray

Dry mouth agent

Group Type ACTIVE_COMPARATOR

3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray

Intervention Type DEVICE

20 ml bottle

Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Intervention Type DEVICE

44.3 ml bottle

Interventions

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3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray

20 ml bottle

Intervention Type DEVICE

Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

44.3 ml bottle

Intervention Type DEVICE

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No