Xylitol Disk Use in Adults With Dry Mouth

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.

Detailed Description
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Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci. The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.

Official Title
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XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth

Conditions
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Xerostomia, Mutans Streptococci

Intervention / Treatment
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* Other: Xylitol disk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 21 years old or older Daily use of at least 2 prescription medications known to cause dry mouth Current report of dry mouth Exclusion Criteria: Antibiotic use in the last month Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month Change in medication or dose within the last month Use of mouthwash within the last week Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis History of gastrointestinal disease

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol disk<br>Daily use of 8 disks containing 0.5 grams xylitol each for two weeks. The disks adhere to gum tissue with a food grade adhesive backing and slowly dissolve. The disks are applied one on each side of the mouth in the morning after breakfast, again at midday, and four are applied, two on each side, at bedtime. | Other: Xylitol disk<br> <br> * Other names: XyliMelts;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutans streptococci levels | Change in mutans streptococci levels from Baseline to one week. | One week | 
| Mutans streptococci levels | Change in mutans streptococci levels from Baseline to two weeks. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRIX measure of xerostomia | Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week. | One week | 
| GRIX measure of xerostomia | Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks. | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylitol, Dental caries