Xylitol Disk Use in Adults With Dry Mouth

Not Applicable

Completed

• Conditions: Mutans Streptococci; Xerostomia
• Interventions: Other: Xylitol disk

• Registration Number: NCT01823445
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-01
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xylitol disk	Xylitol disk	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.

Primary Outcome Measures

Name	Time	Method
Mutans streptococci levels	Two weeks	Change in mutans streptococci levels from Baseline to two weeks.

Secondary Outcome Measures

Name	Time	Method
GRIX measure of xerostomia	Two weeks	Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.

Trial Locations

Locations (1)

University of Washington, School of Dentistry, Regional Clinical Dental Research Center; 🇺🇸 Seattle, Washington, United States