Xylitol Disk Use in Adults With Dry Mouth
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth|
- Mutans streptococci levels [ Time Frame: One week ] [ Designated as safety issue: No ]Change in mutans streptococci levels from Baseline to one week.
- Mutans streptococci levels [ Time Frame: Two weeks ] [ Designated as safety issue: No ]Change in mutans streptococci levels from Baseline to two weeks.
- GRIX measure of xerostomia [ Time Frame: One week ] [ Designated as safety issue: No ]Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week.
- GRIX measure of xerostomia [ Time Frame: Two weeks ] [ Designated as safety issue: No ]Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.
|Study Start Date:||March 2013|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: Xylitol disk
Other Name: XyliMelts
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823445
|United States, Washington|
|University of Washington, School of Dentistry, Regional Clinical Dental Research Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Peter Milgrom, DDS||University of Washington|