Xylitol Disk Use in Adults With Dry Mouth
Primary Purpose
Mutans Streptococci, Xerostomia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xylitol disk
Sponsored by
About this trial
This is an interventional prevention trial for Mutans Streptococci focused on measuring Xylitol, Dental caries
Eligibility Criteria
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
Sites / Locations
- University of Washington, School of Dentistry, Regional Clinical Dental Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xylitol disk
Arm Description
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.
Outcomes
Primary Outcome Measures
Mutans streptococci levels
Change in mutans streptococci levels from Baseline to one week.
Mutans streptococci levels
Change in mutans streptococci levels from Baseline to two weeks.
Secondary Outcome Measures
GRIX measure of xerostomia
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to 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.
Full Information
NCT ID
NCT01823445
First Posted
March 27, 2013
Last Updated
December 1, 2013
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT01823445
Brief Title
Xylitol Disk Use in Adults With Dry Mouth
Official Title
XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mutans Streptococci, Xerostomia
Keywords
Xylitol, Dental caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xylitol disk
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Xylitol disk
Other Intervention Name(s)
XyliMelts
Primary Outcome Measure Information:
Title
Mutans streptococci levels
Description
Change in mutans streptococci levels from Baseline to one week.
Time Frame
One week
Title
Mutans streptococci levels
Description
Change in mutans streptococci levels from Baseline to two weeks.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
GRIX measure of xerostomia
Description
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week.
Time Frame
One week
Title
GRIX measure of xerostomia
Description
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Milgrom, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, School of Dentistry, Regional Clinical Dental Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Xylitol Disk Use in Adults With Dry Mouth
We'll reach out to this number within 24 hrs