Xylitol Disk Use in Adults With Dry Mouth

December 1, 2013 updated by: Peter Milgrom, University of Washington

XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington, School of Dentistry, Regional Clinical Dental Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • XyliMelts

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 1, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XM2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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