Xylitol Disk Use in Adults With Dry Mouth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Milgrom, University of Washington
ClinicalTrials.gov Identifier:
NCT01823445
First received: March 27, 2013
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Mutans Streptococci
Xerostomia
Other: Xylitol disk

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823445

Locations
United States, Washington
University of Washington, School of Dentistry, Regional Clinical Dental Research Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Peter Milgrom, DDS University of Washington
  More Information

No publications provided

Responsible Party: Peter Milgrom, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01823445     History of Changes
Other Study ID Numbers: XM2013
Study First Received: March 27, 2013
Last Updated: December 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Xylitol
Dental caries

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014