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Xylitol Disk Use in Adults With Dry Mouth

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ClinicalTrials.gov Identifier: NCT01823445
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Milgrom, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mutans Streptococci Xerostomia Other: Xylitol disk Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
Drug Information available for: Xylitol

Arms and Interventions
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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 Name: XyliMelts


Outcome Measures
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Primary Outcome Measures :
  1. Mutans streptococci levels [ Time Frame: One week ]
    Change in mutans streptococci levels from Baseline to one week.

  2. Mutans streptococci levels [ Time Frame: Two weeks ]
    Change in mutans streptococci levels from Baseline to two weeks.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823445


Locations
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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
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Principal Investigator: Peter Milgrom, DDS University of Washington
More Information
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Responsible Party: Peter Milgrom, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01823445    
Other Study ID Numbers: XM2013
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013
Keywords provided by Peter Milgrom, University of Washington:
Xylitol
Dental caries
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases