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Completed

NCT Number: NCT01823445

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington, School of Dentistry, Regional Clinical Dental Research Center

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylitol disk

Other

Other names: XyliMelts

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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