Xylitol Adult Caries Trial (X-ACT)

September 9, 2011 updated by: Jim Bader, DDS, University of North Carolina, Chapel Hill
The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental caries incidence is higher in adults than children. Recent recommendations from both the Centers for Disease Control and an NIH Consensus Development Conference on dental caries call for clinical trials of caries prevention methods in caries-active adults. Little is known about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are at elevated risk for developing caries lesions. This application describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the CDC and Consensus Conference recommendations.

The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. The intervention is the daily use of xylitol lozenges. Participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of three Clinical Centers in Chapel Hill, NC, Birmingham, AL, and San Antonio TX. These Clinical Centers offer diverse populations with substantial proportions of minority populations that enhance the generalizability of the findings. The Study Chair is located at the University of North Carolina-Chapel Hill, and the Data Coordinating Center is at the Kaiser Permanente Center for Health Research in Portland, OR.

This intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their caries-active patients. The potential for adoption of the intervention is an important consideration because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. If effective, the intervention also holds potential as a public health measure.

Study Type

Interventional

Enrollment (Actual)

709

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35294-0111
        • University of Alabama at Birmingham
    • North Carolina
      • Chapel Hill,, North Carolina, United States, 27599-7450
        • University of North Carolina School of Dentistry
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science 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

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 25-80
  • at least one caries lesion in year prior to enrollment
  • at least 12 teeth without crowns
  • no allergies to xylitol or aspartame
  • anticipate remaining in area for 3 years

Exclusion Criteria:

  • 10 or more caries lesions in year prior to enrollment
  • currently receiving long-term antibiotic therapy
  • history of head and neck radiation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: xylitol lozenge
1g xylitol lozenge. Five/day, dissolved in mouth
Dietary supplement: xylitol
1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years
Placebo Comparator: inactive lozenge
1g placebo lozenge. Five/day, dissolved in mouth
Dietary supplement: inactive lozenge
1g inactive lozenge, dissolved in mouth. Five/day for three years
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined root and coronal D2FS (dental caries) increment
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
combined root and coronal D12FS (dental caries) increment
Time Frame: three year
three year
separate root and coronal D12FS (dental caries) increments
Time Frame: 3 years
3 years
association of lozenge use with D12FS (dental caries) in control group only
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: James D Bader, DDS MPH, UNC School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-18038
  • U01DE018038 (U.S. NIH Grant/Contract)

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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