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Xylitol Adult Caries Trial (X-ACT)

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT00393055
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
709
Enrollment
3
Locations
2
Arms
53
Duration (Months)
236.3
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: xylitol
  • Dietary Supplement: inactive lozenge
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
709 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Xylitol Adult Caries Trial (X-ACT)
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. combined root and coronal D2FS (dental caries) increment [3 year]

    Secondary Outcome Measures

    1. combined root and coronal D12FS (dental caries) increment [three year]

    2. separate root and coronal D12FS (dental caries) increments [3 years]

    3. association of lozenge use with D12FS (dental caries) in control group only [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294-0111
    2 University of North Carolina School of Dentistry Chapel Hill, North Carolina United States 27599-7450
    3 University of Texas Health Science Center San Antonio Texas United States 78229-3900

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • National Institute of Dental and Craniofacial Research (NIDCR)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jim Bader, DDS, Res Prof, University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT00393055
    Other Study ID Numbers:
    • NIDCR-18038
    • U01DE018038
    First Posted:
    Oct 26, 2006
    Last Update Posted:
    Sep 12, 2011
    Last Verified:
    Sep 1, 2011
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Sep 12, 2011