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Xylitol Adult Caries Trial (X-ACT)

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ClinicalTrials.gov Identifier: NCT00393055
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Jim Bader, DDS, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 25, 2006
First Posted Date  ICMJE October 26, 2006
Last Update Posted Date September 12, 2011
Study Start Date  ICMJE January 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2009)
combined root and coronal D2FS (dental caries) increment [ Time Frame: 3 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
dental caries increment
Change History Complete list of historical versions of study NCT00393055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2009)
  • combined root and coronal D12FS (dental caries) increment [ Time Frame: three year ]
  • separate root and coronal D12FS (dental caries) increments [ Time Frame: 3 years ]
  • association of lozenge use with D12FS (dental caries) in control group only [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xylitol Adult Caries Trial (X-ACT)
Official Title  ICMJE Xylitol Adult Caries Trial (X-ACT)
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Dietary Supplement: xylitol
    1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years
  • Dietary Supplement: inactive lozenge
    1g inactive lozenge, dissolved in mouth. Five/day for three years
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: xylitol lozenge
    1g xylitol lozenge. Five/day, dissolved in mouth
    Intervention: Dietary Supplement: xylitol
  • Placebo Comparator: inactive lozenge
    1g placebo lozenge. Five/day, dissolved in mouth
    Intervention: Dietary Supplement: inactive lozenge
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2009)
709
Original Enrollment  ICMJE
 (submitted: October 25, 2006)
750
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393055
Other Study ID Numbers  ICMJE NIDCR-18038
U01DE018038 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jim Bader, DDS, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: James D Bader, DDS MPH UNC School of Dentistry
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP