Xylitol Adult Caries Trial (X-ACT)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Dietary Supplement: xylitol Dietary Supplement: inactive lozenge |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Xylitol Adult Caries Trial (X-ACT) |
- combined root and coronal D2FS (dental caries) increment [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- combined root and coronal D12FS (dental caries) increment [ Time Frame: three year ] [ Designated as safety issue: No ]
- separate root and coronal D12FS (dental caries) increments [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- association of lozenge use with D12FS (dental caries) in control group only [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 709 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: xylitol
|
|
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 Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-0111 | |
| United States, North Carolina | |
| University of North Carolina School of Dentistry | |
| Chapel Hill,, North Carolina, United States, 27599-7450 | |
| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229-3900 | |
| Principal Investigator: | James D Bader, DDS MPH | UNC School of Dentistry |
More Information
No publications provided by University of North Carolina, Chapel Hill
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jim Bader, DDS, Res Prof, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00393055 History of Changes |
| Other Study ID Numbers: | NIDCR-18038, U01DE018038 |
| Study First Received: | October 25, 2006 |
| Last Updated: | September 9, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013