Xylitol Adult Caries Trial (X-ACT)

University of North Carolina (UNC)

Status and phase: Completed; Phase 3

Conditions: Dental Caries

Treatments: Dietary Supplement: xylitol; Dietary Supplement: inactive lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00393055

U01DE018038 (U.S. NIH Grant/Contract)

NIDCR-18038

Details and patient eligibility

About

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).

Full 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.

Enrollment: 709 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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709 participants in 2 patient groups, including a placebo group

xylitol lozenge

Experimental group

Description:

1g xylitol lozenge. Five/day, dissolved in mouth

Treatment:

Dietary Supplement: xylitol

inactive lozenge

Placebo Comparator group

Description:

1g placebo lozenge. Five/day, dissolved in mouth

Treatment:

Dietary Supplement: inactive lozenge