Overview

This trial is active, not recruiting.

Condition caries.
Treatment 10% w/v chlorhexidine acetate coating fda ind #45466
Phase phase 3
Sponsor Tufts University
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date July 2006
End date August 2009
Trial size 983 participants
Trial identifier NCT00357877, DE017753-01, U01DE017753

Summary

Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife with an ever growing economic toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved anti-microbial treatment for decay is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reduce new decay in adult dental patients at risk for decay.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Dental coating with all ingredients except chlorhexidine applied by dental professional supragingivally to the full dentition
10% w/v chlorhexidine acetate coating fda ind #45466
dental coating topical applied by dental professional supragingivally to the full dentition

Primary Outcomes

Measure
The primary outcome variable
time frame: (V1) to the 13 month follow-up visit

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years of age and older - at least 20 intact natural teeth, excluding third molars - 2 or more lesions, of which at least one must be a cavitated D2 or D3 - willing and able to provide informed consent Exclusion Criteria - pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted) - use of fixed orthodontic appliances - allergic to any of the ingredients of the study medication - long-term antibiotic therapy - a history of, or currently active, radiation therapy for cancers of the head or neck - Sjögren's syndrome - advanced periodontitis - consumption of the equivalent of more than five servings of acidic or sugared drinks per day - having 10 or more lesions requiring restorative care at the time of the screening visit - remineralization therapy within one month of randomization - investigator discretion

Additional Information

Official title Prevention of Adult Caries Study
Principal investigator Athena Papas, PhD DMD
Description Adult dental caries, including both coronal and root caries, is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife. In addition, adult caries wreaks a significant economic toll, and this economic toll continues to grow. Despite the high prevalence and bacterial pathogenesis of caries, no FDA-approved anti-microbial treatment for caries is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under F.D.A. Investigational New Drug license #45,466. This study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing caries increment in at-risk adult dental patients. This study will follow 1000 patients over a 13-month study period at four centers with vastly diffent populations. The primary endpoint for this study will be caries increment. The centers participating in this proposed reaserch are: Kaiser Permanente's Dental Plan in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Delta Dental Massachusetts' Dental Clinic in Southborough, Massachusetts; and the dental clinic of the Tuba City Regional Health Care Corporation in Tuba City, Arizona. Kaiser Permanente's Center for Health Research in Portland, Oregon will act as the data-coordinating center, and Tufts University will act as the Administrative Center.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Tufts University.