Prevention of Adult Caries Study (PACS) Tuba City Clinical Center

Project: Research project

Description

DESCRIPTION (provided by applicant): 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 exacts 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 FDA 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 different populations. The primary endpoint for this study will be caries increment. The centers participating in this proposed research are: Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Dental Service of Massachusetts Clinical Center 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. This application from the Tuba City Clinical Center is part of the coordinated set of applications in support of the PACS study. Please refer to the Administrative Center Application for a complete description of the study Protocol and Manual of Procedures.
StatusFinished
Effective start/end date8/15/065/31/11

Funding

  • National Institutes of Health: $58,646.00
  • National Institutes of Health: $19,679.00
  • National Institutes of Health: $459,477.00

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Tooth
Dental Clinics
Root Caries
Economics
Research
Investigational Drugs
Phase III Clinical Trials
Chlorhexidine
Controlled Clinical Trials
Health
Dental Caries
Licensure
Communicable Diseases
Chronic Disease
Placebos
Delivery of Health Care
Population
Therapeutics

ASJC

  • Medicine(all)
  • Dentistry(all)