Prevention of Adult Caries Study (PACS) - KP Portland Clinical Center
Project Number1U01DE017746-01
Contact PI/Project LeaderSNYDER, JOHN J
Awardee OrganizationKAISER FOUNDATION RESEARCH INSTITUTE
Description
Abstract Text
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 Kaiser Permanente Portland 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.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
clinical researchclinical trialscommunityexperiencehealthpreventionroletobaccouniversityurban area
National Institute of Dental and Craniofacial Research
CFDA Code
121
DUNS Number
150829349
UEI
P1RTMASB37B5
Project Start Date
15-August-2006
Project End Date
31-May-2010
Budget Start Date
15-August-2006
Budget End Date
31-May-2007
Project Funding Information for 2006
Total Funding
$886,096
Direct Costs
$560,820
Indirect Costs
$325,276
Year
Funding IC
FY Total Cost by IC
2006
National Institute of Dental and Craniofacial Research
$886,096
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 1U01DE017746-01
Publications
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Clinical Studies
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