Periodontitis and Cardiovascular Events or "PAVE"
The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease.
Coronary Heart Disease
Procedure: Periodontal Treatment: SRP
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Periodontal Intervention for Cardiac Events: A Pilot Trial|
- Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2003|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Experimental: Periodontal Treatment: SRP
Comprehensive scaling & root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions.
Procedure: Periodontal Treatment: SRP
Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
Other Name: Treatment of periodontal infections.
Active Comparator: Community Comparator
Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment.
There is growing evidence of a strong association between infection and atherosclerosis as well as a specific link between periodontal infection (gum problems) and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to fewer heart events in persons at high risk for cardiovascular disease. In contrast to previous heart disease studies, the primary treatment in this project is directed toward infectious agents at periodontal sites. This project is a pilot randomized clinical trial to test the feasibility of selecting and refining a periodontal infection treatment and examining the effect of that treatment on future heart events. It is a multi-center planning and pilot study involving five investigational centers at the University at Buffalo (lead and overall coordinating center), University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a data coordinating center at the University of North Carolina. Central microbiology and cytokine laboratories and a biologic specimen bank are also included. A team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers has been assembled to accomplish the research with a careful, cost-effective approach. The ultimate goal is to develop a definitive randomized clinical trial that will include about 4,000 participants from approximately 15 centers across the United States
|United States, New York|
|University at Buffalo|
|Buffalo, New York, United States, 14214|
|Principal Investigator:||Sara G Grossi, DDS, MS||University at Buffalo|
|Principal Investigator:||Thomas E van Dyke, DDS,MS||Goldman School of Dental Medicine, Boston, MA|
|Principal Investigator:||John C Gunsolley, DDS,MS||University of Maryland, Dept. of Periodontics, Baltimore, MD|
|Principal Investigator:||James D Beck, Ph.D||University of NC, School of Dentistry, Chapel Hill, NC|
|Principal Investigator:||Lloyd E Chambless, PhD,||University of NC, Dept. of Biostatistics, Chapel Hill, NC|
|Principal Investigator:||Steven Offenbacher, DDS,PhD,MMSc||University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NC|
|Principal Investigator:||Theresa Madden, DDS, PhD||Oregon Health and Science University, Portland, OR|
|Principal Investigator:||Gerardo Maupome, PhD||Kaiser-Permanente Center for Health Research, Portland, OR|