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Periodontitis and Cardiovascular Events or "PAVE"
This study is currently recruiting patients.
Sponsored by: | National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
Cardiovascular Disease Coronary Heart Disease Myocardial Infarction Cerebrovascular Accident |
Procedure: Treatment of periodontal infections (gum problems) |
Phase II |
MedlinePlus related topics: Circulatory Disorders; Coronary Disease; Heart Attack; Heart Diseases; Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title: Periodontal Intervention for Cardiac Events: A Pilot Trial
Expected Total Enrollment: 400
Study start: January 2003;
Study completion: June 2005
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
Eligibility
Ages Eligible for Study: up to 75 Years, Genders Eligible for Study: Both
Criteria
Eligibility:
Exclusion:
Any of the following:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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