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Periodontitis and Cardiovascular Events or "PAVE"



Periodontitis and Cardiovascular Events or "PAVE"

For Condition: Myocardial Infarction,Cardiovascular Disease,Cerebrovascular Accident,Coronary Heart Disease
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: Eligibility: - Aged 75 years or less AND 50% or more blockage of at least one artery in the heart, - Heart problems in the last 3 years (including previous heart attack), - Previous heart bypass surgery, or previous heart angioplasty with or without a stent, AND at least 6 natural teeth present in the mouth AND evidence of mild to severe gum problems. Exclusion: Any of the following: - A major illness requiring hospitalization, - Renal dialysis, - Serum creatinine > 3 mg/dl, - Organ transplant recipient requiring immunosuppression medication, - Surgery needed in the next 3 years, - Chemotherapy in the past 3 years, - Head and/or neck radiation at any time in the past, - Liver dysfunction, - Class IV congestive heart failure, - Drug or alcohol abuse, - Pacemaker or AICD/defibrillator.
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
JamesBeck,  Principal Investigator,  University of NC, School of Dentistry, Chapel Hill, NC

University at Buffalo *Recruiting*
Buffalo,  New York,  14214
United States
Recruiting Robert  Genco 716-829-2854


Additional Information:
Study ID Numbers:
  NIDCR-13940; 
Study Start Date: January 2003
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066053

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