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

Further Study Details: 

Expected Total Enrollment:  400

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

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

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.

New York
      University at Buffalo, Buffalo,  New York,  14214,  United States; Recruiting

Study chairs or principal investigators

Sara Grossi, DDS, MS,  Principal Investigator,  University of Buffalo   
Thomas E van Dyke, DDS,MS,  Principal Investigator,  Goldman School of Dental Medicine, Boston, MA   
John C Gunsolley, DDS,MS,  Principal Investigator,  University of Maryland, Dept. of Periodontics, Baltimore, MD   
James D Beck, Ph.D,  Principal Investigator,  University of NC, School of Dentistry, Chapel Hill, NC   
Lloyd E Chambless, PhD,,  Principal Investigator,  University of NC, Dept. of Biostatistics, Chapel Hill, NC   
Steven Offenbacher, DDS,PhD,MMSc,  Principal Investigator,  University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NC   
Theresa Madden, DDS, PhD,  Principal Investigator,  Oregon Health and Science University, Portland, OR   
Gerardo Maupome, PhD,  Principal Investigator,  Kaiser-Permanente Center for Health Research, Portland, OR   

Study ID Numbers:  NIDCR-13940
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 1, 2003
ClinicalTrials.gov Identifier:  NCT00066053
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08