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Periodontitis and Cardiovascular Events or "PAVE"
This study is ongoing, but not recruiting participants.
First Received: August 1, 2003   Last Updated: May 22, 2007   History of Changes
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00066053
  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 Intervention Phase
Cardiovascular Disease
Coronary Heart Disease
Myocardial Infarction
Cerebrovascular Accident
Procedure: Treatment of periodontal infections (gum problems)
Phase II

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

Resource links provided by NLM:


Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Patient outcomes are hospitalized myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and hospitalized ischemic stroke.

Estimated Enrollment: 400
Study Start Date: January 2003
Estimated Study Completion Date: May 2007
Detailed Description:

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
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066053

Locations
United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
Investigators
Principal Investigator: Sara Grossi, DDS, MS University of 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
  More Information

No publications provided

Study ID Numbers: NIDCR-13940
Study First Received: August 1, 2003
Last Updated: May 22, 2007
ClinicalTrials.gov Identifier: NCT00066053     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Heart attacks
Stroke
Angina

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Ischemia
Brain Diseases
Cerebrovascular Disorders
Coronary Disease
Necrosis
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009