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Periodontitis and Cardiovascular Events or "PAVE"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00066053
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : August 5, 2011
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University at Buffalo

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Disease Coronary Heart Disease Myocardial Infarction Cerebrovascular Accident Procedure: Periodontal Treatment: SRP Procedure: Referral Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Periodontal Intervention for Cardiac Events: A Pilot Trial
Study Start Date : January 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Referral


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066053


Locations
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United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
University at Buffalo
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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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
More Information
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Responsible Party: Robert J. Genco, DDS, PhD, Distinguished Professor, Vice Provost, STOR, University at Buffalo
ClinicalTrials.gov Identifier: NCT00066053    
Other Study ID Numbers: NIDCR-13940
U01DE013940 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: May 2007
Keywords provided by University at Buffalo:
Heart attacks
Stroke
Angina
Additional relevant MeSH terms:
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Stroke
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Infarction
Ischemia
 Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases