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Periodontitis and Cardiovascular Events or "PAVE"

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT00066053
First received: August 1, 2003
Last updated: August 4, 2011
Last verified: May 2007
  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
Cardiovascular Disease
Coronary Heart Disease
Myocardial Infarction
Cerebrovascular Accident
Procedure: Periodontal Treatment: SRP
Procedure: Referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Periodontal Intervention for Cardiac Events: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 303
Study Start Date: January 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University at Buffalo
Investigators
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

No publications provided

Responsible Party: Robert J. Genco, DDS, PhD, Distinguished Professor, Vice Provost, STOR, University at Buffalo
ClinicalTrials.gov Identifier: NCT00066053     History of Changes
Other Study ID Numbers: NIDCR-13940, U01DE013940
Study First Received: August 1, 2003
Last Updated: August 4, 2011
Health Authority: United States: Federal Government

Keywords provided by University at Buffalo:
Heart attacks
Stroke
Angina

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

ClinicalTrials.gov processed this record on November 25, 2014