Periodontitis and Cardiovascular Events or "PAVE"

August 4, 2011 updated by: University at Buffalo

Periodontal Intervention for Cardiac Events: A Pilot Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 1, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-13940
  • U01DE013940 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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