Periodontitis and Cardiovascular Events or "PAVE"

University at Buffalo

Status: Completed

Conditions: Cerebrovascular Accident; Coronary Heart Disease; Myocardial Infarction; Cardiovascular Disease

Treatments: Procedure: Periodontal Treatment: SRP; Procedure: Referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00066053

NIDCR-13940

U01DE013940 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 303 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Periodontal Treatment: SRP

Experimental group

Description:

Comprehensive scaling \& root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions.

Treatment:

Procedure: Periodontal Treatment: SRP

Community Comparator

Active Comparator group

Description:

Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment.

Treatment:

Procedure: Referral