Periodontitis and Cardiovascular Events or "PAVE"

Myocardial Infarction Clinical Trial

Official title:

Periodontal Intervention for Cardiac Events: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066053
• Other study ID #: NIDCR-13940
• Secondary ID: U01DE013940
• Status: Completed
• Phase: N/A
• First received: August 1, 2003
• Last updated: August 4, 2011
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: May 2007
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Stroke

Intervention

Procedure:
• Periodontal Treatment: SRP
Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
• Referral

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke.		One year	Yes