Clinical trial NCT00066053: Periodontitis and Cardiovascular Events or "PAVE"
Official title: Periodontal Intervention for Cardiac Events: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Coronary Heart Disease
Myocardial Infarction
Cerebrovascular Accident
Keywords: Heart attacks
Stroke
Angina
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2003-08-05
Enrollment: 303
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Sara G Grossi, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Goldman School of Dental Medicine, Boston, MA
name: Thomas E van Dyke, DDS,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Dept. of Periodontics, Baltimore, MD
name: John C Gunsolley, DDS,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of NC, School of Dentistry, Chapel Hill, NC
name: James D Beck, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of NC, Dept. of Biostatistics, Chapel Hill, NC
name: Lloyd E Chambless, PhD,
role: PRINCIPAL_INVESTIGATOR
affiliation: University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NC
name: Steven Offenbacher, DDS,PhD,MMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University, Portland, OR
name: Theresa Madden, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser-Permanente Center for Health Research, Portland, OR
name: Gerardo Maupome, PhD
role: PRINCIPAL_INVESTIGATOR
References: