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.
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
- Periodontal Treatment: SRP Procedure
Other Names: Treatment of periodontal infections. Intervention Desc: Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions. ARM 1: Kind: Experimental Label: Periodontal Treatment: SRP Description: Comprehensive scaling & root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions.
- Referral Procedure
ARM 1: Kind: Experimental Label: Community Comparator Description: Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||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|