verbatim) This proposal is to develop the clinical trial organization for studies of periodontal treatment in the secondary prevention of cardiovascular events and to develop the institutional teams to accomplish the research. With the appropriate infrastructure and procedures developed, a future definitive randomized clinical trial of the relationship between periodontal infection and cardiovascular disease can be successfully carried out. There is growing evidence of a strong relationship between infection and atherosclerosis as well as a specific link between periodontal infection and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to a diminution of subsequent occurrence of myocardial events in persons at high risk for cardiovascular disease. A clinical trial process to demonstrate the feasibility of a periodontal intervention trial in heart patients requires the establishment of a new team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers. In addition, such a study requires a large number of institutional investigative centers. In contrast to previous heart disease studies, the primary treatment in the new trial process would be directed toward infectious agents with specific attention to periodontal sites. We propose a multi-center Planning and Pilot Study involving 5 Investigational Centers at the University of Buffalo, University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a Coordinating Center at the University of North Carolina. This study will be supported by Central Microbiology and Cytokine Labs, and a Biologic Specimen Bank. The establishment of the investigative machinery to determine the relationships and treatments linking infection, periodontal disease and heart disease requires a careful, cost-effective approach. This planning proposal outlines a process designed to develop and demonstrate the procedures for such studies, to conduct a pilot randomized clinical trial to test the feasibility of these procedures, and to select and refine a periodontal intervention. We propose that this planning and pilot study will ultimately lead to a definitive randomized clinical trial of the relationship between periodontal infection and cardiovascular disease, and may be a vanguard study for such a trial.
