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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DE013940-03S1
Application #
6780109
Study Section
Special Emphasis Panel (ZDE1)
Program Officer
Mowery, Richard L
Project Start
2001-07-15
Project End
2004-06-30
Budget Start
2003-07-01
Budget End
2004-06-30
Support Year
3
Fiscal Year
2003
Total Cost
$9,326
Indirect Cost
Name
State University of New York at Buffalo
Department
Dentistry
Type
Schools of Dentistry
DUNS #
038633251
City
Buffalo
State
NY
Country
United States
Zip Code
14260
Hall, Lindsay M; Dunford, Robert G; Genco, Robert J et al. (2012) Levels of serum immunoglobulin G specific to bacterial surface protein A of Tannerella forsythia are related to periodontal status. J Periodontol 83:228-34
Offenbacher, Steven; Beck, James D; Moss, Kevin et al. (2009) Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease. J Periodontol 80:190-201
Beck, James D; Couper, David J; Falkner, Karen L et al. (2008) The Periodontitis and Vascular Events (PAVE) pilot study: adverse events. J Periodontol 79:90-6
Couper, David J; Beck, James D; Falkner, Karen L et al. (2008) The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls. J Periodontol 79:80-9
Genco, Robert J; Falkner, Karen L; Grossi, Sara et al. (2007) Validity of self-reported measures for surveillance of periodontal disease in two western New York population-based studies. J Periodontol 78:1439-54