'Periodontal Intervention for Cardiac Events: Pilot Trial', is a feasibility study and pilot trial funded through the National Institute of Dental and Craniofacial Research (NIDCR). The overall goal is to produce a detailed clinical trial research plan with field-tested manual of operations and procedures for a full-scale definitive randomized clinical trial to determine whether treatment of periodontal disease will result in a reduction of secondary cardiovascular events.
The pilot trial will recruit patients over a 2 year period with documented heart disease and significant periodontal disease from 5 investigative centers in the U.S. Patients will be randomized to one of three treatment arms and be followed for a minimum of 6 months by the end of the 3-year study period. The pilot trial will be used to refine the infrastructure, and to select or refine an intervention protocol for the definitive trial, and may in fact serve as a vanguard phase for the definitive trial.
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