Diabetes and Periodontics Trial R21

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DESCRIPTION (provided by applicant): Obesity and type 2 diabetes are emerging public health concerns in the United States. In 2002, the American Diabetes Association estimated that direct expenditures for diabetes care in the United States were 132 billion dollars. Glycemic control is essential to the prevention of diabetes-related morbidity and mortality, yet is difficult to achieve for many patients. Poor glycemic control is associated with chronic periodontitis and preliminary evidence suggests that periodontal treatment improves glycemic control. Results from our pilot study a double-blind, placebo-controlled, randomized clinical trial, which has been corroborated by others, suggest that non-surgical periodontal therapy may reduce HbA1c levels in individuals with type 2 diabetes. Also, a regimen of extracting hopeless teeth, and frequent supportive periodontal therapy, appears to improve the metabolic management of type 2 diabetes. To date there has been no adequately powered clinical trial to address this question. This application describes a planning grant to design a randomized, multi-center clinical trial of sufficient sample size that will test if periodontal therapy plays a meaningful role in diabetes care. The aims of the proposed clinical trial will be to test whether periodontal treatment is effective in improving the metabolic management of patients with type 2 diabetes and untreated periodontitis. The clinical trial will enroll 560 adults with type 2 diabetes and untreated periodontitis. Volunteers will be recruited from six geographically and ethnically diverse populations; New York City, NY, Stony Brook, NY, Birmingham, Alabama, Philadelphia, Pennsylvania, San Antonio, Texas, and Minneapolis, Minnesota. Subjects will have their dental caries restored, and hopeless teeth extracted prior to randomization. Subjects will be randomly assigned to receive immediate scaling and root planing (Test group, n=280) or, delayed scaling and root planing, (Control group, n=280). Rescue therapy will be provided for all subjects who experience progressive periodontitis. Medical treatment and medications will be closely monitored during the study. Subjects will be followed for six months. The primary outcome variable will be glycated hemoglobin (HbA1c). Secondary outcomes will be periodontal clinical measures and systemic markers of inflammation. The aims of this planning grant are to develop the protocol for the proposed clinical trial. During the proposed one-year planning period, a manual of procedures will be developed, that describes an administrative structure, scientific rationale and detailed protocol to carry out a phase 3 clinical trial. If this study demonstrates that periodontal therapy leads to improved glycemic control, the public health benefit in terms of reduced morbidity from this relatively modest treatment could be substantial.