CLINICAL DIRECTORS NETWORK, INC.
UNIVERSITY OF MICHIGAN

Treating Periodontal Infection: Effects On Glycemic Control in Community Health Centers

Project Background and Goals:

This two-year pilot project, funded by the National Institute of Dental and Craniofacial Research, will establish important preliminary data necessary to support design of a multi-center randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. A total of 200 patients will be sampled for eligibility determination and recruitment for participation in a screening visit and the full-scale RCT, as well as to test the effectiveness of different methods of contacting them.

To accomplish this goal, this pilot study will demonstrate the feasibility of conducting such a trial in Federally Qualified Health Centers (FQHC’s) that are part of the Clinical Directors Network (CDN). The specific aims are to (1) identify and characterize potentially eligible patients with type 2 diabetes who are listed in a diabetes registry within the FQHC’s and to review the clinical and administrative electronic databases and medical records to characterize the potential participants with respect to study eligibility criteria to prepare a sampling frame for a pilot screening visit; (2) construct a stratified probability sample of 200 potential participants from the patients in the diabetes registries; (3) test the effectiveness of different methods of contacting the 200 sampled patients for eligibility determination and recruitment for participation in a screening visit and the full-scale RCT; (4) determine the proportion of 50 patients per FQHC sampled from the 200 (selected in Aim 2) who present for the pilot screening visit after being scheduled; (5) conduct the pilot screening visit, consisting of a brief physical examination, hemoglobin A1c measurement, a face-to-face interview, and a periodontal examination to characterize the patients who present with regards to important RCT-related planning characteristics including prevalence of periodontal disease, other RCT eligibility criteria, and willingness to participate in a full-scale RCT; (6) establish estimates of number of patients and clinics necessary for conducting the multi-center RCT; and (7) assess the association between periodontal infection and poor glycemic control in the participants of this pilot project. 

The outcome is to provide evidence that treating periodontal infection contributes to improved glycemic control through a yet-to-be planned full-scale RCT.

Interventions that are effective in improving glycemic control have been shown to reduce complications and, consequently, the burden of type 2 diabetes. The long-term goal of this project is to establish that treatment of periodontal infection could be substantiated as an important component in management of type 2 diabetes.

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