Compelling epidemiological and clinical evidence suggests that periodontal infection adversely affects glycemic control in people with type 2 diabetes. While encouraging results have been published, insufficient evidence exists to conclude treating periodontal infection consistently leads to improved glycemic control. This project's purpose is to establish important preliminary data necessary to support design of a multicenter randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. Accomplishing this goal will require conducting a pilot study to 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 A1 c 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. Both periodontal infection and diabetes are 2 common chronic diseases in the U.S. population with more prevalent and severe complications in populations like those served by FQHC's. Interventions that are effective in improving glycemic control have been shown to reduce complications and, consequently, the burden of type 2 diabetes. If results from the yet-to-be planned full-scale RCT provide evidence that treating periodontal infection contributes to improved glycemic control, then treatment of periodontal infection could be substantiated as an important component in management of type 2 diabetes. ? ?
