There is compelling epidemiological and clinical evidence to suggest that periodontal infection adversely affects glycemic control in people with type 2 diabetes mellitus. The purpose of this project is to establish important preliminary data necessary to support design of a randomized clinical trail (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 involving treating periodontal infection to obtain estimates of changes and variablility of those changes in the established primary endpoint, hemoglobin A1c (HbA1c). This project will also provide an opportunity to explore use of several potential secondary endpoints including levels of periodontitis- and glucose metabolism-related inflammatory mediators (TNFalphA,IL-1b, IL-6) and levels of serum cholesterol, triglyceride and lipids in patients with type 2 diabetes mellitus. The periodontal therapeutic regimen that will be evaluated will include ultrasonic bacterial curettage, local antimicrobial treatment with povidone-iodine irrigation, and oral systemic antibiotics (doxycycline or metronidizole). Prior to beginning the pilot treatment phase, we will characterize potentially eligible patients with type 2 diabetes who are registered in diabetes patient databases in the U-M Hospital and M-CARE (the U of M sponsored HMO) for inclusion in a sampling frame of 1,000 individuals that will be used to select and recruit subject for treatment of periodontal infection. Eligible and will subject will be identified and characterisized from this sample of 1000 via a detailed telephone interview. A sample of 135 of the telephone survey participants will participate in a screening examination session to identify 45 subject for the periodontal therapy phase. These subject will be treated and followed for 15 months. Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIH/NIDCR for funding an RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIH/NIDCR for funding an RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes. If results from the full scale clinical trail provide evidence that treating periodontal infection contributes to improved glycemic control, then diagnosis and treatment of periodontal infection in subject with NIDDM could be substantiated as an important component in management of NIDDM.
