The Diabetes and Periodontal Therapy Trial (DPTT)

Objectives: Evidence suggests that periodontitis adversely affects glycemic control in patients with diabetes. The DPTT's purpose is to determine if non-surgical periodontal treatment reduces hemoglobin A1c (HbA1c) in subjects with type 2 diabetes and moderate or advanced periodontitis. Methods: DPTT is an ongoing, phase-III, multi-center, randomized trial with planned enrollment of 600 men and women with type 2 diabetes and concurrent chronic periodontitis. Enrollment began in November 2009 and will continue thru May 2012. Participants are recruited from diabetes clinics, dental clinics and communities at five sites in North America. Periodontal clinical parameters and HbA1c values are determined at baseline, 3 months and 6 months. Data on medication usage and dosing are collected at each visit. Treatment consists of scaling and root planing under local anesthetic for a minimum of two 90-minute sessions, plus chlorhexidine rinse (BID). Control participants receive the same treatment after 6 months (delayed therapy). The primary outcome is change in HbA1c values (%HbA1c) at 6 months. Secondary outcomes are changes in periodontal clinical measures (gingival index, bleeding on probing, pocket depths, and clinical attachment levels) and the Homeostasis Model Assessment (HOMA2). Results: Through September 2011, over 1,400 potential subjects were screened, and 369 subjects randomized. Mean (SD) baseline hemoglobin A1c values to date are 7.8% (0.6). Fewer than 10% of subjects enrolled have been lost to follow up. Conclusion: The increasing diabetes burden necessitates exploring new therapies and ways to manage this disease. The DPTT is an ongoing clinical trial in which dental and medical researchers have successfully collaborated to recruit subjects with both medical and dental entry criteria to address an important public health issue. Supported by NIH/NIDCR Grant UO1 DE018902, and U01 DE018886.