568 The Diabetes and Periodontal Therapy Trial (DPTT)

Thursday, March 22, 2012: 3:30 p.m. - 4:45 p.m.
Presentation Type: Poster Session
S. ENGEBRETSON1, B. MICHALOWICZ2, E.R. SEAQUIST3, M. REDDY4, C.E. LEWIS5, T. OATES6, D. TRIPATHY7, J. KATANCIK8, P.R. ORLANDER9, D. PAQUETTE10, M.C. GELATO11, N. HANSON12, M.Y. TSAI13, M.J. FAZZARI14, E. SCHOENFELD15, and L. HYMAN14, 1Periodontology and Implant Dentistry, New York University, New York, NY, 2Dept. of Preventive Sciences, University of Minnesota -, Minneapolis, MN, 3Medicine/DEM, University of Minnesota, Minneapolis, MN, 4Dept. of Periodontology, University of Alabama at Birmingham, Birmingham, AL, 5Preventive Medicine, University of Alabama, Birmingham, AL, 6School of Dentistry, University of Texas at San Antonio, San Antonio, TX, 7Medicine, University of Texas - San Antonio / Health Science Ctr, San Antonio, TX, 8Dept. of Periodontics, University of Texas at Houston, Houston, TX, 9Intern Medicine, Endocrinology, University of Texas - Houston/Health Science Center, Houston, TX, 10Dental Medicine, State University of New York - Stony Brook, Stony Brook, NY, 11State University of New York - Stony Brook, Stony Brook, NY, 12Lab Medicine/Pathology, University of Minnesota, Minneapolis, MN, 13Lab Medicine and Pathology, University of Minnesota, Minneapolis, MN, 14Preventive Medicine, State University of New York - Stony Brook, Stony Brook, NY, 15Preventive Medicine, State University of New York - Stony Brook, Stony Brook
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.
This abstract is based on research that was funded entirely or partially by an outside source: NIH/NIDCR Grant UO1 DE018902, and U01 DE018886

Keywords: Clinical trials, Diabetes, Periodontal disease and Therapeutics
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