The 2000 Surgeon General's Report on Oral Health identified the relationship between improvement in periodontal health and glycemic control as an area in need of intervention studies. To date there has been no adequately powered clinical trial to address this question. The proposed Diabetes and Periodontics Trial (DPT) is a multi-center, randomized, controlled single-masked Phase III clinical trial designed to test whether non-surgical periodontal therapy (scaling and root planing) is effective in reducing HbA1c of patients with type 2 diabetes and untreated chronic periodontitis compared to a control group who will receive no initial treatment. Delayed treatment will be offered to the control group after the 6-month visit. The secondary aims will evaluate whether improvement in clinical measures of chronic periodontitis are related to changes in systemic inflammatory markers, HbA1c, and measures of insulin resistance in these patients. Over a two and a half year period, four Clinical Centers from Schools of Medicine and Dentistry in Birmingham, AL, Philadelphia, PA, San Antonio, TX, and Minneapolis, MN will recruit a total of 600 adults (150/center) 35 years of age or older, with type 2 diabetes of at least 3 months duration, untreated moderate to severe chronic periodontitis, HbA1c between 7.5% and 9%, and who meet additional specific inclusion and exclusion criteria. Subjects will be recruited from the diabetes clinics, dental clinics and communities at each center. All eligible subjects will be examined at baseline, 3- months, and 6-months;at each visit a periodontal examination will be conducted and HbA1c values determined. Treatment will consist of scaling and root planing under local anesthetic. A standardized common protocol, and a detailed Manual of Procedures will be used at all centers. The primary study outcome will be change in HbA1c values at 6-months. Secondary outcomes are changes in periodontal clinical measures (gingival index, bleeding on probing, pocket depths, and clinical attachment levels), changes in inflammatory markers (serum C-reactive protein, plasma TNF, and serum IL-6) and changes in the Homeostasis Model Assessment (HOMA2). This study has the potential to provide a scientific basis for an improvement in the standard of care for patients with diabetes thus addressing one of the Public Health Service's Healthy People 2010 goals. This application seeks support for the Administrative Center/Study Chair. Separate applications have been submitted by the Coordinating Center, and four Clinical Centers. Project Narrative Having periodontal (gum) disease may make it more difficult to control blood sugar levels for people with type 2 diabetes. This study will test whether non-surgical periodontal disease treatment leads to improved blood sugar control. Improving the way people manage their blood sugar is key to preventing diabetes complications and reducing health care costs.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DE018902-04
Application #
8103001
Study Section
Special Emphasis Panel (ZDE1-YL (68))
Program Officer
Atkinson, Jane C
Project Start
2008-07-21
Project End
2013-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
4
Fiscal Year
2011
Total Cost
$2,842,256
Indirect Cost
Name
State University New York Stony Brook
Department
Dentistry
Type
Schools of Dentistry
DUNS #
804878247
City
Stony Brook
State
NY
Country
United States
Zip Code
11794
Geisinger, Maria L; Michalowicz, Bryan S; Hou, Wei et al. (2016) Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial. J Periodontol 87:900-13
Borgnakke, Wenche S; Chapple, Iain L C; Genco, Robert J et al. (2014) The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract 14:127-32
Schoenfeld, Elinor R; Hyman, Leslie; Simpson, Leslie Long et al. (2014) An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial. Clin Investig (Lond) 4:1065-1081
Michalowicz, Bryan S; Hyman, Leslie; Hou, Wei et al. (2014) Factors associated with the clinical response to nonsurgical periodontal therapy in people with type 2 diabetes mellitus. J Am Dent Assoc 145:1227-39
Engebretson, Steven P; Hyman, Leslie G; Michalowicz, Bryan S (2014) Hemoglobin A1c levels among patients with diabetes receiving nonsurgical periodontal treatment--reply. JAMA 311:1921-2
Engebretson, Steven; Kocher, Thomas (2013) Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Clin Periodontol 40 Suppl 14:S153-63
DPTT study group; Engebretson, S; Gelato, M et al. (2013) Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes an Contemp Clin Trials 36:515-26
Engebretson, Steven P; Hyman, Leslie G; Michalowicz, Bryan S et al. (2013) The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA 310:2523-32
Engebretson, Steven; Kocher, Thomas (2013) Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol 84:S153-69