Researchers at Stony Brook University’s (SBU) School of Dental Medicine and School of Medicine received a $12.5 million five-year grant from the National Institute of Dental and Craniofacial Research (NIDCR), an arm of the National Institutes of Health, to conduct a multi-center clinical trial to evaluate whether treatment of chronic periodontitis may help to improve diabetes control. The study will be the largest clinical trial of diabetes and periodontitis to date and may lead to potential improvements in diabetes patient care. This collaborative effort, led by the SBU team, includes researchers from the University of Alabama, University of Minnesota, and the University of Texas.
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 further investigation. Thus, SBU researchers were prompted to design a large scale clinical trial to meet this research need and to address the important public health goal of improving the standard of care for patients with diabetes. They will test whether non-surgical periodontal therapy helps to improve glycemic control in patients with Type 2 diabetes.
According to the American Diabetes Association, Type 2 diabetes is the fifth leading cause of death in the U.S. and affects an estimated 23.6 million Americans (7.8% of the population). The American Academy of Periodontology estimates that chronic periodontitis affects about half of Americans over the age of 55 but is 2 to 4 times more likely to occur among people with diabetes.
“Research clearly shows an association between chronic periodontitis and Type 2 diabetes, and there is early evidence that treating periodontal infection and inflammation can improve glycemic control,” says Steven Engebretson, D.M.D., M.S., M.S., Principal Investigator for the study and Assistant Professor of Peridontics and Implantology at the Stony Brook University School of Dental Medicine. “Previous studies in this area have been encouraging but are too small to be conclusive. This will be the first large multi-center study to determine whether periodontal treatment can improve glycemic control.”
Dr. Engebretson says that scientifically the exact connection between periodontitis and diabetes or blood sugar control has not been fully defined. He adds that researchers suspect the association is related to inflammatory molecules caused by the periodontal infection that reach the circulation and disrupt the insulin pathway.
“Inflammation anywhere in the body can lead to glucose management problems, and keeping glucose levels as close to normal as possible is the key to managing diabetes,” says Dr. Ralph DeFronzo, Deputy Director of the Texas Diabetes Institute and Co-Investigator of the study. “If treating chronic periodontitis can help reduce blood glucose, the implications could be very significant to patient care.”
“Our study will address limitations of prior studies and will follow the highest standards for clinical trial design and conduct,” says Leslie Hyman, Ph.D., Director of the Coordinating Center for the study, and Professor, SBU Department of Preventive Medicine. “The multi-disciplinary study team includes leading researchers from the fields of periodontics, diabetology, clinical trials, and biostatistics who will provide their different expertise to ensure that the study can provide a clear answer to this important question.”
Drs. Engebretson and Hyman’s colleagues from SBU include Elinor Schoenfeld, Ph.D., and Li Ming Dong, Ph.D. The Clinical Centers are led by Dr. Michael Reddy and Dr. Beth Lewis of the University of Alabama, Dr. Bryan Michalowicz, Dr. Michael Tsai, and Dr. Betsy Seaquist of the University of Minnesota, and Dr. Thomas Oates and Dr. Ralph DeFronzo of the University of Texas. Dr. Mohammed Saad and Dr. Kevin A. Peterson are consultants for the study.
Participant enrollment in the trial is slated to begin during spring/summer 2009.