NIH-Sponsored Trial Involves Treating Periodontitis in Hundreds of Type 2 Diabetics
STONY BROOK, N.Y., March 14, 2011 – The Stony Brook University School of Dental Medicine is leading a multicenter national clinical trial to evaluate whether treatment of chronic periodontitis will help improve diabetes control. Sponsored by the National Institutes of Health (NIH), the Diabetes and Periodontal Therapy Trial (DPTT) monitors blood sugar levels of those with Type 2 diabetes after periodontal therapy. The trial is the first of its kind in the United States.
The American Diabetes Association reports that Type 2 diabetes is the fifth leading cause of death in the U.S., affecting nearly 24 million Americans. Chronic Periodontitis affects roughly half of all Americans over the age of 55, but it is 2-to-4 times more likely to occur among people with diabetes, according to the American Academy of Periodontology.
“We hope the results of this clinical trial will support the research that clearly shows an association between chronic periodontitis and Type 2 diabetes and 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 trial and Assistant Professor of Periodontics and Implantology at the SBU School of Dental Medicine.
In 2008, Dr. Engebretson and colleagues within the School of Dental Medicine and School of Medicine received a $12.5 million five-year grant from the NIH to develop the format and research plan for a multicenter trial investigating the effectiveness of periodontal therapy in improving blood sugar levels in Type 2 diabetes – now named the DPTT.
In 2011, a supplemental NIH grant for the DPTT to Stony Brook will provide an additional $1.4 million for the trial, bringing the total award to $13.9 million. This two-year grant supplement will be used to further develop a clinical site for ongoing recruitment of study participants through May 2012.
Participants for the trial must be 35 years or older and have Type 2 Diabetes and gum disease. Those who are eligible will receive at no cost: a dental cleaning by a hygienist and a professional evaluation by a dentist; 6-8 office visits, which include periodontal treatment for 6 months; oral hygiene products and diabetic counseling, as well as compensation for time and travel.
The periodontal treatment involves an in-depth cleaning called scaling and root planing (SRP). SRP is a careful cleaning of the tooth root surfaces to remove plaque from pockets and remove bacteria and toxins from tooth root. Dr. Engebretson points out that research has consistently shown that SRP reduces the amount of bacteria associated with periodontal disease. Due to this finding, SRP is usually the first mode of treatment recommended for most patients. Some people do not require any further active treatment after SRP.
The entire trial will span 30 months and include four clinical sites. Stony Brook is the coordinating clinical center, and the other clinical sites are the University of Alabama in Birmingham, the University of Minnesota in Minneapolis, and the University of Texas Health Science Center in San Antonio. The NIH’s National Institute of Dental and Craniofacial Research sponsors the trial.
The shared goal of the four clinical centers is to recruit a total of 600 adults who also have untreated moderate to severe chronic periodontitis. Subjects will be recruited from the diabetes clinics, dental clinics and communities near each center.
Dr. Engebretson believes that in the long-run the study results have 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. The trial is also carrying out a mandate from the 2000 Surgeon General’s Report on Oral Health, which identified the relationship between improvement in periodontal health and glycemic control as an area in need of further investigation.
To participate in the clinical trial or to ask questions, please call Ruth J. Tenzler, RN, Study Coordinator at (631) 632-3964.