The School of Dentistry is one of four sites recruiting patients for a clinical trial to test whether the treatment of chronic periodontitis, or gum disease, improves control of Type 2 diabetes. This study is the largest clinical trial of diabetes and periodontitis to date, and the hope is that its results will lead to improvements in diabetes patient care.
"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 Michael Reddy, D.M.D., co-principal investigator. "Previous studies in this area have been encouraging, but too small to be conclusive.
|(From left to right) Cora E. Lewis, Michael Reddy, Javetta Jackson and Janet Turman are enrolling, teaching and studying patients as part of a clinical trial to test whether the treatment of gum disease can help Type 2 diabetics control the disease.
"This is the first large, multi-center study to determine if periodontal treatment can improve glycemic control," Reddy said.
Reddy and co-principal investigator Cora E. Lewis, M.D., in Preventive Medicine, will test whether non-surgical periodontal therapy has a positive impact on glycemic control for Type 2 diabetics. Six hundred adults with Type 2 diabetes and chronic periodontitis are being randomized at four sites: UAB; the University of Minnesota, Minneapolis; the University of Texas Health Science Center, San Antonio; and Stony Brook University, Stony Brook, New York.
Researchers suspect the association between chronic periodontitis and diabetes is related to inflammatory molecules caused by periodontal infection that reach the circulation and disrupt the insulin pathway. Still, the exact connection between periodontitis and diabetes or blood-sugar control has not been defined.
"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," Reddy says. "In this study, we are working with patients to teach them how to clean their teeth and see if we can eliminate that inflammation. If treating chronic periodontitis can help reduce blood glucose, the implications could be very significant to patient care."
Study participants will be randomly assigned to receive either initial non-surgical periodontal therapy with chlorhexidine rinse (treatment subjects) or delayed non-surgical periodontal therapy (control subjects). Control subjects will be offered delayed periodontal therapy (scaling and root planing) following the six-month visit. Participants in both study arms will receive oral-hygiene instruction and lifestyle information at baseline and at the three- and six-month visits.
Recruiting for the five-year study began in November 2009 and will continue for the next 18 months. Those enrolled in the study will be monitored for six months.
Those eligible to participate in the study:
- Must be at least 35 years old
- Have had physician-diagnosed Type 2 diabetes for more than three months
- Be under the care of a physician for diabetes management
- Have moderate-to-severe chronic periodontitis
- Have had no definitive periodontal treatment during the six months prior to enrollment
- Have at least 16 natural teeth
Qualified participants will receive teeth cleaning, periodontal treatment and dental examinations at no cost. Compensation is available, and parking will be validated for clinic visits. For more information on enrolling in the trial, call 975-7117 or 934-1503. You can also e-mail Janet Turman, study recruitment coordinator, at firstname.lastname@example.org.