Forsyth Researchers Embark On Landmark Study of Gum Disease Treatment

Researchers at The Forsyth Institute have embarked on a landmark study to assess the relative effectiveness of surgical and non-surgical treatment for periodontitis?the advanced form of periodontal disease that affects nearly a third of U.S. adults over age 35.

The research--to take place in Cambridge, Somerville, Framingham, and on Cape Cod--will be conducted in collaboration with the Delta Dental Plan of Massachusetts and the Harvard School of Public Health. It is the first-ever community-based study to compare the benefits, risks, and limits of surgical and non-surgical methods used to treat gum disease in real-world, clinical practice.

Some 75 percent of U.S. adults over age 35 have a mild form of gum infection known as gingivitis, which causes inflamed or bleeding gums, according to Richard Niederman, DMD, Director of the Forsyth Center for Evidence-Based Dentistry and the principal investigator. However, in periodontitis, the bacteria have spread from the gums to the bones that support the teeth--a situation that can lead to bone and tooth loss if patients do not receive appropriate care. Equally important, periodontal disease has also been associated with increased risk of diabetes and heart disease.

For many years, surgery has been the most effective periodontitis treatment available and it is currently considered "the gold standard" of care, Niederman says. However, surgery may not eliminate the bacteria now known to cause the disease, and patients sometimes try to avoid surgery, which they may associate with discomfort and cost. New evidence suggests that non-surgical treatments using scaling, root planing, antibiotics, and mouthwashes may be helpful in many cases.

However, antibiotics do not eliminate the pockets where the bacteria live, and patients can have significant reactions if drugs are used. And because previous studies of non-surgical treatments have been conducted in controlled settings with particular sorts of patients, it can be difficult for general dentists to be sure which treatments will best serve the individuals they see in daily practice.

"We need to know how well non-surgical methods stack up against surgical treatment in the 'real' world, where patients may be of different ages and have a variety of health conditions," Niederman says. "We also need to know what risks patients and dentists run if they use these new treatments."

Hence, the study team will use a research model similar to those used in other medical specialties?such as that of the well-known (and much longer term) Framingham Heart Study?in which patients are followed over a period of time without intervention in their treatment or daily lives. Such models have rarely been used in the dental field.

In the 5-year study, some 400 subscribers to Delta Dental who are patients of participating dentists will undergo periodic, oral examinations conducted by an independent team of dentists and hygienists. The examinations will take place over a three-year period--before, during and after the patients are treated with antibiotics or with surgery, as prescribed by their own dentists or periodontists. Those conducting the examinations will not be aware of where or how the patients were treated.

Currently, many individuals with advanced periodontal disease apparently do not get the care they need. According to Robert Compton, DDS, director of disease management at Delta Dental, while 30 percent of adults have advanced periodontal disease, only 3 percent of care dollars are spent on periodontal surgery. This suggests that patients with periodontal disease are not being recognized, not being treated, or are avoiding care.

The study aims to gather hard data in order to give clinicians a clearer picture of which model keeps their patients healthier over the long run?which could, potentially, open up treatment options and encourage patients to partake of them.

Co-investigator Chester W. Douglass, DMD, MPH, PhD, points out that "if non-surgical treatments prove effective, they can be administered by general dentists, bringing periodontal therapy to more people. On the other hand, if the surgical model is more effective, patients who are hesitant about surgery may be encouraged to undergo it." Dr. Douglass is Professor of Epidemiology at the Harvard School of Public Health and Chair of the Department of Oral Health Policy and Epidemiology at the Harvard School of Dental Medicine.

Although beyond the scope of the current study, it is also possible that a combination of treatments could prove effective. According to Compton, "The more options patients have, the more likely they will be to access periodontal care before serious health problems occur."

The examinations will take place at neutral sites. A data safety monitoring board will review and oversee the study's progress, validity, clinical data and data analysis for accuracy and interpretation, patient safety and ethics, and will report findings. Board members include a clinical statistician, a medical ethicist, an attorney, a public health dentist, and a practicing periodontist.

The study is funded by a $2 million grant from the National Institute of Dental and Craniofacial Research, a Division of the National Institutes of Health. It is the first study to be conducted under the auspices of the Forsyth Center for Evidence-Based Dentistry. Dr. Niederman initiated his evidence-based dentistry work in 1997 while on the faculty of the Harvard School of Dental Medicine. He moved to Forsyth in 2001 to establish the Center for Evidence-Based Dentistry. Its goals are to improve the underlying evidence base for health care, to communicate this information to the profession and the public, and ultimately to improve health.

In addition to his Forsyth appointment, Dr. Niederman is Associate Professor of Health Policy and Health Services Research at the Boston University School of Dental Medicine.