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$ 8 Million NIH Grant Supports Collaborative Study on Outcomes from High Dose Radiation Therapy

December 11, 2012

The NYU College of Dentistry’s Bluestone Center for Clinical Research is one of five institutions sharing an $8.15 million grant to examine treatment outcomes in head and neck cancer patients receiving high-dose radiation therapy.

As a site investigator, Bluestone Director Dr. Brian L. Schmidt, DDS, MD, PhD, will manage the enrollment of patients for the study entitled "Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients". Michael Brennan, DDS, MHS, Associate Chairman of the Department of Oral Medicine at Carolinas HealthCare System (CHS), and Rajesh V. Lalla, DDS, PhD, tenured Associate Professor of Oral Medicine at the University of Connecticut School of Dental Medicine, are Co-Principal Investigators for the project funded by the National Institute of Dental and Craniofacial Research (NIDCR).

The majority of patients with head and neck cancer receive high-dose radiation therapy which can irreversibly damage the oral and maxillofacial tissues. Damage to the salivary glands in particular can lead to a decreased flow of saliva and dry mouth, significantly increasing the risk of dental caries and tooth loss. Radiation also impedes bone healing, putting the patient at risk for osteoradionecrosis (ORN), a condition in which normal cells and blood vessels, in addition to the cancer cells, are destroyed by the radiation therapy. ORN is often induced by dental extraction, placing the at-risk patients in a vicious cycle, as they are more likely to need dental extraction following radiation. While there is some evidence to suggest patients experience significant dental morbidity following radiation therapy, there is no definitive data documenting the extent and severity. Without evidence-based guidelines, current care of these patients is based on individual and expert opinion. Patients enrolled this multi-center longitudinal cohort study will receive a standard dental examination to document any dental or oral conditions prior to starting their radiation therapy. Patients will be recalled every 6 months for up to two years to measure tooth loss and examine the failure rate of commonly used dental restorative materials. Researchers will use this data to identify risk factors for tooth loss and restoration failure and compare the effectiveness of different restoration materials.

“This will be a landmark clinical study as it will be the first study to systematically examine dental outcomes in a large population of over 750 patients receiving head and neck radiation therapy,” said Dr. Lalla. “We expect to not only document the substantial dental morbidity in this population but also identify risk factors for adverse outcomes. This valuable information will have a direct impact on the clinical care of thesepatients.”

The grant will be administered by Carolinas HealthCare System and patients will be enrolled at five satellite sites, each with a leading investigator: New York University (Dr. Brian L. Schmidt), Carolinas Medical Center (Dr. Michael Brennan), University of Connecticut Health Center (Dr. Lalla), Harvard University/Dana Farber Cancer Center (Dr. Nathaniel Treister), and the University of Pennsylvania (Dr. Thomas Sollecito). Dr. James Hodges from the University of Minnesota will operate the Data Coordinating Center for the study.

Dr. Schmidt looks forward to starting the study and said, “although radiation therapy can improve survival for head and neck cancer patients the negative effects of radiation on the teeth and jaws is life-long and progressive. I have seen in my practice that complications, such as ORN, can have a measurable impact on patients’ quality of life. This multi-center study could change that. The results might tip the balance so that while radiation is being used to control the cancer we can see oral health problems early on and keep our patients out of trouble.”