Two professors at the UF College of Dentistry are working together to create a five-year clinical trial to determine if laser light treatments are effective at reducing pain in patients who suffer with temporomandibular disorders, or TMD. TMDs are the most-common cause of chronic pain in the orofacial region and are caused by complex musculoskeletal disorders that create pain and limit jaw function.
The National Institutes of Health National Institute of Dental and Craniofacial Research, or NIDCR, has awarded $559,388 to fund the development of, “Understanding Laser Light Treatment Applications for TMD, or ULLTRA-TMD.” ULLTRA-TMD will be a clinical study aimed at determining whether laser and LED light therapies, also known as photobiomodulation, or PBM, are effective treatments for pain triggered by temporomandibular disorders.
“Standard treatments for TMD, including intraoral appliances and analgesic medications, aren’t effective in resolving pain in a large proportion of TMD patients and we need to identify new treatments to reduce the pain and suffering for patients, and laser light treatments are one of the avenues being investigated,” said Margarete Ribeiro-Dasilva, D.D.S., M.S., Ph.D., a prosthodontist in the Department of Restorative Dental Sciences, and the lead investigator on the project.
Roger Fillingim, Ph.D., is the co-PI for ULLTRA-TMD, and he served as Ribeiro-Dasilva’s mentor during her postdoctoral research at UF. Fillingim, a distinguished professor in the Department of Community Dentistry & Behavioral Science, is the director of the UF Pain Research & Intervention Center of Excellence and a well-known expert in the study of pain. He investigates biological and psychosocial contributions to individual differences in pain, and has a substantial track record of research related to TMDs.
An increasing body of evidence suggests that Photobiomodulation, or PBM, before known as Low Laser Therapy, may be effective in treating different types of musculoskeletal pain, including TMDs. However, previous studies have had significant methodological limitations so it is still unknown if PBM is truly effective for TMD pain.
“Our study methodology is constructed to remove limitations of some previous studies. A new PBM device makes it possible to create a true double-blind study. Neither the patient nor the study team members will know whether the treatment delivered is actually PBM or a placebo,” Fillingim said.
In addition, the ULLTRA-TMD study will evaluate participants blood biomarkers to see if the way that PBM decreases pain is by decreasing inflammation, a biological process for pain reduction.
The recent NIDCR funding is for the planning phase of ULLTRA-TMD. Ribeiro-Dasilva and Fillingim will work with a team of faculty to finalize protocols and develop implementation plans. The team includes Cesar Migliorati, D.D.S., M.S., Ph.D., and Frank Gibson, Ph.D., both on faculty in dentistry; and Zhigang Li, M.S., Ph.D., from the UF Department of Biostatistics in the College of Public Health & Health Professions.
The ULLTRA-TMD Study
After the one-year planning phase, the research team will submit their final plans to the NIDCR to request funding for a five-year clinical trial. At this point, the team expects the study will enroll more than 100 people experiencing TMD pain, who will be randomly assigned to receive either actual or placebo PBM.
Each individual will attend eight treatment visits over several weeks; participants’ pain and other symptoms will be assessed before and up to six months after treatment. Participants’ blood biomarkers and pain thresholds will studied to determine whether PBM reduces TMD pain by decreasing pain sensitivity and inflammation. If ULLTRA-TMD shows that PBM is effective for TMD pain, this could be the first step in providing a new safe and effective treatment to improve quality of life in individual suffering from the painful, chronic condition.
UF Pain Research & Intervention Center of Excellence
UF PRICE is a multi-college Center of Excellence that serves as the professional home for UF scientists, clinicians, and trainees dedicated to improved understanding and treatment of pain. PRICE is affiliated with and supported by the UF Clinical and Translational Science Institute, or CTSI, and receives strong support from the UF Institute on Aging and the UF Health Cancer Center. PRICE provides member investigators with several resources and services in order to facilitate clinical and translational pain research at UF, including assistance with protocol development and assistance with recruitment of research participants. Also, PRICE offers facilities and services to assist investigators with collection of pain assessment data in their research protocols, via the Pain Clinical Research Unit (see below). Investigators can conduct their own studies in the PainCRU, or they can request that the PainCRU staff collect the data for their protocol.
In addition, PRICE endeavors to enhance the intellectual and professional work environment for the UF pain research community by coordinating training activities related to pain, including our T32 training grant in translational pain research, as well as journal clubs, seminar series, and a monthly Pain Interest Group.