Gary Bouloux to lead multi-center study of metal hypersensitivity following TMJR

February 2021

Gary F. Bouloux, DDS, MD, MDSc, professor of surgery and interim chief of the Emory Division of Oral and Maxillofacial Surgery, has been awarded an Oral and Maxillofacial Surgery Foundation Research Support Grant to study the development of metal hypersensitivity following temporomandibular total joint replacement (TMJR). The grant received the Stephen B. Milam Award for earning the highest score from the OMS Foundation Committee.

Dr. Bouloux is Principal Investigator for the multicenter prospective study, and will collaborate with co-PIs Sarah Chisolm, MD, of the Emory Department of Dermatology, and oral and maxillofacial surgeons Gary Warburton, DDS, MD, at the University of Maryland, and Daniel Perez, DDS, at the University of Texas Health Science Center.

This will be the first study in the fields of both oral and maxillofacial surgery and orthopedics to measure metal hypersensitivity before and after TMJR. The aim of the study is to determine if metal hypersensitivity develops following TMJR, and if this condition correlates with patient reported outcome measures (PROMs).

After patients requiring TMJR have been screened and enrolled, they will complete several questionnaires including the Basic Symptom Inventory (BSI-18), the Jaw Function Limitation Scale (JFLS-8), and the Oral Health Impact Profile (OHIP-TMD). They will also receive a complete physical examination preoperatively (T0), and at six weeks (T1), 12 weeks (T2), and 12 months (T3).

Pressure Pain Threshold (PPT) testing will be performed preoperatively to classify patients into one of three clusters during data analysis: adaptive (lower pain sensitivity and lower psychological distress), pain sensitive (higher pain sensitivity but lower psychological distress), or global symptoms (higher in both pain sensitivity and psychological distress). It is hypothesized that patients' psychosocial factors and clustering are more likely to correlate with PROMS than the development of metal hypersensitivity.

Metal serum ion levels and the Leukocyte Transformation Test (LTT) will also be measured preoperatively and again at 12 months to determine if metal hypersensitivity has developed.

"We anticipate that this project will provide strong data regarding outcomes following TMJR for all patient types, and assist in identifying comorbid conditions that may predict poor outcomes following the procedure and potentially other pain driven TMJ surgeries," says Dr. Bouloux.