The purpose of this project is to determine if Crescent Innovations polymer gels have application in treating TMJ pain, 7 million Americans suffer pain in the temporomandibular joint (i.e., the jaw joint) each year. The only long term non-invasive therapy for TMJ pain is non-steroidal anti-inflammatories, and they are less than 50% effective. The overall objective of this program is to develop a biologically absorbable polymer gel that may serve as a long-term minimally invasive therapy for treating pain in the temporomandibular joint associated with internal derangement and/or osteoarthritis (ID/OA). Currently the NIH recommends that minimally invasive procedures be used to treat TMJ disorders (TMD). Despite this, there are few minimally invasive therapies available to TMD patients or the doctors who treat them. Biologically absorbable polymer gels are currently used to treat osteoarthritis of the knee. There has been some work performed that suggests these gels would provide a benefit to TMD patients, but the work is limited. If a product of this type were available, it would be one of the only long-term minimally invasive therapies available to TMD sufferers. The primary objective of this Phase I SBIR application is to determine the feasibility of using proprietary Crescent Innovations polymer gels to treat ID/OA TMD. This will lead to a Phase II study, which will determine the long-term efficacy and safety impact of the polymer gel treatment. Therefore, the Specific Aim of this Application is to: Determine if Crescent Innovations enhanced formulations, specifically catering to the unique characteristics of the TM joint, provide superior clinical benefits in an animal model compared to a product used to treat OA of the knee.
