Biologic Augmentation of TMJ Arthroscopy Using BMAC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWeill Medical College of Cornell University
About this trial
The goal of this clinical trial is to learn about the efficacy of using Bone Marrow Aspirate Concentrate (BMAC) during temporomandibular joint (TMJ) arthroscopy compared to standard arthroscopic procedures with corticosteroid (CS) injections in patients with pain (arthralgia) of the temporomandibular joint (TMJ) that has failed to respond to conservative treatment. The main question it aims to answer:
Does BMAC injection reduce the amount of inflammation and structural damage in the TMJ? Researchers will compare BMAC injection to corticosteroid injections see if BMAC injection helps .
Participants will :
* Be randomized to receive either BMAC or CS injection during TMJ arthroscopy * Visit the clinic for 3 follow up visits over 6 months and answer questionnaires * have 2 MRIs of their jaw
Eligibility criteria
Qualifiers
Participant is at least 18 years of age and not older than 75 years of age
Participant is willing and able to provide written informed consent to participant in this study
Participant has symptoms of TMJ arthralgia (pain) with significant temporomandibular joint pain and dysfunction despite at least 30 days of conservative therapy (NSAIDS, muscle relaxants, bite splints, PT, warm compresses, soft diet, etc.)
Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS)
Disqualifiers
Participant has not competed at least 30 days of conservative therapy
Participant was diagnosed with central or neuropathic pain disorder
Participant has a primary diagnosis of myofascial pain
Participant has fibromyalgia
Trial design
Treatments tested in this trial
- Bone Marrow Aspirate Concentrate
- Corticosteroid (CS)
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
Collaborator
Source ClinicalTrials.gov