Biologic Augmentation of TMJ Arthroscopy Using BMAC
NCT07536399 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-07-29
Summary
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
Conditions
- TMJ - Oral &Maxillofacial Surgery
- Oral and Maxillofacial Conditions
- TMJ Pain
- TMJ Arthralgia
Interventions
- BIOLOGICAL
-
Bone Marrow Aspirate Concentrate
Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
- DRUG
-
Corticosteroid (CS)
Single dose injection of cortiosteroid into the TMJ area during arthroscopy.
Sponsors & Collaborators
-
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
collaborator UNKNOWN -
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Gwendolyn Reeve, DMD · Weill Medical College of Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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