Biologic Augmentation of TMJ Arthroscopy Using BMAC

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07536399
Phase
PHASE3
Status
Recruiting
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Conditions

  • Oral and Maxillofacial Conditions
  • TMJ - Oral &Maxillofacial Surgery
  • TMJ Arthralgia
  • TMJ Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspirate Concentrate — BIOLOGICAL
    Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
  • Corticosteroid (CS) — DRUG
    Single dose injection of cortiosteroid into the TMJ area during arthroscopy.

Study Details

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

Key Dates

First listed
Apr 17, 2026
Start date
May 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BMAC Arm
    Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure
  • Active Comparator: Corticosteroid Arm
    Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure

Primary Outcome Measure

Change from Baseline in Kellenberger score at 6 Months. [ Time Frame: Baseline; 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical College - NewYork-Presbyterian HospitalNew YorkNew York10024
Jordan Augsburger
[email protected]
212.746.5175

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By research site
Weill Cornell Medical College - NewYork-Presbyterian Hospital· New York, NY

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