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Biologic Augmentation of TMJ Arthroscopy Using BMAC

Biologic Augmentation of TMJ Arthroscopy Using BMAC

Recruiting
18-75 years
All
Phase 3

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Overview

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

Inclusion Criteria:

  1. Participant is at least 18 years of age and not older than 75 years of age
  2. Participant is willing and able to provide written informed consent to participant in this study
  3. 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.)
  4. Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS)

Exclusion Criteria:

  1. Participant has not competed at least 30 days of conservative therapy
  2. Participant was diagnosed with central or neuropathic pain disorder
  3. Participant has a primary diagnosis of myofascial pain
  4. Participant has fibromyalgia
  5. Participant is pregnant or breastfeeding
  6. Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening
  7. Participant who has the following contraindications to MRI:
    • Electrical implants such as cardiac pacemakers or perfusion pumps
    • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
    • History of seizures
    • Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
    • Allergy to contrast die

Study details
    TMJ - Oral &Maxillofacial Surgery
    Oral and Maxillofacial Conditions
    TMJ Pain
    TMJ Arthralgia

NCT07536399

Weill Medical College of Cornell University

1 August 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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