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NCT Number: NCT07536399

Biologic Augmentation of TMJ Arthroscopy Using BMAC

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, 10024, United States

Location contact

Jordan Augsburger

CONTACT

[email protected]

212.746.5175

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Participant is pregnant or breastfeeding
  • Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Kellenberger score at 6 Months.

    Time frame: Baseline; 6 months

    Participant MRIs will be given a Kellenberger score of 0-13. A higher Kellenberger scores indicate a higher degree of inflammation and damage.

Secondary outcomes

  1. Change in Maximum interincisal opening (MIO)

    Time frame: Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

    Distance measured on a ruler between the incisal edges in millimeters

  2. Change in Pain Scores

    Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

    Pain on Visual analogue score. Zero is equivalent to no pain and 10 indicates the worst possible pain.

  3. Change in Jaw Functional Limitation Scale (JFLS) Score

    Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

    JFLS is an 8 question survey on jaw functionality scored from 0 (no limitation) to 10 (severe limitation).

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Augsburger

CONTACT

[email protected]

212.746.5175

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois

Registry information

Official study title

Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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