Recruiting
Phase 3

BMAC vs. CS

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07536399

Conditions

TMJ - Oral &Maxillofacial Surgery

Oral and Maxillofacial Conditions

TMJ Pain

TMJ Arthralgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate Concentrate

Corticosteroid (CS)

Study Details

Brief 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

Study ID

NCT07536399

Start date

May 1, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Corticosteroid (CS)

Single dose injection of cortiosteroid into the TMJ area during arthroscopy.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College - NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10024

Contacts

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • TMJ pain
  • Oral and maxillofacial conditions
  • TMJ arthroscopy
  • bone marrow aspirate concentrate
  • BMAC
  • steroid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-07-29.