TMJ - Oral &Maxillofacial SurgeryPhase 3NCT07536399
Biologic Augmentation of TMJ Arthroscopy Using BMAC
A Phase 3 study testing Bone Marrow Aspirate Concentrate and Corticosteroid (CS) in people with TMJ - Oral &Maxillofacial Surgery and Oral and Maxillofacial Conditions, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TMJ - Oral &Maxillofacial Surgery, Oral and Maxillofacial Conditions, TMJ Pain
- What is being tested?
- Bone Marrow Aspirate Concentrate and Corticosteroid (CS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10024
Jordan Augsburger, 212.746.5175, joa7035@med.cornell.edu
About this study
Official title: Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial
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 .
Read more
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
- Being tested
- Bone Marrow Aspirate Concentrate, Corticosteroid (CS)
- Keywords
- TMJ pain, Oral and maxillofacial conditions, TMJ arthroscopy, bone marrow aspirate concentrate, BMAC, steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate ConcentrateBiological
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 group | Role | What they receive |
|---|---|---|
| BMAC Arm | Experimental | Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure Receives: Biological: Bone Marrow Aspirate Concentrate |
| Corticosteroid Arm | Active comparator | Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure Receives: Drug: Corticosteroid (CS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Kellenberger score at 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.
Measured: Baseline; 6 months
Secondary outcomes (3)
Change in Maximum interincisal opening (MIO)
Distance measured on a ruler between the incisal edges in millimeters
Measured: Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Pain Scores
Pain on Visual analogue score. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Jaw Functional Limitation Scale (JFLS) Score
JFLS is an 8 question survey on jaw functionality scored from 0 (no limitation) to 10 (severe limitation).
Measured: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ - Oral &Maxillofacial SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Reeve, DMD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536399
- Sponsor's protocol ID
- 25-08029208
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial
- ClinicalTrials.gov ID
- NCT07536399
- Acronym / sponsor ID
- 25-08029208
- Conditions
- TMJ - Oral &Maxillofacial Surgery, Oral and Maxillofacial Conditions, TMJ Pain, TMJ Arthralgia
- Keywords
- TMJ pain, Oral and maxillofacial conditions, TMJ arthroscopy, bone marrow aspirate concentrate, BMAC, steroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC Arm | Experimental | Biological: Bone Marrow Aspirate ConcentrateParticipants in this arm will receive BMAC injection during their TMJ arthroscopy procedure |
| Corticosteroid Arm | Active comparator | Drug: Corticosteroid (CS)Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate ConcentrateSingle dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy. | Biological | BMAC Arm |
| Corticosteroid (CS)Single dose injection of cortiosteroid into the TMJ area during arthroscopy. | Drug | Corticosteroid Arm |
Primary outcome
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.
3 secondary outcomes
Change in Maximum interincisal opening (MIO)
Time frame: Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Pain Scores
Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Jaw Functional Limitation Scale (JFLS) Score
Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwendolyn Reeve, DMD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone Marrow Aspirate Concentrate and Corticosteroid (CS) in people with TMJ - Oral &Maxillofacial Surgery and Oral and Maxillofacial Conditions, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Augsburger (212.746.5175, JOA7035@MED.CORNELL.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Kellenberger score at 6 Months. (time frame: Baseline; 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.