Health TrialsbyHealthPanel

Biologic Augmentation of TMJ Arthroscopy Using BMAC

ConditionsTMJ - Oral &Maxillofacial SurgeryOral and Maxillofacial ConditionsTMJ PainTMJ Arthralgia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWeill Medical College of Cornell University

About this 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 .

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Aspirate Concentrate

    Biological/Vaccine

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: BMAC ArmExperimental treatment 1 intervention
Group B: Corticosteroid ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline; 6 months

Secondary outcomes

1

Change in Maximum interincisal opening (MIO)

Distance measured on a ruler between the incisal edges in millimeters

Time frame
Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
2

Change in Pain Scores

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

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

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois

Collaborator

Source ClinicalTrials.gov
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