TMJ - Oral &Maxillofacial Surgery, Oral and Maxillofacial Conditions, TMJ Pain, TMJ Arthralgia
Conditions
Keywords
TMJ pain, Oral and maxillofacial conditions, TMJ arthroscopy, bone marrow aspirate concentrate, BMAC, steroid
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
Interventions
BIOLOGICALBone Marrow Aspirate Concentrate
Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
Single dose injection of cortiosteroid into the TMJ area during arthroscopy.
Sponsors
Weill Medical College of Cornell University
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Kellenberger score at 6 Months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum interincisal opening (MIO) | 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 |
| Change in Pain Scores | 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. |
| Change in Jaw Functional Limitation Scale (JFLS) Score | 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). |
Countries
United States
Contacts
CONTACTJordan Augsburger
PRINCIPAL_INVESTIGATORGwendolyn Reeve, DMD
Weill Medical College of Cornell University
Outcome results
None listed