Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois | UNKNOWN |
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMAC Arm | Experimental | Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure |
|
| Corticosteroid Arm | Active Comparator | Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximum interincisal opening (MIO) | Distance measured on a ruler between the incisal edges in millimeters | Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op |
| Change in Pain Scores |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Augsburger | Contact | 212.746.5175 | JOA7035@MED.CORNELL.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Gwendolyn Reeve, DMD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College - NewYork-Presbyterian Hospital | New York | New York | 10024 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Corticosteroid (CS) | Drug | Single dose injection of cortiosteroid into the TMJ area during arthroscopy. |
|
Pain on Visual analogue score. Zero is equivalent to no pain and 10 indicates the worst possible pain.
| 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). | Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op |