BMAC for Temporomandibular Joint Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment using Bone Marrow Aspirate Concentrate (BMAC) for individuals with temporomandibular joint disorder (TMJ pain) that hasn't improved with other treatments. Researchers aim to determine if BMAC injections during TMJ surgery can reduce inflammation and damage compared to the usual corticosteroid (CS) injections. Participants will be randomly assigned to receive either BMAC or steroids during their procedure. Suitable candidates for this trial should have ongoing TMJ pain and dysfunction despite trying treatments like pain relievers or physical therapy for at least 30 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves comparing BMAC to corticosteroid injections, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Bone Marrow Aspirate Concentrate (BMAC) is usually well-tolerated for joint issues. One study found that BMAC injections improved symptoms of temporomandibular joint (TMJ) disorders without causing major side effects. Another study demonstrated that a single BMAC injection was safe and improved knee osteoarthritis, suggesting it might also be safe for other joints like the TMJ. BMAC aims to ease symptoms and help repair joint tissues. While these results are encouraging, they rely on previous studies. Participants should consider this information when deciding whether to join the trial.12345
Why do researchers think this study treatment might be promising for TMJ?
Researchers are excited about the use of Bone Marrow Aspirate Concentrate (BMAC) for treating Temporomandibular Joint (TMJ) Disorder because it introduces a regenerative approach to healing. Unlike standard treatments like corticosteroid injections that focus mainly on reducing inflammation and pain, BMAC is derived from the patient's own bone marrow and contains cells that have the potential to repair and regenerate joint tissues. This could mean longer-lasting relief and improved joint function compared to current options. By harnessing the body's natural healing processes, BMAC offers a promising alternative for patients suffering from TMJ disorders.
What evidence suggests that this trial's treatments could be effective for TMJ disorder?
Research suggests that Bone Marrow Aspirate Concentrate (BMAC) may help treat jaw joint disorders. In this trial, participants in the BMAC arm will receive BMAC injections during their TMJ arthroscopy procedure. Studies have shown that BMAC can repair damage from jaw joint arthritis, leading to improved jaw movement and reduced pain. In one study, patients who received BMAC injections reported greater improvement in jaw function and pain relief than those who did not. Another study found that individuals with jaw joint disorders experienced better outcomes after receiving BMAC injections. While these findings are encouraging, further research is needed to confirm its effectiveness in larger groups.23567
Who Is on the Research Team?
Gwendolyn Reeve, DMD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults aged 18–75 with ongoing jaw joint pain (TMJ disorder) that hasn't improved after at least a month of standard treatments like medications, splints, or physical therapy. Participants must be able to give consent and have moderate or worse pain.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either BMAC or CS injection during TMJ arthroscopy
Follow-up
Participants visit the clinic for follow-up assessments and MRIs
What Are the Treatments Tested in This Trial?
Interventions
- Bone Marrow Aspirate Concentrate (BMAC)
- Corticosteroid (CS)
Trial Overview
The study compares two treatments during TMJ arthroscopy: one group gets an injection of Bone Marrow Aspirate Concentrate (BMAC), while the other receives a corticosteroid injection. Patients are randomly assigned to each group and followed for six months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure
Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
Collaborator
Citations
Bone marrow aspirate concentrate – A novel approach to ...
Bone marrow aspirate concentrate (BMAC) is able to reverse the degenerative effects of TMJ OA. However, further studies are mandatory with larger population and ...
Arthrocentesis for temporomandibular joint disorders - PMC
Clinical studies have demonstrated the effectiveness of arthrocentesis in managing temporomandibular joint disorders (TMDs). However, there is a lack of ...
Bone marrow aspirate concentrate - A novel approach to ...
Conclusion: Bone marrow aspirate concentrate (BMAC) is able to reverse the degenerative effects of TMJ OA however,further studies are mandatory ...
Bone Marrow Aspirate Concentrate – A Novel approach to ...
Similarly, Fayed et al. found that, after 1 week and 1 month, the test group showed significantly greater improvements in mandibular function and reduced ...
BMAC for Temporomandibular Joint Disorder
The goal of this clinical trial is to learn about the efficacy of using Bone Marrow Aspirate Concentrate (BMAC) during temporomandibular joint ( ...
Clinical Outcomes of Autologous Bone Marrow Aspirate ...
The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including ...
1-year results of a randomized clinical trial
Intra-articular TMJ BMNc injection improved clinical outcomes in TMD treatment. The Results of this first human-model study are promising.
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