PRGF Supplementation for Temporomandibular Joint Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for temporomandibular joint (TMJ) osteoarthritis, which causes pain and difficulty moving the jaw. Researchers aim to determine if platelet-rich growth factors (PRGF), a healing substance derived from blood, are more effective than the usual steroid treatment, triamcinolone acetonide, following arthrocentesis (a small needle procedure to wash out the joint). Women aged 40-80 with jaw joint pain, clicking sounds, and unsuccessful previous treatments may be suitable candidates. Participants will receive either PRGF or a steroid to compare outcomes. As a Phase 4 trial, this research involves FDA-approved treatments that have proven effective, aiming to understand their benefits for more patients.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have a history of non-surgical treatment, including NSAID therapy, for at least 6 weeks without resolving pain, which suggests you might continue some treatments.
What is the safety track record for these treatments?
Research has shown that platelet-rich growth factor (PRGF) treatments are generally safe for managing TMJ disorders. Studies have found that PRGF aids in healing and pain relief without major side effects. For instance, one study found it to be a safe and possibly effective treatment, though further research is needed for confirmation.
Triamcinolone acetonide, a type of steroid, also treats TMJ and is considered safe when injected directly into the joint. However, some studies suggest these injections might affect the jaw bone and joint disc over time.
Both treatments are usually well-tolerated, but considering their possible risks is important. Always consult a healthcare provider about any concerns before joining a clinical trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for Temporomandibular Joint Disorder (TMJ) because they explore different approaches to managing joint inflammation and pain. Unlike the standard steroid treatments, which typically involve corticosteroids like triamcinolone acetonide to reduce inflammation, the PRGF (Plasma Rich in Growth Factors) treatment is unique because it uses components from the patient's own blood to promote tissue healing and regeneration. This personalized approach could potentially improve joint health naturally and reduce the need for repeated steroid injections, offering a promising alternative for those seeking long-term relief.
What evidence suggests that this trial's treatments could be effective for TMJ osteoarthritis?
Research has shown that platelet-rich growth factors (PRGF), which participants in this trial may receive, can effectively reduce pain and improve joint function in people with temporomandibular joint (TMJ) osteoarthritis. PRGF, derived from a person's own blood, works by activating cells that may help repair joint tissue. Studies indicate that patients treated with PRGF experienced significant pain reduction and improved mouth movement over time.
Another group of participants in this trial will receive Triamcinolone acetonide, a type of steroid effective in treating TMJ disorders. It helps reduce pain and swelling in the joint. Research found that 90% of patients experienced more than a 50% improvement in chewing pain after receiving steroid injections. Both treatments offer promising options for people dealing with TMJ issues.36789Who Is on the Research Team?
Charles Widmer, D.D.S
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for women aged 40-80 with mild to moderate jaw muscle pain, TMJ joint pain, and osteoarthritis diagnosed by specific criteria. They must have tried non-surgical treatments like mouth appliances or NSAIDs without relief. Excluded are those with active infections, fibromyalgia, recent steroid injections in the TMJ, chronic narcotic use, rheumatologic disorders affecting the TMJ, contraindications to sedation (including pregnancy), long-term TMJ pain over five years or previous TMJ procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo TMJ arthrocentesis followed by either PRGF or steroid supplementation
Follow-up
Participants are monitored for pain and joint function at 1, 3, and 6 months post-treatment
Crossover Treatment (if needed)
Participants not experiencing improvement at 3 months may receive a second TMJ arthrocentesis with the alternative treatment
What Are the Treatments Tested in This Trial?
Interventions
- Plasma Rich in Growth Factor (PRGF) Supplementation
- Triamcinolone Acetonide
Triamcinolone Acetonide is already approved in United States, European Union, Canada, Japan for the following indications:
- Knee osteoarthritis
- Skin allergies
- Respiratory allergies
- Knee osteoarthritis
- Skin allergies
- Respiratory allergies
- Knee osteoarthritis
- Skin allergies
- Respiratory allergies
- Knee osteoarthritis
- Skin allergies
- Respiratory allergies
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor