PRGF Supplementation for Temporomandibular Joint Disorder

Overseen By Charles G. Widmer, DDS

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Florida

Must not be taking: Narcotics

Disqualifiers: Rheumatologic disorders, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment for jaw joint arthritis that uses a special substance from the patient's own blood to help repair damaged tissues. It aims to find out if this new method is better than the current standard treatment. The study focuses on patients with jaw joint arthritis who experience pain and tissue damage.

Research Team

Charles Widmer, D.D.S

Principal Investigator

University of Florida

Eligibility Criteria

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

I have pain in one or both of my jaw joints.

I am female.

I am between 40 and 80 years old.

Exclusion Criteria

History of narcotic drug use on a scheduled basis

I have a condition like rheumatoid arthritis affecting my jaw joint.

I have an active infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo TMJ arthrocentesis followed by either PRGF or steroid supplementation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and joint function at 1, 3, and 6 months post-treatment

6 months

3 visits (in-person)

Crossover Treatment (if needed)

Participants not experiencing improvement at 3 months may receive a second TMJ arthrocentesis with the alternative treatment

1 day

1 visit (in-person)

Treatment Details

Interventions

• Plasma Rich in Growth Factor (PRGF) Supplementation
• Triamcinolone Acetonide

Trial Overview The study tests if injecting growth factors (PRGF) into the jaw joint after a cleaning procedure (arthrocentesis) is better than using a steroid (Triamcinolone Acetonide). It's a head-to-head comparison in patients with jaw arthritis to see which treatment reduces inflammation and pain more effectively.

Participant Groups

Group I: PRGF Arm Experimental Treatment 1 Intervention

The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.

Group II: Steroid Arm Active Control 1 Intervention

Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.

Triamcinolone Acetonide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in European Union as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Canada as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Japan as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+