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Corticosteroid

PRGF Supplementation for Temporomandibular Joint Disorder

Phase 4
Waitlist Available
Led By Charles G. Widmer, DDS
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral or bilateral TMJ arthralgia
Female
Must not have
Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
Current active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights

Summary

This trial will compare the effectiveness of two treatments for temporomandibular joint osteoarthritis, one with a steroid and one with platelet-rich growth factor supplementation.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of PRGF may include discomfort at injection site or infection. Triamcinolone could cause increased appetite, mood changes, trouble sleeping; long-term use might lead to bone thinning or weight gain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have pain in one or both of my jaw joints.
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I am female.
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I am between 40 and 80 years old.
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I have been diagnosed with osteoarthritis in my jaw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition like rheumatoid arthritis affecting my jaw joint.
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I have an active infection.
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I have been diagnosed with fibromyalgia.
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I have had a TMJ surgery or procedure before.
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I have received a steroid injection in my jaw joint.
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I have had TMJ pain for more than five years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Scale Measurement (VAS) of Intracapsular Pain Intensity

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PRGF ArmExperimental Treatment1 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 ArmActive Control1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteoarthritis (OA) that focus on promoting tissue healing and reducing inflammation include platelet-rich plasma (PRP), bone morphogenetic proteins (BMPs), and fibroblast growth factors (FGFs). PRP contains growth factors that stimulate tissue repair and modulate inflammation, potentially improving joint function and reducing pain. BMPs, such as BMP-7, contribute to tissue repair by suppressing catabolic activities of cytokines and promoting anabolic processes. FGFs, particularly FGF-18, have anabolic effects on cartilage, stimulating matrix formation and proteoglycan synthesis. These treatments are significant for OA patients as they target the underlying mechanisms of tissue degradation and inflammation, offering potential improvements in joint health and symptom relief.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,354 Previous Clinical Trials
713,341 Total Patients Enrolled
15 Trials studying Osteoarthritis
11,160 Patients Enrolled for Osteoarthritis
Charles G. Widmer, DDSPrincipal InvestigatorUniversity of Florida

Media Library

Triamcinolone Acetonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04731233 — Phase 4
Osteoarthritis Research Study Groups: PRGF Arm, Steroid Arm
Osteoarthritis Clinical Trial 2023: Triamcinolone Acetonide Highlights & Side Effects. Trial Name: NCT04731233 — Phase 4
Triamcinolone Acetonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731233 — Phase 4
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04731233 — Phase 4
~1 spots leftby Mar 2025