What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include analgesics like acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen and ibuprofen, and intraarticular glucocorticoid injections. Side effects of these treatments can include gastrointestinal issues, cardiovascular risks, and potential joint damage with long-term use of glucocorticoids. Regenerative therapies like Platelet-Rich Plasma (PRP) and PRGF, which are being studied for their tissue healing and anti-inflammatory properties, generally have minor and transient side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site. However, there is a general risk of local infection associated with intraarticular injections.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. Commonly approved treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections. While platelet-rich plasma (PRP) and other regenerative therapies like PRGF are being studied for their potential to promote tissue healing and reduce inflammation, they are not yet widely approved by the FDA for osteoarthritis treatment. Current research is ongoing to evaluate their efficacy and safety in clinical settings.

What other types of research exist?

Promising alternatives to TMJ Arthrocentesis with PRGF for osteoarthritis patients include: 1) Intra-articular injection of hyaluronic acid (HA), which can provide lubrication and reduce pain. 2) Intra-articular injection of insulin-like growth factor-1 (IGF-1) suspended in hyaluronan, which has shown potential in improving cartilage and subchondral bone repair. 3) Platelet-rich plasma (PRP) injections, which have regenerative properties and can promote tissue healing and reduce inflammation.

← Back to Search

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

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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.

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.

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.

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

Select...

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

Select...

I am female.

Select...

I am between 40 and 80 years old.

Select...

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:

Select...

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

Select...

I have an active infection.

Select...

I have been diagnosed with fibromyalgia.

Select...

I have had a TMJ surgery or procedure before.

Select...

I have received a steroid injection in my jaw joint.

Select...

I have had TMJ pain for more than five years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analog Scale Measurement (VAS) of Intracapsular Pain Intensity

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

0 / 10Eligibility criteria met

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.