Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will evaluate the relative efficacy of TMJ arthrocentesis with a supplementation of platelet-rich growth factors (PRGF) compared to TMJ arthrocentesis with a steroid supplementation (a known effective therapy) for patients with TMJ OA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Mitogens; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Female

• 40 - 80 years of age

• Unilateral or bilateral TMJ arthralgia

• Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

• TMJ sounds (crepitus or click or both)

• Mild-moderate masticatory muscle myalgia

• History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain

Exclusion Criteria:

• Contraindication to sedation including pregnancy or medical history

• Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)

• History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy

• History of steroid injection in TMJ

• TMJ pain greater than five years

• History of narcotic drug use on a scheduled basis

• Current active infection

• Fibromyalgia