Overview

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