Status:
TERMINATED
Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis
Lead Sponsor:
University of Florida
Conditions:
TMJ
Osteoarthritis
Eligibility:
FEMALE
40-80 years
Phase:
PHASE4
Brief Summary
Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will ...
Detailed Description
Temporomandibular disorders (TMD) are musculoskeletal disorders that are commonly encountered, with pain in the temporomandibular joint (TMJ) and jaw closing muscles. Pain that involves the temporoman...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04731233
Start Date
March 30 2021
End Date
February 21 2024
Last Update
February 21 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610