Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis (NCT04731233) | Clinical Trial Compass
TerminatedPhase 4
Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis
Stopped: Could not recruit participants due to their refusal to be randomized in the study.
United States5 participantsStarted 2021-03-30
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating
Timeframe: Three Months
2
Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating