CompletedNot Applicable

Platelet-Rich Fibrin and Hyaluronic Acid vs. Hyaluronic Acid Injection for TMJ Internal Derangement

Egypt36 participantsStarted 2024-09-18

Plain-language summary

Injectable PRF technology, according to literature evidence, ensures the release of growth factors over time which play a major role in the release of regenerative factors for tissue repair after injection, while HA is an anti-inflammatory medication that can provide rapid relief from pain and inflammation in joints. It is a major natural component of synovial fluid that plays an important role in lubrication of synovial tissues However, its effect is typically temporary, and it doesn\'t promote tissue healing or regeneration. For this reason, this protocol has been designed with the aim to investigate whether injection in the injection i- pRF with HA can achieve the same improvements of pain and function, compare this technique with arthrocentesis.

Who can participate

Age range20 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of TMJ-ID related symptoms. * Patients suffering from TMJ internal derangement (disc displacement with reduction). * Age limit between 20 and 45years so Patient less than 21years will need assent form …as well as written informed consent from the parents \\guardians. * No previous TMJ surgical procedures * Acquisition of informed consent. * Cooperative patient * Patients free from any systemic disease that may affect the procedure. Exclusion Criteria: * Previous malignant head and neck neoplasms. * Patients suffering from inflammatory or connective tissue systemic diseases. * Neurologic disorders. * History of bony or fibrous adhesion * Gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection. * Patients maintained on anti-coagulants, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks was also excluded in this study. * Uncooperative patient * Pregnant and lactating female. * Patients with systemic diseases (e.g., rheumatoid arthritis, psoriatic arthritis, or juvenile arthritis), and those who had shown symptoms of hypersensitivity to the HA solution.

What they're measuring

pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening

Timeframe: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

Maximum mouth opening

Timeframe: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

Trial details

NCT IDNCT06446843

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-25

View on ClinicalTrials.gov More Internal Derangement trials

Plain-language summary

Who can participate

Age range20 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening

Timeframe: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

Maximum mouth opening

Timeframe: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.