Ultrasound-guided Versus Arthroscopic Guided PRF Injection for TMJ Disc Displacement.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-60 years.

Clinically and radiographically diagnosed temporomandibular joint disc displacemet with reduction.

Presence of TMJ pain exacerbated by mandibular movement.

Limited mandibular function and/or reduced maximum mouth opening.

Disqualifiers

Previous TMJ surgery or arthroscopic intervention.

Intra-articular injection in the TMJ within the last 6 months.

Systemic inflammatory or autoimmune joint diseases.

Coagulation disorders or current anticoagulant therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound guided platelet rich fibrin injection

    Device

    1. A high-frequency linear ultrasound probe will be used to identify the TMJ space. 2. A sterile syringe containing 1 mL of PRF will be inserted into the superior joint space under real-time ultrasound guidance. 3. PRF will be injected slowly with continuous confirmation of needle position.

  • Arthroscopic guided platelet rich Fibrin injection

    Device

    1. TMJ arthroscopy will be performed under local or general anesthesia following standard aseptic preparation. 2. The superior joint space will be visualized using a 1.9 mm arthroscope. 3. A sterile syringe containing 1 mL of PRF will be introduced through a lateral portal under direct arthroscopic visualization. 4. PRF will be injected slowly into the superior joint space.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Ultrasound guided platelet rich fibrin injection.Experimental treatment 1 intervention
Group B: Arthroscopic guided platelet-rich fibrin injection.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum mouth opening

Maximum interincisal distance measured using digital caliper in millimeters (mm) between upper and lower central incisors, Unit of measure: millimeters (mm). Minimum value: 0 mm. Maximum value: 60 mm. Higher values represent a better outcome.

Time frame
6 months

Secondary outcomes

1

Pain intensity

Pain intensity assessed using 100 mm Visual Analog Scale (VAS). 0 = no pain; 10 = worst pain imaginable. Unit of measure: points (0-10). Minimum value: 0. Maximum value: 10. Higher scores represent a worse outcome.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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