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NCT Number: NCT07535073

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Internal derangements of the temporomandibular joint, particularly disc displacement with reduction, represent a significant proportion of temporomandibular disorders. Conventional conservative treatments may not always achieve satisfactory symptom resolution, leading to increased interest in minimally invasive interventions. PRF has gained attention for its ability to promote tissue regeneration, reduce inflammation, and enhance healing through the sustained release of growth factors. Image-guided injection techniques are essential for ensuring accurate delivery of PRF into the targeted joint structures. Arthroscopic-guided injection allows direct visualization of intra-articular anatomy but is invasive, technically demanding, and associated with higher cost and procedural complexity. In contrast, ultrasound-guided injection is a non-invasive, radiation-free, and cost- effective technique that enables real-time visualization of soft tissues and needle placement. Despite these advantages, the comparative clinical efficacy of ultrasound-guided versus arthroscopic-guided PRF injection remains inadequately explored, particularly in patients with TMJ disc displacement with reduction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Symptoms persisting for at least 3 months.
  • Failure of conservative treatment (e.g. occlusal splint, physiotherapy, NSAIDs). -Ability to understand the study protocol and provide informed consent.

Exclusion criteria

  • 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.
  • Active local infection at the injection site.
  • Pregnancy or lactation.
  • Severe degenerative joint disease (advanced osteoarthritis).
  • Known allergy or contraindication to ( PRF) preparation.

Treatment and study plan

ultrasound guided platelet rich fibrin injection

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

Arthroscopic guided platelet rich Fibrin injection

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

Primary outcomes

  1. Maximum mouth opening

    Time frame: 6 months

    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.

Secondary outcomes

  1. Pain intensity

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Khalid Atef Elhayes, PhD

CONTACT

[email protected]

+20 1030000360

Sami Faiz Kahwaji, DDS

CONTACT

[email protected]

+20 1096094940

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Ultrasound Guided Versus Arthroscopic Guided PRF Injection in Management of Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Clinical Trials

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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