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NCT Number: NCT07316790

Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection

A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.

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Key information

Conditions

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

facility of Dentistry

Cairo, Old Cairo, 12613, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
  • TMJ pain at rest and/or during function for ≥ 3 months
  • Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
  • Baseline pain intensity ≥ 4/10 on VAS or NRS
  • Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
  • Failed or insufficient response to conservative therapy for ≥ 4-6 weeks (e.g., soft diet, NSAIDs, splint therapy, physiotherapy)
  • Ability to provide informed consent and comply with scheduled follow-up visits

Exclusion criteria

  • Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
  • TMJ ankylosis, fracture, tumor, or active infection
  • Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
  • Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
  • Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
  • Pregnancy or lactation
  • Bleeding disorders, platelet disorders, or anticoagulant therapy that cannot be safely managed (particularly relevant for PRP injections)
  • Known allergy or contraindication to the planned injectate or local anesthetic
  • Severe uncontrolled systemic disease (ASA III-IV) or inability to tolerate anesthesia or sedation (for arthroscopy arm)
  • Active psychiatric or neurologic condition that may impair accurate pain reporting or follow-up compliance

Treatment and study plan

Arthroscopic retrodiscal tissue injection

Procedure

Arthroscopic retrodiscal tissue injection

Ultrasound-guided retrodiscal tissue injection

Procedure

Ultrasound-guided retrodiscal tissue injection

Primary outcomes

  1. Pain intensity (VAS)

    Time frame: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)

    Change in TMJ pain score measured on a 10-cm Visual Analogue Scale (0 = no pain, 10 = worst pain) from baseline to 3 months post-intervention.

Study contacts

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

wajmah SA Al Sayed, phd

CONTACT

[email protected]

0509560055

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 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.