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

January 2, 2026 updated by: Wajmah Sayed Karim Al Sayed, Cairo University

Comparative 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Old Cairo
      • Cairo, Old Cairo, Egypt, 12613
        • facility of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arthroscopic Retrodiscal Tissue Injection
Procedure: Arthroscopic retrodiscal tissue injection
Arthroscopic retrodiscal tissue injection
Active Comparator: Ultrasound-Guided Retrodiscal Tissue Injection
Procedure: Ultrasound-guided retrodiscal tissue injection
Ultrasound-guided retrodiscal tissue injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Niveen AL Asker, Prof, Cairo University
  • Study Director: Niveen AL Asker, Prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 13, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • arthroscope versus ultrasound

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) generated during this study will be made available to other researchers upon reasonable request. The shared IPD will include baseline demographic data, clinical diagnosis, intervention allocation, pain scores (VAS), maximum mouth opening measurements, and follow-up outcome data at predefined time points. All shared data will be anonymized to ensure participant confidentiality, and no direct identifiers will be disclosed. Data will be available after publication of the primary study results and may be used for academic and non-commercial research purposes following approval by the study investigators.

IPD Sharing Time Frame

by the end of May 2026 will be available

IPD Sharing Access Criteria

throw the free publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroscopic retrodiscal tissue injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe