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

April 9, 2026 updated by: Sami faiz kahwaji, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

18

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 Contact Backup

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

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound guided platelet rich fibrin injection.
Patient receive PRF injection under ultrasound guidance
Device: ultrasound guided platelet rich fibrin injection
  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.
Experimental: Arthroscopic guided platelet-rich fibrin injection.
Patient receive PRF injection under arsothscopic guidance
Device: Arthroscopic guided platelet rich Fibrin injection
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

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

Sponsor

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

  • González LV, López JP, Díaz-Báez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Cranio-Maxillofac Surg. 2021;49:1162-1168.
  • Chaudhary FA, Ahmad B, Butt DQ, Hameed S, Bashir U. Normal range of maximum mouth opening in Pakistani population: A cross-sectional study. J Int Oral Health. 2019;11(6):353-356. doi:10.4103/jioh.jioh_127_19.

Helpful Links

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)

May 7, 2026

Primary Completion (Estimated)

February 7, 2027

Study Completion (Estimated)

June 7, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMFS-TMJ-PRF-RCT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing plan at this time due to data sensitivity, ongoing sponsor review, and lack of established infrastructure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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