Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.

August 2, 2025 updated by: Samiha Abdelsalam Abdelaziz Abdelaziz

Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial

The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
  • Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • ASA 1-2 patients with no contraindications for GA
  • Patients who did not respond to conservative treatment.

Exclusion Criteria:

  • Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
  • Handicaps and special needs patients.
  • Prisoners.

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
Active Comparator: Conventional arthrocentesis
  • Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
  • Head turned to the affected side.
  • External auditory meatus will be blocked with a cotton plug.
  • A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.
  • Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.

Intra-operative procedures - continued in both groups:

  • Lavage is performed with 100 ml of saline solution.
  • 1 ml of Hyaluronic acid is injected into the superior joint space.
  • Puncture point is covered with sterile dressing for 24 hours
Procedure: Conventional anatomically guided arthrocentesis of tempromandibular joint
  • Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
  • Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.
  • A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.
  • Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.

Intra-operative procedures - continued in both groups:

  • Lavage is performed with 100 ml of saline solution.
  • 1 ml of Hyaluronic acid is injected into the superior joint space.
  • Puncture point is covered with sterile dressing for 24 hours
Active Comparator: Ultrasound guided arthrocentesis

Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.

  • Head turned to the affected side.
  • External auditory meatus will be blocked with a cotton plug.
  • Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.
  • Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.
  • Superior joint space located between the disc and articular eminence is the targeted point of the needle.

Intra-operative procedures - continued in both groups:

  • Lavage is performed with 100 ml of saline solution.
  • 1 ml of Hyaluronic acid is injected into the superior joint space.
  • Puncture point is covered with sterile dressing for 24 hours
Procedure: Ultrasound guided arthrocentesis of tempromandibular joint
  • Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
  • Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.
  • Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.
  • Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.
  • Superior joint space located between the disc and articular eminence is the targeted point of the needle.

Intra-operative procedures - continued in both groups:

  • Lavage is performed with 100 ml of saline solution.
  • 1 ml of Hyaluronic acid is injected into the superior joint space.
  • Puncture point is covered with sterile dressing for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening
Time Frame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler
Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Joint pain
Time Frame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.
Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: Once during every procedure
Operation time will be measured using stopwatch and recorded in minutes
Once during every procedure

Collaborators and Investigators

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

Sponsor

Samiha Abdelsalam Abdelaziz Abdelaziz

Investigators

  • Study Director: Gamal Moutaed, Professor, 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)

October 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 2, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US guided arthrocentesis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

share it with other researchers websites if it is possible

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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