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NCT Number: NCT06657118

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

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.

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Key information

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ultrasound guided arthrocentesis of tempromandibular joint

Procedure
  • 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

Conventional anatomically guided arthrocentesis of tempromandibular joint

Procedure
  • 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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Operation time

    Time frame: Once during every procedure

    Operation time will be measured using stopwatch and recorded in minutes

Study contacts

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

Moataz Bahaa, Lecturer

CONTACT

[email protected]

+201005609359

Samiha Abdelsalam Abdelaziz

CONTACT

[email protected]

+201100791990

Sponsors and collaborators

Lead sponsor

Samiha Abdelsalam Abdelaziz Abdelaziz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Aug 6, 2025

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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