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NCT Number: NCT06867744

Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique

This study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

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Key information

Conditions

TMJ Internal Derangement TMJ - Dislocation of Temporomandibular Joint TMJ - Oral &Maxillofacial Surgery

Age range

11 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University, Faculty of Medicine, University Hospital

Menoufia, Egypt

About this study

Background: Internal derangement (ID) of the temporomandibular joint (TMJ) is a prevalent condition characterized by disc displacement, leading to pain, restricted mandibular mobility, and reduced quality of life. While non-surgical treatments are often the first line of management, surgical intervention becomes necessary in refractory cases. Traditional surgical methods, such as arthrocentesis and disc repositioning, have shown variable success rates, particularly in advanced stages of disc damage. This study introduces the Extracapsular Supradiscal Subperiosteal (ESS) surgical procedure, a novel technique designed to address these limitations. Therefore, current study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

Patients and Methods: A prospective study was conducted on 50 patients (47 females, 3 males; age range: 11-50 years) with TMJ ID refractory to non-surgical management. The ESS procedure was performed to reposition the displaced disc and stabilize retrodiscal tissues without violating the joint capsule. Preoperative and postoperative assessments included pain levels, maximum mouth opening (MMO), and subjective patient feedback.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with stage 3 or stage 4 internal derangements of TMJ radiological and clinical findings should coincide to set up the diagnosis and predict the treatment plan.

Exclusion criteria

  • Age less than 11 years old
  • Age more than 50 years are excluded

Treatment and study plan

Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction

Procedure

Patients in a supine extended position with nasotracheal intubation; oral intubation in such cases is not suitable as it makes dissection and disc repositioning difficult and compromises the surgery results. Periauricular incision with postauricular extension; after infiltration with noradrenaline 1/200000 solution with or without zylocaine which gives better exposure and better aesthetic results. Dissection down the wound till reach the temporal fascia starting posteriorlay till the fascia blended with the zygomatic arch anteriorly; identification of temporal root of zygomatic arch using fine dissector followed by subperiosteal dissection of zygomatic arch till five mm anterior to the articular eminence of TMJ. Accurate identification of TMJ followed by meticulous subperiosteal dissection of superior margin of TMJ capsule then the dissection continued posteriorly till posterior margin; no need to dissect the bilaminar zone, and the dissection continued anteriorly down the skull base t

Primary outcomes

  1. TMJ Pain

    Time frame: 3 months

    change of pain on a visual analogue scale (VAS) from 0 to 10 with decreased number means less pain

  2. Interincisal Distance Score

    Time frame: pre- and post operative (3 days)

    Interincisal Distance Scores from score-0 to score-3 to be identified

  3. Jaw deviation during Mouth Opening

    Time frame: 3 days

    A 13-score evaluating the jaw deviation during mouth opening from score-0 to score-12

  4. Clicking

    Time frame: 3 months

    The clicking during mouth opening scores among study participants, both pre- and postoperative

  5. HIT-6

    Time frame: 3 days

    the Headache impact test (HIT-6) both pre- and postoperatively among study participants

Sponsors and collaborators

Lead sponsor

Mohamed Moawed Ibrahim Ghoneim, PhD

Other

Collaborators

  • Menoufia University
  • Sinai University

Registry information

Official study title

Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique''

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 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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