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

NCT06867744 | Completed DMC

• 1 other identifier: OMS 1-10-023
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

TMJ; TMJ derangement; extracapsular surgery; supradiscal subperiosteal technique; facial plastic surgery

Outcome Measures

Primary Outcomes (5)

• TMJ Pain

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

  3 months

• Interincisal Distance Score

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

  pre- and post operative (3 days)

• Jaw deviation during Mouth Opening

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

  3 days

• Clicking

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

  3 months

• HIT-6

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

  3 days

Study Arms (1)

Temporomandibular Joint Internal Derangement Correction

OTHER

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.

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

Interventions

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

Temporomandibular Joint Internal Derangement Correction

Eligibility Criteria

• Age: 11 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mohamed Moawed Ibrahim Ghoneim, PhD: lead
• Menoufia University: collaborator
• Sinai University: collaborator

Study Sites (1)

Menoufia University, Faculty of Medicine, University Hospital

Menoufia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: January 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

EG (1)