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

Not Applicable

Completed

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

• Registration Number: NCT06867744
• Lead Sponsor: Mohamed Moawed Ibrahim Ghoneim, PhD

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
TMJ Pain	3 months	change of pain on a visual analogue scale (VAS) from 0 to 10 with decreased number means less pain
Clicking	3 months	The clicking during mouth opening scores among study participants, both pre- and postoperative
Interincisal Distance Score	pre- and post operative (3 days)	Interincisal Distance Scores from score-0 to score-3 to be identified
Jaw deviation during Mouth Opening	3 days	A 13-score evaluating the jaw deviation during mouth opening from score-0 to score-12
HIT-6	3 days	the Headache impact test (HIT-6) both pre- and postoperatively among study participants

Trial Locations

Locations (1)

Menoufia University, Faculty of Medicine, University Hospital; 🇪🇬 Menoufia, Egypt