- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867744
Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique
Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique''
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Menoufia, Egypt
- Menoufia University, Faculty of Medicine, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Temporomandibular Joint Internal Derangement Correction
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TMJ Pain
Time Frame: 3 months
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change of pain on a visual analogue scale (VAS) from 0 to 10 with decreased number means less pain
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3 months
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Interincisal Distance Score
Time Frame: pre- and post operative (3 days)
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Interincisal Distance Scores from score-0 to score-3 to be identified
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pre- and post operative (3 days)
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Jaw deviation during Mouth Opening
Time Frame: 3 days
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A 13-score evaluating the jaw deviation during mouth opening from score-0 to score-12
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3 days
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Clicking
Time Frame: 3 months
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The clicking during mouth opening scores among study participants, both pre- and postoperative
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3 months
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HIT-6
Time Frame: 3 days
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the Headache impact test (HIT-6) both pre- and postoperatively among study participants
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3 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMS 1-10-023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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