TMJ Internal DerangementNCT06867744
Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique
A study testing Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction in people with TMJ Internal Derangement and TMJ - Dislocation of Temporomandibular Joint, run by Mohamed Moawed Ibrahim Ghoneim, PhD at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 50 years
- Conditions the study is for
- TMJ Internal Derangement, TMJ - Dislocation of Temporomandibular Joint, TMJ - Oral &Maxillofacial Surgery
- What is being tested?
- Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Age less than 11 years old
- Age more than 50 years are excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University, Faculty of Medicine, University Hospital
Menoufia
About this study
Official title: 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.
Read the 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.
- Conditions
- TMJ Internal Derangement, TMJ - Dislocation of Temporomandibular Joint, TMJ - Oral &Maxillofacial Surgery
- Being tested
- Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction
- Keywords
- TMJ, TMJ derangement, extracapsular surgery, supradiscal subperiosteal technique, facial plastic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement CorrectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ Pain
change of pain on a visual analogue scale (VAS) from 0 to 10 with decreased number means less pain
Measured: 3 months
Interincisal Distance Score
Interincisal Distance Scores from score-0 to score-3 to be identified
Measured: 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
Measured: 3 days
Clicking
The clicking during mouth opening scores among study participants, both pre- and postoperative
Measured: 3 months
HIT-6
the Headache impact test (HIT-6) both pre- and postoperatively among study participants
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Internal DerangementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Moawed Ibrahim Ghoneim, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University, Sinai University
- Responsible party
- Sponsor-investigator, Mohamed Moawed Ibrahim Ghoneim, PhD, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867744
- Sponsor's protocol ID
- OMS 1-10-023
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique''
- ClinicalTrials.gov ID
- NCT06867744
- Acronym / sponsor ID
- OMS 1-10-023
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mohamed Moawed Ibrahim Ghoneim, PhDUniversity, hospital or other
- Collaborators
- Menoufia University, Sinai University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular Joint Internal Derangement Correction | Other | Procedure: Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement CorrectionThe 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 may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Age less than 11 years old
- Age more than 50 years are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement CorrectionPatients 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 | Procedure or surgery | Temporomandibular Joint Internal Derangement Correction |
Primary outcome
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
Interincisal Distance Score
Time frame: pre- and post operative (3 days)
Interincisal Distance Scores from score-0 to score-3 to be identified
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
Clicking
Time frame: 3 months
The clicking during mouth opening scores among study participants, both pre- and postoperative
HIT-6
Time frame: 3 days
the Headache impact test (HIT-6) both pre- and postoperatively among study participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction in people with TMJ Internal Derangement and TMJ - Dislocation of Temporomandibular Joint, run by Mohamed Moawed Ibrahim Ghoneim, PhD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMJ Pain (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.