Temporomandibular Joint Disc DisplacementNCT05804695
Evaluation of the Arthroscopic Temporomandibular Joint Disc Repositioning
A study testing Arthroscopic TMJ disc repositioning under GA in people with Temporomandibular Joint Disc Displacement, run by Future University in Egypt at 1 site in Egypt.
Trial summary
1. Full medical and dental history will be taken from the patient participating in this study. 2. A written consent to be signed by the patient for the potentials of operative and postoperative complications. 3. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Temporomandibular Joint Disc Displacement
- What is being tested?
- Arthroscopic TMJ disc repositioning under GA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 25 Mar 2023
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of TMJ disorder (Pain, limitation and/or locking)
- Unilateral or bilateral TMJ internal derangement Wilkes stage III, IV
- Failed Conservative treatment for two months if it was indicated
- Age between 20- 50 years old
Who cannot join
- Systemic Disease such as uncontrolled Diabetes, uncontrolled hypertension
- Patient who had a previous Intracapsular TMJ surgery
- Tumors and TMJ ankylosis
- Edentulous patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Temporomandibular Joint Disc Repositioning
- Full medical and dental history will be taken from the patient participating in this study.
- A written consent to be signed by the patient for the potentials of operative and postoperative complications.
- The skin is prepared by antiseptic solution then surgical drapes exposing the ear lobule and the outer canthus of the eye. The entry point at maximum convexity of glenoid fossa with palpation technique for primary arthroscopy technique , diagnostic sweep followed by second puncture using triangulation technique
- Discopexy technique to be performed with the following steps : anterior release , disc reduction, retro-discal scarification, and disc fixation using ligature wire and button.
- The trocar then observed on the monitor entering the joint space. Once intra-articular, the trocar should be removed, and drainage of the irrigating fluid through the cannula.
- A hook probe is inserted through the operative cannula. The intra-articular incision begins at the juncture between the pterygoid shadow and the anterior recess then myotomy to the lateral pterygoid muscle is done.
- The operative cannula then "walked back" in the lateral sulcus to the posterior pouch. The condyle should be pulled forward. The disc then reduced by compressing the retrodiscal tissue laterally and inferiorly with a straight probe, with the condyle in a forward or forward and contralateral position.
- Next, Disc fixation should be accomplished using ligation wire. The target area of fixation is the posterior lateral corner of the disc. A suitable gauge needle with a single wire inserted through the skin and subcuticular tissues, touching the condylar head, into the inferior joint space, and then angled superiorly. Once that completed, a straight Meniscus Mender II inserted in the preauricular skin crease 5 to 7 mm below the fossa portal into the superior joint space.
- The snare of the Meniscus Mender was then inserted through the Meniscus Mender cannula, and the ligation wire then passed through the 20-gauge needle anteriorly and caught by the snare to have both ends of the suture exited the skin.
- Small skin incisions should be done at the exit points of the wire superiorly with a no. 11 blade through the skin and subcutaneous tissue. A straight hemostat used to dissect down, tracing anteriorly to the capsule along the course of the facial nerve. Posteriorly, the dissection continued down halfway to the capsule.
- A suitable gauge needle then used to pass the anterior wire through the slit incision, deep to the capsule, and back out to the posterior slit incision, so that both free ends of the ligation wire exiting posteriorly through the posterior slit incision. With the disc held in reduction, a tight surgeon's knot tied plicating the disc to the lateral capsule and holding the disc in a posterior lateral position and buttons then used.
- Finally, the arthroscope used to check the position of the disc under function9.
- Postoperative instructions and medications :
- Analgesics
- Antibiotic coverage
- MRI 6 months postoperative to assess disc reduction
- Follow up appointment one week, one month ,three months and 6 months (Buttons will be removed two weeks postoperatively) To assess the disc position and testing for any facial nerve affection Then, measurements of the maximum mouth opening in millimeters.
- Being tested
- Arthroscopic TMJ disc repositioning under GA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic TMJ disc repositioning under GAProcedure or surgery
a surgical procedure used to treat Tempro- mandibular disc displacement using arthroscope.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Temporo-mandibular joint disc repositioning under General anathesia | Experimental | Not described Receives: Procedure: Arthroscopic TMJ disc repositioning under GA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the measurements of the maximum inter-incisal opening (MIO)
Change in the measurements of the maximum inter-incisal opening (MIO) in millimeter measured by a ruler preoperatively and postoperatively in the follow up appointments.
Measured: pre surgery and after 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start20 Feb 2020
- Primary completion20 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Sameh Abdelaziz, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804695
- Sponsor's protocol ID
- FUE.REC (9)/1-2020
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Temporomandibular Joint Disc Repositioning
- ClinicalTrials.gov ID
- NCT05804695
- Acronym / sponsor ID
- FUE.REC (9)/1-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (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.
- Full medical and dental history will be taken from the patient participating in this study.
- A written consent to be signed by the patient for the potentials of operative and postoperative complications.
- The skin is prepared by antiseptic solution then surgical drapes exposing the ear lobule and the outer canthus of the eye. The entry point at maximum convexity of glenoid fossa with palpation technique for primary arthroscopy technique , diagnostic sweep followed by second puncture using triangulation technique
- Discopexy technique to be performed with the following steps : anterior release , disc reduction, retro-discal scarification, and disc fixation using ligature wire and button.
- The trocar then observed on the monitor entering the joint space. Once intra-articular, the trocar should be removed, and drainage of the irrigating fluid through the cannula.
- A hook probe is inserted through the operative cannula. The intra-articular incision begins at the juncture between the pterygoid shadow and the anterior recess then myotomy to the lateral pterygoid muscle is done.
- The operative cannula then "walked back" in the lateral sulcus to the posterior pouch. The condyle should be pulled forward. The disc then reduced by compressing the retrodiscal tissue laterally and inferiorly with a straight probe, with the condyle in a forward or forward and contralateral position.
- Next, Disc fixation should be accomplished using ligation wire. The target area of fixation is the posterior lateral corner of the disc. A suitable gauge needle with a single wire inserted through the skin and subcuticular tissues, touching the condylar head, into the inferior joint space, and then angled superiorly. Once that completed, a straight Meniscus Mender II inserted in the preauricular skin crease 5 to 7 mm below the fossa portal into the superior joint space.
- The snare of the Meniscus Mender was then inserted through the Meniscus Mender cannula, and the ligation wire then passed through the 20-gauge needle anteriorly and caught by the snare to have both ends of the suture exited the skin.
- Small skin incisions should be done at the exit points of the wire superiorly with a no. 11 blade through the skin and subcutaneous tissue. A straight hemostat used to dissect down, tracing anteriorly to the capsule along the course of the facial nerve. Posteriorly, the dissection continued down halfway to the capsule.
- A suitable gauge needle then used to pass the anterior wire through the slit incision, deep to the capsule, and back out to the posterior slit incision, so that both free ends of the ligation wire exiting posteriorly through the posterior slit incision. With the disc held in reduction, a tight surgeon's knot tied plicating the disc to the lateral capsule and holding the disc in a posterior lateral position and buttons then used.
- Finally, the arthroscope used to check the position of the disc under function9.
- Postoperative instructions and medications :
- Analgesics
- Antibiotic coverage
- MRI 6 months postoperative to assess disc reduction
- Follow up appointment one week, one month ,three months and 6 months (Buttons will be removed two weeks postoperatively) To assess the disc position and testing for any facial nerve affection Then, measurements of the maximum mouth opening in millimeters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Temporo-mandibular joint disc repositioning under General anathesia | Experimental | Procedure: Arthroscopic TMJ disc repositioning under GA |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of TMJ disorder (Pain, limitation and/or locking)
- Unilateral or bilateral TMJ internal derangement Wilkes stage III, IV
- Failed Conservative treatment for two months if it was indicated
- Age between 20- 50 years old
Key exclusion criteria (4 listed)
- Systemic Disease such as uncontrolled Diabetes, uncontrolled hypertension
- Patient who had a previous Intracapsular TMJ surgery
- Tumors and TMJ ankylosis
- Edentulous patients
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 |
|---|---|---|
| Arthroscopic TMJ disc repositioning under GAa surgical procedure used to treat Tempro- mandibular disc displacement using arthroscope. | Procedure or surgery | Arthroscopic Temporo-mandibular joint disc repositioning under General anathesia |
Primary outcome
Change in the measurements of the maximum inter-incisal opening (MIO)
Time frame: pre surgery and after 6 months from surgery
Change in the measurements of the maximum inter-incisal opening (MIO) in millimeter measured by a ruler preoperatively and postoperatively in the follow up appointments.
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 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Arthroscopic TMJ disc repositioning under GA in people with Temporomandibular Joint Disc Displacement, run by Future University in Egypt 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 4 inclusion and 4 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 7 Apr 2023. 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?
Change in the measurements of the maximum inter-incisal opening (MIO) (time frame: pre surgery and after 6 months from surgery). 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 7 Apr 2023.