Temporomandibular DisorderNCT05561465
Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
A study testing Pterygomaxillary disjunction with interposition Y-shape plate in people with Temporomandibular Disorder, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Pterygomaxillary disjunction with interposition Y-shape plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 Jun 2022
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients without relevant disease
- Patients refractory to conservative treatment > 6 months.
- Patients are diagnosed, with unilateral/bilateral anterior disc displacement without reduction, clinically and by MRI recently.
- No previous TMJ surgery.
- No previous maxillofacial trauma.
Who cannot join
- Patients with systemic joint disease (rheumatoid, osteoarthritis, gouts).
- Medically compromised patients contraindicating operation.
- Patients to whom general anesthesia is contraindicated.
- Patient with neuromuscular disorders.
- Patients with any gross pathology of the ear.
- Patient with psychoneurotic disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Evaluation of Pterygomaxillary Disjunction With Interpositional Y-shape Plate as an Innovative Minimally Invasive Technique in Patients With Temporomandibular Joint Internal Derangement (Clinical Trial)
Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Surgical intervention is a controversial issue in cases not responding to conservative methods. A novel minimally invasive surgical technique which is extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally invasive extracapsular technique that preserves TMJ integrity.
- Conditions
- Temporomandibular Disorder
- Being tested
- Pterygomaxillary disjunction with interposition Y-shape plate
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterygomaxillary disjunction with interposition Y-shape plateProcedure or surgery
All patients will be treated under general anesthesia. The pterygoid plate will be fractured, pried up, and pushed backward. A Y-shape plate will be fixed to the lateral maxillary surface with its vertical limb and the other two limbs are turned to fit into the retro maxillary space preventing the reattachment of the fractured pterygoid plate
| Study group | Role | What they receive |
|---|---|---|
| Pterygomaxillary disjunction | Experimental | Not described Receives: Procedure: Pterygomaxillary disjunction with interposition Y-shape plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound healing
The sutured wounds will be examined after one and two weeks for signs and symptoms of infection including swelling, redness, hotness, pus discharge, and pain in addition to observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure.
Measured: 1st week and 2nd week
Change in TMJ clinical dysfunction
Helkimo's dysfunction index is used, including the interincisal opening of the mandible, deviation during the opening, dysfunction of TMJ, pain in the TMJ and preauricular region, and also masticatory muscles were palpated for pain during the follow-up periods.
Measured: 1st week, 2nd week, 1 month, and 3 months
disc position
MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561465
- Sponsor's protocol ID
- TMD_2021
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pterygomaxillary Disjunction With Interpositional Y-shape Plate as an Innovative Minimally Invasive Technique in Patients With Temporomandibular Joint Internal Derangement (Clinical Trial)
- ClinicalTrials.gov ID
- NCT05561465
- Acronym / sponsor ID
- TMD_2021
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Sep 2022 (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.
Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Surgical intervention is a controversial issue in cases not responding to conservative methods. A novel minimally invasive surgical technique which is extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally invasive extracapsular technique that preserves TMJ integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pterygomaxillary disjunction | Experimental | Procedure: Pterygomaxillary disjunction with interposition Y-shape plate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients without relevant disease
- Patients refractory to conservative treatment > 6 months.
- Patients are diagnosed, with unilateral/bilateral anterior disc displacement without reduction, clinically and by MRI recently.
- No previous TMJ surgery.
- No previous maxillofacial trauma.
Key exclusion criteria (6 listed)
- Patients with systemic joint disease (rheumatoid, osteoarthritis, gouts).
- Medically compromised patients contraindicating operation.
- Patients to whom general anesthesia is contraindicated.
- Patient with neuromuscular disorders.
- Patients with any gross pathology of the ear.
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 |
|---|---|---|
| Pterygomaxillary disjunction with interposition Y-shape plateAll patients will be treated under general anesthesia. The pterygoid plate will be fractured, pried up, and pushed backward. A Y-shape plate will be fixed to the lateral maxillary surface with its vertical limb and the other two limbs are turned to fit into the retro maxillary space preventing the reattachment of the fractured pterygoid plate | Procedure or surgery | Pterygomaxillary disjunction |
Primary outcome
Change in wound healing
Time frame: 1st week and 2nd week
The sutured wounds will be examined after one and two weeks for signs and symptoms of infection including swelling, redness, hotness, pus discharge, and pain in addition to observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure.
Change in TMJ clinical dysfunction
Time frame: 1st week, 2nd week, 1 month, and 3 months
Helkimo's dysfunction index is used, including the interincisal opening of the mandible, deviation during the opening, dysfunction of TMJ, pain in the TMJ and preauricular region, and also masticatory muscles were palpated for pain during the follow-up periods.
disc position
Time frame: at 3 months
MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.
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 30 Sep 2022.
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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 Pterygomaxillary disjunction with interposition Y-shape plate in people with Temporomandibular Disorder, run by Hams Hamed Abdelrahman 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 5 inclusion and 6 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 30 Sep 2022. 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 wound healing (time frame: 1st week and 2nd week). The study lists 3 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 30 Sep 2022.