Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Pterygomaxillary Disjunction With Interpositional Y-shape Plate as an Innovative Minimally Invasive Technique in Patients With Temporomandibular Joint Internal Derangement (Clinical Trial)

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Procedure: Pterygomaxillary disjunction with interposition Y-shape plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pterygomaxillary disjunction<br> | Procedure: Pterygomaxillary disjunction with interposition Y-shape plate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | at 3 months |