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

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Procedure: Pterygomaxillary disjunction with interposition Y-shape plate

• Registration Number: NCT05561465
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pterygomaxillary disjunction	Pterygomaxillary disjunction with interposition Y-shape plate	-

Primary Outcome Measures

Name	Time	Method
Change in wound healing	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	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	at 3 months	MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt