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

NCT05561465 | Completed

• 1 other identifier: TMD_2021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Pterygomaxillary disjunction

EXPERIMENTAL

Procedure: Pterygomaxillary disjunction with interposition Y-shape plate

Interventions

Pterygomaxillary disjunction with interposition Y-shape plate PROCEDURE

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

Pterygomaxillary disjunction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

EG (1)