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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Procedure: Pterygomaxillary disjunction with interposition Y-shape plate

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pterygomaxillary disjunction

Procedure: Pterygomaxillary disjunction with interposition Y-shape plate; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: TMD_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No