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

Temporomandibular Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561465
• Other study ID #: TMD_2021
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	disc position	MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.	at 3 months