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

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Completed
CT.gov ID
NCT05561465
Collaborator
(none)
12
1
1
7.9
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pterygomaxillary disjunction with interposition Y-shape plate
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. disc position [at 3 months]

    MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University Alexandria Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT05561465
Other Study ID Numbers:
  • TMD_2021
First Posted:
Sep 30, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2022