Back to resultsPterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pterygomaxillary disjunction with interposition Y-shape plate
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
Eligibility Criteria
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.
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pterygomaxillary disjunction
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
disc position
MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.
Secondary Outcome Measures
Full Information
NCT ID
NCT05561465
First Posted
September 27, 2022
Last Updated
September 27, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05561465
Brief Title
Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pterygomaxillary disjunction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pterygomaxillary disjunction with interposition Y-shape plate
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in wound healing
Description
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.
Time Frame
1st week and 2nd week
Title
Change in TMJ clinical dysfunction
Description
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.
Time Frame
1st week, 2nd week, 1 month, and 3 months
Title
disc position
Description
MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
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