- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403708
Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture
Retromandibular Transparotid Approach Versus Transmasseteric Anteroparotid Approach for Fixation of Subcondylar Fracture: Randomized Controlled Clinical Study
Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications.
Closed reduction may have late complications, the preference started to change towards open treatment. A Transmasseteric Anteroparotid (TMAP) approach for open treatment of condylar fractures overcomes the problems of facial nerve injury of other approaches. Aim: Comparing the Transmasseteric Antroparotid approach(TMAP) to the Transparotid (TP) approach in management of subcondylar fractures regarding the facial nerve affection, parotid fistula, reduction angulation, pain, duration of the surgery, occlusion and patient satisfaction with the scar. Materials and Methods: Twenty patients with subcondylar fracture will be divided randomly into two equal groups. Group1(study group): Transmasseteric Antroparotid approach. Group2 (control group): Retromandibular Transparotid approach. Patients will be followed up for 3 months to assess facial nerve injury, pain, occlusion and patient's scar satisfaction . Results: data will be collected, tabulated and statistically analysed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt
- Alexandria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including:
Difficulty of obtaining adequate occlusion by closed method. Radiological signs of the following:
- Deviation of the he fragments from the axis of the ascending ramus in medial or lateral direction more than 10°. (28)
- Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.
- Dislocation of the condyle from the glenoid fossa.
Exclusion Criteria:
- Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems. 2. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: transmasseteric anteroparotid approach
|
safer approach for condylar fracture
|
|
Active Comparator: transparotid approach
|
facial nerve and parotid dissection to reach condyle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
facial nerve injury
Time Frame: immediate postoperative
|
immediate postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
approach time
Time Frame: interaoperative
|
interaoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0841-01/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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