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NCT06333197 Clinical Trial

Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

Mandibular Fractures Clinical Trial

Official title:
A Comparative Study Between the Retromandibular Transparotid Approach and Retromandibular Retroparotid Approach for Open Reduction and Internal Fixation of Mandibular Condylar Fracture.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06333197
Other study ID # Mandibular condylar fracture
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date July 1, 2025

Study information
Verified date March 2024
Source Assiut University
Contact Mustafa Mahmoud Hussien
Phone +201015750092
Email Urfavdash@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The condylar region is the most frequent anatomical site for mandibular fractures . Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

Description:

Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches. The selection of the appropriate surgical approach for condylar neck fracture represents a controversy. The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery. Exclusion Criteria: - 1. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ORIF through transparotid approach
The Retromandibular Transparotid approach is a surgical method used to access structures in the parotid gland region by making an incision behind the mandible.
• ORIF through retroparotid approach
The Retromandibular Retroparotid approach, also known as the Modified Blair Incision, is a surgical technique used to access structures within the parotid gland region by creating an incision behind the mandible and extending it into the parotid region.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Facial nerve injury Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent ) Up to 6 months
Primary Operative time The duration of the operation Up to 3 hours
Secondary Fracture stability Measure the status of bone after reduction Up to 3 Months
Secondary Mouth opening Maximal inter incisor opening Up to 3 Months
Secondary Other Complication related to the Approach Salivary Fistula, Sialocele, Freys Syndrome Up to 6 Months
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