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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

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