Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

July 29, 2024 updated by: Mustafa Mahmoud Hussien Ahmed, Assiut University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mustafa Mahmoud Hussien
  • Phone Number: +201140308095 +201015750092
  • Email: Urfavdash@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transparotid approch
Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular transparotid approch
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.
Experimental: Retroparotid approch
Patients who diagnosed with extra capsular fracture of mandibular condyle will undergo Retromandibular retroparotid approch
Procedure: 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.
Other Names:
  • ORIF through the Modified Blair Incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial nerve injury
Time Frame: Up to 6 months
Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )
Up to 6 months
Operative time
Time Frame: Up to 3 hours
The duration of the operation
Up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture stability
Time Frame: Up to 3 Months
Measure the status of bone after reduction
Up to 3 Months
Mouth opening
Time Frame: Up to 3 Months
Maximal inter incisor opening
Up to 3 Months
Other Complication related to the Approach
Time Frame: Up to 6 Months
Salivary Fistula, Sialocele, Freys Syndrome
Up to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mandibular condylar fracture

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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