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NCT Number: NCT06333197

Approaches 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).

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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ORIF through transparotid approach

Procedure

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

Procedure

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

Primary outcomes

  1. Facial nerve injury

    Time frame: Up to 6 months

    Incidence of Facial Nerve Injury Following the Manoeuvre. ( Temporary or Permanent )

  2. Operative time

    Time frame: Up to 3 hours

    The duration of the operation

Secondary outcomes

  1. Fracture stability

    Time frame: Up to 3 Months

    Measure the status of bone after reduction

  2. Mouth opening

    Time frame: Up to 3 Months

    Maximal inter incisor opening

  3. Other Complication related to the Approach

    Time frame: Up to 6 Months

    Salivary Fistula, Sialocele, Freys Syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Diaa El-dein Saber, PHD degree

CONTACT

[email protected]

+201007967946

Mustafa Mahmoud Hussien

CONTACT

[email protected]

+201015750092 ext. +201140308095

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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