Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations

Alexandria University

Status: Completed

Conditions: Mandibular Fracture Trauma; Mandible Fracture

Treatments: Device: 3D-interlocking plate; Device: Miniplate; Device: Twinfork plate

Study type: Interventional

Funder types: Other

Identifiers

NCT07058597

AMTZ-3G-2025

Details and patient eligibility

About

Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates

Full description

A total of 36 patients (they were divided into three groups 16 patients in each group ) with parasymphyseal-body fractures , one group was treated with twin-fork miniplate , the second group was treated using 3d interlocking miniplate and the third one was treated with conventional two miniplates. Postoperative evaluation of the mental nerve was conducted using both subjective and objective methods at intervals of 24 hours, and at 1, 4, 6 and 12 weeks. Furthermore, an electrophysiological study was performed at 6 weeks postoperatively to measure the mental nerve's amplitude, onset latency and conduction velocity

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible
• Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months.
• A fracture that demands open reduction and internal fixation.
• The patient medically fit for general anesthesia.

Exclusion criteria

• Medically compromised patients contradicting operation.
• Pathological fracture.
• An old fracture.
• Completely edentulous patient.
• Patients with frank infection.
• Patients with a comminuted fracture.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate

Active Comparator group

Description:

Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate

Treatment:

Device: Twinfork plate

Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking

Active Comparator group

Description:

Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking plate

Treatment:

Device: 3D-interlocking plate

Patients with mandibular fracture in the anterior transition zone managed with miniplates

Experimental group

Description:

Patients with mandibular fracture in the anterior transition zone managed with miniplates

Treatment:

Device: Miniplate