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

Not Applicable

Completed

• Conditions: Mandibular Fracture Trauma; Mandible Fracture

• Registration Number: NCT07058597
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2024-10-01
• Study Completion: 2025-02-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensory nerve function	6 weeks	Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method).

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation for fracture healing	3 months	Preoperative CT scan will be obtained, immediate CT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another CT will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt