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Completed

NCT Number: NCT07058597

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Twinfork plate

Device

Twinfork plate

3D-interlocking plate

Device

3D-interlocking plate

Miniplate

Device

Miniplate

Primary outcomes

  1. Sensory nerve function

    Time frame: 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 outcomes

  1. Radiographic evaluation for fracture healing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Assessment of Mental Nerve Integrity During Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

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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