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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-02-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Mandibular Fracture Trauma Mandible Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with with fractures in the anterior transition zone managed with 3 different configurations of miniplates

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator

Study Groups

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

Group Type ACTIVE_COMPARATOR

Twinfork plate

Intervention Type DEVICE

Twinfork plate

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

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

Group Type ACTIVE_COMPARATOR

3D-interlocking plate

Intervention Type DEVICE

3D-interlocking plate

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

Group Type EXPERIMENTAL

Miniplate

Intervention Type DEVICE

Miniplate

Interventions

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Twinfork plate

Intervention Type DEVICE

3D-interlocking plate

Intervention Type DEVICE

Miniplate

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No