Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

NCT ID: NCT03747666

Last Updated: 2019-02-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-11-30

Brief Summary

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Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Detailed Description

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Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Conditions

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Mandible Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Locking miniplate

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.

Group Type EXPERIMENTAL

2.0 single locking miniplates

Intervention Type PROCEDURE

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Non-locking miniplates

The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.

Group Type EXPERIMENTAL

2.0 single locking miniplates

Intervention Type PROCEDURE

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Interventions

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2.0 single locking miniplates

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
* Fractures amenable to treatment using intra oral approach.

Exclusion Criteria

* Medically compromised patients who are unfit for the procedure under general anesthesia.
* Patients with comminuted fractures.
* Patients with history of occlusion disturbances or skeletal malocclusion.
* Patients with insufficient dentition to reproduce occlusion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hany Abdelkader Hussein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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30101980

Identifier Type: -

Identifier Source: org_study_id

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