Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures

NCT ID: NCT07103590

Last Updated: 2025-08-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2025-12-01

Brief Summary

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Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.

Detailed Description

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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

NONE

Study Groups

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Test Group

Group Type EXPERIMENTAL

single Sagittal Split plate

Intervention Type PROCEDURE

patients will be treated using a single Sagittal Split plate at the neutral zone of mandible

Conventional Group

Group Type ACTIVE_COMPARATOR

two conventional miniplates

Intervention Type PROCEDURE

patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

Interventions

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single Sagittal Split plate

patients will be treated using a single Sagittal Split plate at the neutral zone of mandible

Intervention Type PROCEDURE

two conventional miniplates

patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from recent, uninfected angle mandibular fracture.
* Fracture that demands open reduction and internal fixation.

Exclusion Criteria

* Medically compromised patients contradicting the operation.
* Existence of infection at the fracture line.
* Pathological fracture.
* An old fracture.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Peter Naeem El Masry, BDS

Role: CONTACT

0 12 87142534 ext. +2

Facility Contacts

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Peter Naeem El Masry, BDS

Role: primary

Other Identifiers

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1026-1/2025

Identifier Type: -

Identifier Source: org_study_id

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