Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures

NCT ID: NCT04396054

Last Updated: 2020-05-20

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-02-20

Brief Summary

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This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

Detailed Description

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This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.

Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.

Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Conditions

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Mandibular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lag Screws

Group 1: underwent open reduction and internal fixation using two lag screws.

Group Type ACTIVE_COMPARATOR

Lag Screws

Intervention Type DEVICE

Method of internal fixation

Double Y-shaped plates

Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Group Type ACTIVE_COMPARATOR

double Y-shaped plates

Intervention Type DEVICE

Method of internal fixation

Interventions

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Lag Screws

Method of internal fixation

Intervention Type DEVICE

double Y-shaped plates

Method of internal fixation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients of both genders
* with age ranging from 25 to 45 years,
* suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

Exclusion Criteria

* old fractures,
* infected fractures
* comminuted fractures
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lydia Nabil

OTHER

Sponsor Role lead

Responsible Party

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Lydia Nabil

Assistant Professor of Oral and Maxillofacial Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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UAlexandriaDentSurg1

Identifier Type: -

Identifier Source: org_study_id

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