Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures

NCT ID: NCT04218058

Last Updated: 2020-01-06

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2019-11-23

Brief Summary

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To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.

To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.

To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.

Detailed Description

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Conditions

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Zygomatic Arch Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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study (ultrasound guided closed reduction of zygomatic arch))

reduction of zygomatic arch guided by ultrasound

Group Type ACTIVE_COMPARATOR

reduction of zygomatic arch in zygomaticomaxillary complex fracture

Intervention Type PROCEDURE

ultrasound guided reduction of zygomatic arch

control (open reduction of zygomatic arch)

open reduction of zygomatic arch through coronal incision

Group Type ACTIVE_COMPARATOR

reduction of zygomatic arch in zygomaticomaxillary complex fracture

Intervention Type PROCEDURE

ultrasound guided reduction of zygomatic arch

Interventions

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reduction of zygomatic arch in zygomaticomaxillary complex fracture

ultrasound guided reduction of zygomatic arch

Intervention Type PROCEDURE

Other Intervention Names

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open reduction of zygomatic arch in zygomaticomaxillary complex fracture

Eligibility Criteria

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Inclusion Criteria

* Patients presenting with ZMC fractures that require reduction and fixation
* Patients between 20 to 50 years old with no gender predilections

Exclusion Criteria

* Existence of infection at the fracture line
* Chronic systemic diseases such as metabolic bone disease, immunocompromised status
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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Tasneem Ahmed Mabrouk Amer

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0020

Identifier Type: -

Identifier Source: org_study_id

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