The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant

May 3, 2025 updated by: mona samy sheta, Tanta University

The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study

under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 3111
        • Faculty of Dentistry, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion Criteria:

  • systemic disease interfere with bone healing enophthamous less than 2 mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prebent titanium mesh
reconstruction of fractured orbital walls with perbent titanium mesh
Device: reconstruction of orbital walls
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
Experimental: customized titanium implant (patient specific implant)
econstruction of fractured orbital walls with patient specific implant (customized titanium implant)
Device: reconstruction of orbital walls
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
restoring the accurate position of eye
Time Frame: one month- six months
using exophthalmometer to measure enophthalmous
one month- six months
motility of eye
Time Frame: one month
using 9 gaze test to evaluate motility of eye
one month
volume of orbit
Time Frame: one to six months
using CT scan to measure orbital volume pre and postoperative
one to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: mona s sheta, lecturer, Tanta university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Actual)

May 18, 2024

Study Completion (Actual)

December 6, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 (Other Grant/Funding Number: Rome Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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