Suspended
Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
What is being tested
3D printed PEEK onlay
+ Pre-bent orbital mesh
Combination Product
Who is being recruted
Eye Diseases+9
+ Facial Injuries
+ Craniocerebral Trauma
Over 17 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: March 2020
Summary
Principal SponsorCairo University
Study ContactKhalid Amr, PhD
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2020
Actual date on which the first participant was enrolled.Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh
Official TitleEvaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
Principal SponsorCairo University
Study ContactKhalid Amr, PhD
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesFacial InjuriesCraniocerebral TraumaMaxillofacial InjuriesNervous System DiseasesOrbital DiseasesOrbital FracturesSkull FracturesWounds and InjuriesEnophthalmosTrauma, Nervous SystemFractures, Bone
Criteria
5 inclusion criteria required to participate
Adult patients (≤17 years old).
Blow-out Orbital Fracture.
Unilateral Orbital Trauma.
Enophthalmos (≤ 2 mm).
Show More Criteria
5 exclusion criteria prevent from participating
Young Patients (> 17 years old).
Patients with Systemic diseases.
Bilateral Orbital Trauma.
Enophthalmos (>2 mm).
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Orbital fractures
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Faculty of Dentistry - Cairo University
Cairo, EgyptOpen Faculty of Dentistry - Cairo University in Google MapsSuspendedOne Study Center