Comparing zirconia and titanium implants for orbital floor reconstruction
Assessment of Accuracy and Orbital Volume Using Patient Specific Titanium Implant Vs Patient Specific Zirconia Implant for Orbital Floor Reconstruction in Blowout Fractures A Randomized Clinical Trial: Comparative Study
NA · Cairo University · NCT06369129
This study is testing whether custom zirconia implants work better than titanium implants for repairing the eye socket after a fracture.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06369129 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of patient-specific zirconia implants versus titanium implants in reconstructing the orbital floor after blow-out fractures. Patients will undergo a thorough evaluation, including medical history, cranial and maxillofacial examination, visual function assessment, and CT scans. The surgical procedure will involve creating a virtual plan for implant design, followed by surgery under general anesthesia within 14 days of injury. The goal is to determine which implant offers better accuracy, adaptability, and cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with isolated or combined blow-out fractures who are medically fit for surgery.
Not a fit: Patients with previous orbital reconstruction surgery or those who are medically compromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with orbital fractures.
How similar studies have performed: While there have been studies on titanium implants, the use of zirconia in this specific context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with blow out fracture isolated and / or combined with other fracture. * Age group: from 18 to 60 years old * No sex predilection * Patients with no contraindications to surgical intervention. * Patients willing for the surgical procedure and follow-up, with an informed consent. Exclusion Criteria : * Medically compromised patients. * Patients with history of previous orbital reconstruction surgery. * Uncooperative patients. * Patients with systemic contraindication to general anesthesia.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: OLA A. ELMORSY, PHD — Cairo University
- Study coordinator: OLA A. ELMORSY, PHD
- Email: dr.ola.elmorsy@gmail.com
- Phone: 00201141234877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blow-Out Fractures, Orbital Fractures, Orbital Floor Fracture, Orbital Trauma