UnknownPhase 2/3

3D Printed Titanium Mesh vs Guided Autogenous Graft

Egypt32 participantsStarted 2021-09-01

Plain-language summary

In this study, the hypothesis states that there is no significant difference between specified populations. In our case, the 3D printed patient-specific titanium mesh is thought to have the same effect and results in comparison with the computer-guided calvarial bone graft technique according to the related studies.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with previous fresh maxillofacial trauma within 14 days affecting zygomatic bones and orbital walls. * Patients with medical history that did not hinder previous reconstruction of orbital floor defect. * Both genders males and females will be included. Exclusion Criteria: * Patients with craniofacial anomalies or syndromes. * Subjected to irradiation in the head and neck area less than 6 months to -1 year before procedure * Pregnant or nursing females. * Psychiatric problems or unrealistic expectations. * Immunosuppressed or immunocompromised patients.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Orbital volume Measuring

Timeframe: Immediately Post Operative

Trial details

NCT IDNCT05550285

SponsorMohammed Ghassan Mohammed Shaalan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

View on ClinicalTrials.gov More Orbital Floor (Blow-Out) Open Fracture trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.