New 3D mesh could improve facial fracture surgery
NCT ID NCT06958510
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new 3D-modified anatomical mesh for repairing complex fractures around the eye and cheekbone. Twenty-four adults with these fractures were randomly assigned to receive either the new mesh or standard metal plates and mesh. The goal was to see if the new design leads to better bone alignment and fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 3D-modified anatomical mesh (device)
- What this could lead to
- If successful, this mesh could offer a better way to repair complex facial fractures, potentially improving healing and reducing complications.
- What could go wrong
- This is a small, early-stage trial with only 24 participants. The results may not apply to all patients, and the new mesh might not outperform standard methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16). 2. Fractures that are indicated for open reduction and internal fixation. 3. Patients suffering from ocular complications: 1. Monocular diplopia. 2. Enophthalmos above 2 mm. 3. Restricted ocular motility. 4. Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus. 5. Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period. Exclusion Criteria: 1. Patients with isolated orbital floor defects and blowout fractures. 2. Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects. 3. Patients with bilateral orbital defects. 4. Patients with Infected wounds in periorbital region. 5. Medically compromised patients rendering them inoperable. 6. Patients with ruptured globe or blindness.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Orbital fracture registry aims to improve eye injury care