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Can 3D-Printed plates make facial fracture surgery more precise?

NCT ID NCT07791095

Disease control Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether using titanium miniplates shaped from a virtual 3D model improves the accuracy of surgery for naso-orbito-ethmoidal (NOE) fractures, a type of complex facial injury. Researchers will compare the surgical result against the planned virtual model using CT scans. The study includes 15 adults with acute NOE fractures who need surgery. The goal is to see if this pre-adaptation technique leads to better bone alignment and facial symmetry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pre-adapted titanium miniplates based on a virtually reduced 3D model
What this could lead to
If successful, this approach could make surgery for complex facial fractures more precise, potentially improving cosmetic and functional outcomes.
What could go wrong
This is a small trial with only 15 participants, so results may not apply broadly. The procedure requires advanced imaging and planning, and there is a risk of infection or implant issues.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * CT-confirmed naso-orbito-ethmoidal (NOE) fracture (unilateral or bilateral) requiring operative fixation (ORIF). * Acute fractures with injury-to-definitive surgery ≤ 14 days. * Skeletally mature patients (above 18 years). * Medically fit for general anesthesia and craniofacial surgery (ASA1). * Ability to attend for follow-up. Exclusion Criteria: * Active Infection or Heavily Contaminated Open Fractures. * Old Fractures. * Patients unsuitable or unable to tolerate surgery.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Naso-orbito-ethmoidal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Faculty of dentistry, Alexandria university

    RECRUITING

    Alexandria, 21523, Egypt