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CompletedNCT07879729Updated Oct 19, 2026

Comparison Study Between Custom Made and Ready Made Titanium Mesh in Orbital Floor Reconstruction

An interventional study of reconstruction of orbital floor with custom made mesh and reconstruction of orbital floor with ready made mesh in Orbital Volume and Orbital Floor Reconstruction, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jan 2024, registered Oct 2026).
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

compare between Custom made titanium mesh and ready-made titanium mesh in reconstruction of orbital floor.

02

Conditions studied

  • Orbital Volume
  • Orbital Floor Reconstruction

Keywords

  • orbital floor reconstruction
  • custom-made mesh
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Alexandria University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with unilateral orbital floor fractures either isolated or combined with other facial fractures that require open reduction and internal fixation.
  • Patients must be presented within 7 to 10 days from trauma.
  • Patients suffering from one or more of the following features: diplopia, restricted eye movement, enophthalmos more than 2 mm and infraorbital anesthesia or paresthesia resulting from fracture.
  • Both sexes are included, with an age range from 20 to 50 years.

Exclusion criteria

Exclusion Criteria:

  • Patient suffering from intra-ocular or global hematoma.
  • Chronic systemic diseases such as uncontrolled diabetes, rheumatoid arthritis, immunocompromised status.
  • Patients suffering from bilateral orbital fractures.
  • Infected fracture site.
  • Non displaced fracture.
  • Comminuted fracture.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    custom made titanium mesh

    Device: reconstruction of orbital floor with custom made mesh

  • Active comparator
    ready made titanium mesh

    Device: reconstruction of orbital floor with ready made mesh

Interventions

  • Devicereconstruction of orbital floor with custom made mesh

    reconstruction of orbital floor with custom made mesh

  • Devicereconstruction of orbital floor with ready made mesh

    reconstruction of orbital floor with ready made mesh

06

What researchers measure

Primary outcomes

  1. orbital volume

    Time frame: 6 months

07

Study locations

1 site
  • faculty of dentistry, Alexandria university
    Alexandria, 21624, Egypt
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07879729
Lead sponsor
Alexandria University
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Jan 1, 2024
Primary completion
Jun 8, 2026
Completion
Aug 18, 2026
Last update
Oct 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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