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RecruitingNCT07791095Updated Aug 27, 2026

REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES

A Phase 4 interventional study of pre-adapted titanium miniplates based on a virtually reduced 3D model in Naso-Orbito-Ethmoidal, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Alexandria University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to assess the reduction accuracy of Naso-orbito-ethmoidal (NOE) fractures using pre-adapted titanium miniplates based on a virtually reduced 3D model.

02

Conditions studied

  • Naso-Orbito-Ethmoidal

Keywords

  • Virtual reduction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Active Infection or Heavily Contaminated Open Fractures.
  • Old Fractures.
  • Patients unsuitable or unable to tolerate surgery.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Patients with Naso-orbito-ethmoidal (NOE) fractures

    Device: pre-adapted titanium miniplates based on a virtually reduced 3D model

Interventions

  • Devicepre-adapted titanium miniplates based on a virtually reduced 3D model

    Naso-orbito-ethmoidal (NOE) treated using pre-adapted titanium miniplates based on a virtually reduced 3D model

05

What researchers measure

Primary outcomes

  1. Intercanthal distance

    Intercanthal distance is measured by seating the patient upright with the head in neutral position and eyes in primary gaze, then placing a rigid ruler horizontally across the nasal bridge to measure the linear distance between the medial canthi, recording the value in millimeters.

    Time frame: Immediately after the surgery

  2. Reduction accuracy

    To evaluate the success of fracture reduction and fixation, a baseline CT scan will be acquired for each patient It will then be superimposed on the virtual plan model using MIMICS software.

    Time frame: Immediately after the surgery

06

Study locations

1 of 1 sites recruiting
  • Faculty of dentistry, Alexandria university
    Alexandria, 21523, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07791095
Lead sponsor
Alexandria University
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Nov 1, 2025
Primary completion
Sep 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

Rim Ismail, M.D
Contact
Reem.ismail.dent@alexu.edu.eg
01501987877

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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