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Completed

NCT Number: NCT07103187

Evaluating The Prebent Titanium Mesh for Zygomatico-Orbital Reconstruction in Twelve Patients Measuring Multiple Ophthalmologic Parameters, Aesthetic Results, Orbital Volume, Area of Bone Defect, Layout Angle, Gab Length and The Accuracy of Reconstruction

Purpose: The aim of this study was to evaluate the role of using a prebent titanium mesh on a 3D-printed model as an intraoperative guide to reconstruct orbito-zygomatic-maxillary complex (OZMC) fractures.

Subjects and method: This is a prospective, interventional, longitudinal, single armed case series study that was carried out on twelve patients with unilateral displaced orbito-zygomatico-maxillary complex (OZMC) fracture indicated for orbital floor reconstruction as evidenced by clinical and radiographic examination. Open reduction and internal fixation were utilized to treat those fractures, patients were collected from the department of Oral and Maxillofacial surgery, Faculty of Dentistry, Tanta University. Post-operative evaluation: all patients underwent regular follow up for six months. The following parameters were evaluated: visual acuity, external appearance of the eye including hypoglobus and enophthalmos, diplopia, ocular motility, the aesthetic results, orbital volume, area of bone defect, layout angle, gab length and the zygomatic reconstruction.

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Key information

Conditions

Zygomaticomaxillary Complex Fracture Craniocerebral Trauma Facial Injuries Fractures, Bone Maxillofacial Injuries Nervous System Diseases Ophthalmic Trauma Orbital Floor Fractures Orbital Fractures Skull Fractures Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, Algharbiah, 31511, Egypt

About this study

This study was conducted on twelve patients with unilateral displaced OZMC fracture indicated for orbital floor reconstruction as evidenced by clinical and radiographic examination. The patients' ages ranged from 18-55 years old. All patients were evaluated preoperatively for collecting demographic data, taking general medical, surgical, and dental history and for determining the main patient's chief complaints and postoperative expectations. Approval for this project was obtained from Research Ethics Committee (REC) of faculty of Dentistry, Tanta University. The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines of human research adopted by the REC at Faculty of Dentistry, Tanta University. After obtaining the preoperative CT scan, 3D simulation was performed using (3Diagnosys, version 4.2, 3diemme. Como, Italy) as the following steps:

  • Importing CT DICOM images.
  • Mirror image of the normal side.
  • Segmentation to remove any unwanted areas.
  • Thresholding to choose the density of bone.
  • Conversion to STL format.
  • Exporting as an STL file to the 3D printer. The 3D printer (Upbox, Tiertime, Korea) was used to print the patient specific model. The Printing material was ABS/PLA. The technology used for the printing process was FDM (Fused Deposition Modeling), where a filament is heated above 200 degrees and extruded through a nozzle of 0.4 mm diameter to print layer by layer with a resolution of 100 microns. Routine preoperative investigations (complete blood picture, prothrombin test, liver &renal function test and viral profile) were done for all patients, together with relevant medical consultation when required. The patients were operated under general anesthesia via nasal endotracheal intubation. The surgical site was disinfected using Povidone-iodine then isolated and draped with sterile dressing. Reconstruction was done carefully. All outcome measures were measured later on, and adequate statistical analysis was performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unilateral displaced zygomatico-orbital fracture (with fractured orbital floor).
  • Patients with no previous history of orbital reconstruction.
  • Diplopia within 30° of primary gaze.
  • Radiological evidence of extraocular muscle entrapment and/or positive forced duction test.
  • Enophthalmos of more than 2mm.

Exclusion criteria

  • Bilateral zygomatico-orbital fractures.
  • Rupture of the globe.
  • Hyphema.
  • Retinal detachment.
  • Traumatic optic nerve lesions.

Treatment and study plan

Zygomatico-Orbital reconstruction

Procedure

Zygomatico-Orbital reconstruction was done by ORIF for the zygomatic complex fractures at multiple suture lines by mini plates and screws. Orbital floor reconstruction was done mainly by using a prebent titanium mesh on a 3D printed model.

Primary outcomes

  1. Orbital volume

    Time frame: Preoperatively. Postoperatively within two weeks after the operation.

    By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.

  2. Area of bone defect (Orbital symmetry)

    Time frame: Preoperatively. Postoperatively within two weeks after the operation.

    By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.

  3. Acuraccy of Orbito-Zygomatico-maxillary complex fracture reconstruction

    Time frame: Only postoperatively within two weeks after the operation.

    On a postoperative CT scan of the face adequate zygomatic reduction was judged by evaluating any involved parts from the following reference points, including zygomaticofrontal suture, zygomatico-sphenoidal suture, zygomaticomaxillary buttress, inferior orbital rim, and zygomatic arch, which was judged by two experienced surgeons as good, satisfactory or poor.

Secondary outcomes

  1. Visual acuity

    Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

    Measured by distance eye chart.

  2. Vertical dystopia

    Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

    Measured by drawing an imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is in the lower level in relation to the intact eye which revealed hypoglobus.

  3. Enophthalmos

    Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

    Measured by the aid of exophthalmometer represented by four grades from 0 to 3 as follows: grade 0 = no enophthalmos, grade 1= mild enophthalmos (less than 1 mm), grade 2= moderate enophthalmos (ranged from 1 to 2 mm), grade 3= severe enophthalmos (over 2mm).

  4. Diplopia

    Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

    Assessed if it was present in the primary position of gaze, within 30° degree or in a secondary position of gaze depending on the patient response by specialized ophthalmologist.

  5. Ocular motility

    Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

    Tested by asking the patient to follow a moving target into the diagnostic positions of gaze observing the extent of movement of each eye. The amount of limitation of movement is classified as grade 1= slight limitation, grade 2= moderate limitation, grade 3= marked limitation or grade 4= no movement according to the observation of two independent examiners.

  6. The layout angle

    Time frame: Only postoperatively within two weeks after the operation.

    Measured on a postoperative CT scan of the face and defined as an acute angle between the titanium mesh and an arbitrary line representing the premorbid status of the orbital floor connecting the starting point of the orbital floor fracture to its end. This line reflects the normal bone contour and is easy to suppose from contralateral normal orbital floor.

  7. The gap length

    Time frame: Only postoperatively within two weeks after the operation.

    Measured on a postoperative CT scan of the face and defined as the distance from the distal tip of the titanium mesh to the posterior bone shelf margin.

Other outcomes

  1. Aesthetic results

    Time frame: 6 months postoperatively.

    Which were judged by means of photographs using the 3-score scale as "good", "satisfactory", and "poor".

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Role of Prebent Titanium Mesh With 3D-Printed Model in Reconstruction of Zygomatico-Orbital Fractures

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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