Zygomaticomaxillary Complex FractureNCT07103187
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
A study testing Zygomatico-Orbital reconstruction in people with Zygomaticomaxillary Complex Fracture and Orbital Floor Fractures, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Zygomaticomaxillary Complex Fracture, Orbital Floor Fractures, Ophthalmic Trauma
- What is being tested?
- Zygomatico-Orbital reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Bilateral zygomatico-orbital fractures.
- Rupture of the globe.
- Hyphema.
- Retinal detachment.
- Traumatic optic nerve lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Prebent Titanium Mesh With 3D-Printed Model in Reconstruction of Zygomatico-Orbital Fractures
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.
Read the detailed description
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.
- Being tested
- Zygomatico-Orbital reconstruction
- Keywords
- Orbital reconstruction, Orbital fractures, Automatic segmentation, 3D orbital analysis, Orbital volume, Orbito-zygomatico-maxillary complex fracture
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zygomatico-Orbital reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Only single arm of the study | Experimental | This is the only arm of the study containing 12 patients who will be operated for reconstruction for unilateral OZMC fracture. A lot of outcome measures will be measured to evaluate the effectiveness of the intervention. Receives: Procedure: Zygomatico-Orbital reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbital volume
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.
Measured: Preoperatively. Postoperatively within two weeks after the operation.
Area of bone defect (Orbital symmetry)
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.
Measured: Preoperatively. Postoperatively within two weeks after the operation.
Acuraccy of Orbito-Zygomatico-maxillary complex fracture reconstruction
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.
Measured: Only postoperatively within two weeks after the operation.
Secondary outcomes (7)
Visual acuity
Measured by distance eye chart.
Measured: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Vertical dystopia
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.
Measured: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Enophthalmos
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).
Measured: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Diplopia
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.
Measured: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Ocular motility
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.
Measured: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
The layout angle
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.
Measured: Only postoperatively within two weeks after the operation.
The gap length
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.
Measured: Only postoperatively within two weeks after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jun 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomaticomaxillary Complex FractureStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYMAN M. ARAKEEP, MSc, PhD researcher, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103187
- Sponsor's protocol ID
- R-OS-1-19-8
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient data without any identity show could be available by request from the corresponding author including clinical photos and raw tables for all data entry of the study
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Prebent Titanium Mesh With 3D-Printed Model in Reconstruction of Zygomatico-Orbital Fractures
- ClinicalTrials.gov ID
- NCT07103187
- Acronym / sponsor ID
- R-OS-1-19-8
- Keywords
- Orbital reconstruction, Orbital fractures, Automatic segmentation, 3D orbital analysis, Orbital volume, Orbito-zygomatico-maxillary complex fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only single arm of the study | Experimental | Procedure: Zygomatico-Orbital reconstructionThis is the only arm of the study containing 12 patients who will be operated for reconstruction for unilateral OZMC fracture. A lot of outcome measures will be measured to evaluate the effectiveness of the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Bilateral zygomatico-orbital fractures.
- Rupture of the globe.
- Hyphema.
- Retinal detachment.
- Traumatic optic nerve lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zygomatico-Orbital reconstructionZygomatico-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. | Procedure or surgery | Only single arm of the study |
Primary outcome
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.
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.
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.
7 secondary outcomes
Visual acuity
Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Vertical dystopia
Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Enophthalmos
Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Diplopia
Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
Ocular motility
Time frame: Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.
The layout angle
Time frame: Only postoperatively within two weeks after the operation.
The gap length
Time frame: Only postoperatively within two weeks after the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. All patient data without any identity show could be available by request from the corresponding author including clinical photos and raw tables for all data entry of the study
Related trials for Zygomaticomaxillary Complex Fracture
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
Not yet recruiting
Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction
Facial Bone Fracture, Maxillofacial Injury
Recruiting
BoneTape Feasibility Trial
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zygomatico-Orbital reconstruction in people with Zygomaticomaxillary Complex Fracture and Orbital Floor Fractures, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbital volume (time frame: Preoperatively. Postoperatively within two weeks after the operation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.