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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Only postoperatively within two weeks after the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Measured by distance eye chart. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic results | Which were judged by means of photographs using the 3-score scale as "good", "satisfactory", and "poor". | 6 months postoperatively. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Tanta University | Tanta | Algharbiah | 31511 | Egypt |
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
The data could be available after publication within 6 months from now.
The data will be held on a private cloud and access will be provided upon request from the corresponding author.
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|
| 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). | 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. | 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. | 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. | 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. | Only postoperatively within two weeks after the operation. |
| ID | Term |
|---|---|
| D009917 | Orbital Fractures |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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