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Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .
Patients of both groups will be subjected to:
Virtual planning:
A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.
The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated .
The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery.
Intervention Group: -
• The STL file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation
- A transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant.
Control Group: -
• The STL file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps.
Follow up:
All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week .
Only one postoperative CT scan will be done after 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orbital floor reconstruction with Patient Specific Zirconia Implant | Experimental | Orbital floor reconstruction with Patient Specific Zirconia Implant will be done |
|
| Orbital floor reconstruction with Patient Specific Titanium Implant | Active Comparator | Orbital floor reconstruction with Patient Specific Titanium Implant will be done. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orbital floor reconstruction with Patient Specific Zirconia Implant | Procedure | Orbital floor reconstruction with Patient Specific Zirconia Implant will be done |
|
| Measure | Description | Time Frame |
|---|---|---|
| Orbital Volume | will be measured with CT scan in mm3 | immediately post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the patient specific implant in the orbital floor reconstruction | will be measured with CT scan with superimposition of the preoperative CT scan and the mirrored image and the post operative CT scan . The difference will be measured by mm | immediately post operative |
| Cost effectiveness |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| OLA A. ELMORSY, PHD | Contact | 00201141234877 | dr.ola.elmorsy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| OLA A. ELMORSY, PHD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 11511 | Egypt |
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A randomized clinical trial.
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| Orbital floor reconstruction with Patient Specific Titanium Implant | Procedure | Orbital floor reconstruction with Patient Specific Titanium Implant will be done |
|
will compare between the prices of the patient specific implants the titanium and the zirconia and financial record will be kept with that in United states dollar . By the end of the study and comparison will be done to check which one was more cost effective |
| through study completion, an average of 1 year |
| Patient satisfaction | will be assessed by a Questionnaire using Visual analogue scale , highest score will be more satisficed .The score is minimum 1 and maximum 10. | through study completion, an average of 1 year |
| 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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