Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05438784
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2022-06-21
Brief Title:
Application of CAD-CAM Technology in Orbital Bone Reconstruction
Sponsor:
Hatem Adel Aboelhassan
Organization:
Sohag University
Study Overview
Official Title:
Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology A Clinical Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAD-CAM
Brief Summary:
Reconstruction of orbital defects resulting after trauma tumor resection maxillary cyst craniofacial anomalies and sequestrated bone etc has been a challenging issue over the years and this owing to the complicated anatomy of orbit Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications Titanium mesh for orbital reconstruction has now become probably the most popular material for orbital wall reconstruction worldwide Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology
Detailed Description:
This study will be a prospective cohort study It will include patients treated with the custom-made implants for orbital blow out fractures ZMC fractures or tumors The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial Head and Neck Unit General Surgery Department Faculty Of Medicine Sohag University Egypt The patients will be randomly divided into two groups group A reconstructed with patient specific implant and group B reconstructed with preformed plate preoperatively bended on stereolithographic model The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data All patients will be assessed clinically ophthalmologically and radiographically using computed tomography CT then virtual surgical planning and custom-made patient implant will be manufactured Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure comparing data of the two groups will be done using appropriate methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None