Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04895319
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2021-05-17
Brief Title:
Adherence to Computer-assisted Maxillofacial Reconstructions
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
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:
None
Brief Summary:
The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020 Reconstruction with computer-assisted surgery CAS which included virtual surgical planning computer-aided design-computer-aided manufacturing CAD-CAM surgical guidestemplates and pre-bent plates on 3D printed models Reasons for tissue defect were oncologic osteoradionecrosis trauma and osteoporosis Patients undergoing dental implant placement and orthognathic surgery were excluded Finally 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed
Detailed Description:
computer-aided design
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