Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884126
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2021-05-06
Brief Title:
Customized Oral and Maxillofacial Reconstruction
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Accuracy Fitness Compatibility and Clinical Outcomes of Customized Implants and Prosthesis in Oral and Maxillofacial Reconstruction
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Regional oral and maxillofacial defects secondary to ablative tissue resection can contribute to severe aesthetic and functional loss which influences patients regular life and may cause psychological problems Microvascular free flaps are considered the gold standard for reconstructing large oral and maxillofacial defects In the past decade with the help of computer-aided design CAD computer-aided manufacturing CAM customized implants and prosthesis CIP have led to a significant improvement of the operative accuracy improve the flap survival rate and enhance the patients quality of life
Concerning the increased overall survival rate of the patients people pay more attention to the quality of life and aesthetic appearance which are influenced by the fitness and compatibility of the CIP However from literature reviews the evaluation was various to be concluded in some certain conditions from pooled studies
Concerning the increased overall survival rate of the patients people pay more attention to the quality of life and aesthetic appearance which are influenced by the fitness and compatibility of the CIP However from literature reviews the evaluation was various to be concluded in some certain conditions from pooled studies
Detailed Description:
The trial will be conducted in compliance with the principles of the Declaration of Helsinki specifying which amendment the principles of GCP and all of the applicable regulatory requirements This protocol and related documents will the for review to the Ethics Committee The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site andor Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study The collection processing and disclosure of personal data such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data Directive 9546EC and Belgian law of December 8 1992 on the Protection of the Privacy in relation to the Processing of Personal Data The extracted data will be encoded the subjects EAD-number will be stored separatelysite file from the research data and replaced with a unique study ID-code to create a new identity for the subject The file containing the patient-specific EAD-numbers will be kept on a secured UZ Leuven servers
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