Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383377
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-10
Brief Title:
Evaluation of Performance Safety and Benefit of the Wishbone HA as Bone Graft Substitute a Pre-market Clinical Investigation
Sponsor:
Wishbone SA
Organization:
Wishbone SA
Study Overview
Official Title:
Prospective Multi-center Randomized Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance Safety and Benefit of the Wishbone HA Medical Device a Deproteinized Bovine Bone Material as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This investigation is a pre-market prospective multi-center randomized single blinded parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket
Detailed Description:
In this study the subjects will be pseudonymized and randomized in a 11 ratio between WHA and the selected comparator device Bio-Oss The sample size of the study has been computed based on a non-inferiority test between Bio- Oss and WHA for device performance for the filling of extraction sockets A total of 96 subjects will be enrolled
The results will be used to demonstrate the safety performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017745
The endpoints are all accurately based on objective measurements
Primary Endpoint Bone reconstruction as measured by CBCT in mm after bone grafting procedure
Secondary Endpoints
Evaluation of implant stability at placement
Assessment of bone density at the time of implant insertion
Implant osteointegration at 3months after implant placement
Evaluation of implant survival and success at 3- 6-and12-months 3-and 5- years after implant placement
Rate of all Adverse Device Events incidence type relatedness severity seriousness from the time of grafting procedure up to 5 years after implant placement
Patient satisfaction 6- and 12-months after implant placement
Evaluation of the Sulcus index peri-implant marginal tissue health status at 6- and 12-months after implant placement
The results will be used to demonstrate the safety performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017745
The endpoints are all accurately based on objective measurements
Primary Endpoint Bone reconstruction as measured by CBCT in mm after bone grafting procedure
Secondary Endpoints
Evaluation of implant stability at placement
Assessment of bone density at the time of implant insertion
Implant osteointegration at 3months after implant placement
Evaluation of implant survival and success at 3- 6-and12-months 3-and 5- years after implant placement
Rate of all Adverse Device Events incidence type relatedness severity seriousness from the time of grafting procedure up to 5 years after implant placement
Patient satisfaction 6- and 12-months after implant placement
Evaluation of the Sulcus index peri-implant marginal tissue health status at 6- and 12-months after implant placement
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