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Clinical Trial 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.


Clinical Trial Description

In this study, the subjects will be pseudonymized and randomized in a 1:1 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 2017/745. 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 Design


Related Conditions & MeSH terms


NCT number NCT06383377
Study type Interventional
Source Wishbone SA
Contact Emilie Dory, CEO
Phone +32484706172
Email emilie.dory@wishbone-biotech.com
Status Recruiting
Phase N/A
Start date April 26, 2024
Completion date March 31, 2030

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