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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.
Full 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:
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96 participants in 2 patient groups
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Central trial contact
Emilie Dory, CEO; Justine Pirson, R&D Manager
Data sourced from clinicaltrials.gov
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