Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Safety Issues Clinical Trial

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

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

Clinical Trial Details

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

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.