NCT06383377

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Wishbone SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Bone Regeneration
• Safety Issues

Interventions

Type	Name	Description
DEVICE	Tooth extraction and bone graft procedure	The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery. Tooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with the graft will be covered with a collagen sponge (Geistlich Mucograft® Seal) and sutured (cross suture, Vicryl rapide 4.0). If required, a limited connective tissue graft can be placed in the vestibular region. A CBCT scan will be performed after the bone graft procedure, i.e., after the extraction socket and the biomaterial placement, to measure the initial bone width. The safety of the investigational device will be evaluated.

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-03-31
• Completion: 2030-03-31
• First posted: 2024-04-25
• Last updated: 2024-05-29

Locations

5 sites across 1 country: Belgium