Study to Compare Wishbone HA and Bio-Oss Bone Graft Materials for Tooth Extraction Socket Preservation Before Implant Placement

What this Trial Is About

Researchers are evaluating the use of Wishbone HA WHA, a bone graft substitute, for filling extraction sockets to support bone preservation before implant placement. This prospective, randomized, single-blinded clinical investigation involves at least five centers and compares WHA to an established product called Bio-Oss. The study aims to confirm the safety, performance, and benefits of WHA in this bone regeneration context, following regulatory requirements. Participants will have a tooth extracted in a minimally traumatic way, and the socket will be filled with either WHA or Bio-Oss granules. Follow-up visits will occur at 2 and 6 weeks to monitor healing. Implant placement is planned four months after grafting, with implant loading after a minimum of three months post-placement. Implant survival and success will be assessed up to five years after placement, including long-term follow-up visits. Throughout the study, participants will undergo CBCT imaging to measure bone reconstruction, assessments of implant stability and bone density, and evaluations of implant integration and survival. Patient satisfaction and tissue health around the implant will also be monitored up to a year or more after implant placement. Safety will be tracked by recording any device-related adverse events for up to five years, ensuring comprehensive monitoring during the study period.

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