Prospective Multicenter European Study Evaluating Performance and Safety of the Global D ZygoFixU Implant-prosthetic System

What this Trial Is About

Researchers are evaluating the Global D ZygoFixU implant-prosthetic system designed for adult patients with severe maxillary bone loss who need dental implants. This study is a European multicenter, prospective, open-label clinical investigation focused on assessing the device's performance and safety over the short and medium term. The trial includes adult men and women whose maxillary bone growth is complete and who are partially or fully missing teeth with advanced atrophy. The study involves placing two or four zygomatic implants using the ZygoFixU system by experienced oral or cranio-maxillofacial surgeons trained in clinical research. These implants and associated instruments are non-CE marked but share design features with other available implants. The main goal is to measure the implant survival rate at one year after surgery, with additional follow-up to evaluate safety, success rates, patient quality of life, and satisfaction over five years. Participants will be closely monitored through scheduled follow-up visits for up to five years to assess implant survival and safety, record any device-related complications, and evaluate both patient and surgeon satisfaction. They will complete quality-of-life questionnaires before surgery and at multiple points afterward, including 6-8 months, 1 year, and annually up to 5 years. The study ensures careful data collection and ongoing assessment to understand the device's medium and long-term performance.

Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System