Bologne

Researchers are evaluating the Global D ZygoFixU implant-prosthetic system, which includes zygomatic implants, prosthetic parts, and special instruments. This system is designed similarly to other zygomatic implants currently on the market and is being studied for its performance and safety in the short to medium term. The study is a prospective, multicenter, European clinical investigation involving adults with advanced maxillary bone loss who need implant treatment. The study involves placing the ZygoFixU implants using specific instruments by experienced oral or cranio-maxillofacial surgeons. Patients will receive two or four zygomatic implants as part of their treatment. This clinical investigation is non-comparative and open-label, conducted in multiple sites across France and Italy. The implants are not CE-marked and are being assessed under class IIb medical device regulations. Participants will be followed for at least one year after surgery to measure the survival rate of the implants. During the study, patients will complete quality-of-life questionnaires and provide follow-up data. Researchers will monitor the implant performance, safety, and patient outcomes over time to establish device conformity and effectiveness at one year postoperatively.