Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation

What this Trial Is About

Researchers are evaluating the Straumann4 Dynamic Navigation System (Falcon) in a prospective, multicenter, multinational clinical investigation to assess its safety and precision for dental implant placement. The study focuses on partially edentulous adult patients who need dental implants. The goal is to compare Falcon's implant positioning accuracy with results reported in literature for freehand implant placement, providing data for regulatory approval and safe clinical use. Participants will all receive dental implant surgery guided by the Falcon dynamic navigation system, which offers real-time visual and interactive guidance using optical tracking and software. Each patient will have one to three implants placed with the system. After surgery, a cone beam computed tomography (CBCT) scan will be performed to measure how closely the implants match the planned positions. The study includes a single treatment group and compares outcomes to literature benchmarks for freehand placement. During the study, patients will undergo preoperative planning and post-operative CBCT imaging to evaluate implant placement accuracy, focusing on angular deviation and spatial positioning. Researchers will monitor safety by tracking any device-related serious adverse effects. The study will last about 12 months from first enrollment to last patient completion, with assessments of procedure time, surgeon satisfaction, and detailed positional accuracy to support regulatory clearance and clinical adoption of the Falcon system.

Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon