Dental implant-supported reconstructions are a well-established treatment modality. Accurate implant positioning is essential for long-term functional and esthetic success. Freehand implant placement remains widely used but is subject to variability depending on surgeon experience. Dynamic navigation technology offers real-time guidance during surgery, with the potential to improve accuracy and reduce complications.
The Straumann® Falcon Dynamic Navigation System is CE-marked and indicated for locating and displaying the position of dental instruments in the oral cavity. Falcon integrates a stereoscopic optical camera, reference marker, 3D-printed digital trays, and real-time software guidance. Surgeons are visually and interactively guided on a touchscreen monitor to achieve precise implant placement.
This clinical investigation (CR_2023_02) is a prospective, single-arm, post-market, multinational study conducted in accordance with ISO 14155:2020, EU MDR, ICH-GCP, and the Declaration of Helsinki. Approximately 75 partially edentulous patients will be enrolled at four European sites. All investigators are experienced implant surgeons but naïve to Falcon prior to training. Each patient will receive 1-3 implants placed with Falcon, followed by a postoperative CBCT scan to assess deviations between planned and actual implant position.
The primary effectiveness objective is to demonstrate non-inferiority of Falcon versus literature-derived freehand performance goals in angular deviation (Z-axis). The primary safety objective is to show that the proportion of patients with device-related serious adverse device effects (SADEs) is less than 6%. Secondary endpoints include deviations at implant apex and shoulder (XY), 3D positional accuracy, procedure duration, and surgeon satisfaction.
Safety oversight will be provided by a sponsor-appointed Safety Monitoring Board. The study duration is approximately 12 months (from first patient enrolled to last patient out). Outcomes will support FDA clearance and broader clinical adoption of Falcon for dental implant surgery.
