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Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Sponsor: Institut Straumann AG
Summary
The Falcon Study is a prospective, multicenter, multinational clinical investigation evaluating the Straumann® Dynamic Navigation System (Falcon) for dental implant placement. The Falcon system is a real-time dynamic navigation device that helps clinicians visualize the position of dental instruments during surgery. The purpose of the study is to assess whether Falcon enables safe and precise implant placement in partially edentulous patients compared to benchmarks from the literature for freehand implant placement. The study will enroll approximately 75 adult patients across four European centers (Switzerland, Italy, the Netherlands, and Belgium). Each patient will undergo preoperative planning, implant surgery with the Falcon system, and a postoperative cone beam computed tomography (CBCT) scan to measure implant placement accuracy. The main outcomes are (1) angular deviation between planned and actual implant position, and (2) safety as measured by adverse device effects. Results will provide clinical evidence to support regulatory clearance and the safe adoption of the Falcon system in routine practice.
Official title: Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-01-22
Completion Date
2027-04
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
Post-operative Cone Beam Computed Tomography (CBCT)
All patients will undergo a post-operative CBCT scan following dental implant placement with the Straumann Falcon system. The scan is study-specific and not part of routine treatment. It enables quantitative comparison of planned versus achieved implant position to assess accuracy outcomes. Radiation exposure will be minimized by using small field of view (FOV) low-dose CBCT protocols in accordance with the ALADAIP principle (As Low As Diagnostically Acceptable being Indication-oriented and Patient-specific).
Straumann Falcon Dynamic Navigation System
A computer-assisted navigation system used to provide real-time guidance during the surgical placement of dental implants. The system uses optical tracking and proprietary software to align the pre-operative virtual plan with the patient's anatomy during surgery.
Dental Implants
Surgical placement of Straumann dental implants as specified in the study protocol. The implants are placed using the dynamic navigation system to achieve the planned position.
Locations (4)
Verwijscentrum Parodontologie Gent
Ghent, Belgium
Studio Dentistico Lorenzi
Segni, Italy
Erasmus Medical Center
Rotterdam, Netherlands
University of Basel, UZB
Basel, Switzerland