Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation
Institut Straumann AG
75 participants
Jan 22, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patients of either sex, ≥ 18 years old.
- Partially edentulous patients requiring at least one dental implant.
- Suitable clinical situation as judged by the investigator (e.g., satisfactory soft and hard tissue conditions and occlusion).
- Ability to understand and sign the informed consent form.
- Willingness and ability to participate in the planned study program.
Exclusion Criteria5
- Fully edentulous patients.
- Patients without at least 3 adjacent teeth for accurate positioning of the digital tray, and another tooth for accuracy check (minimum 30 mm distance from marker position).
- Contraindications for dental implant treatment as per the implant Instructions for Use.
- Contraindications listed in the Instructions for Use of the Straumann Falcon system.
- Pregnant women or women planning pregnancy during study participation.
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Interventions
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).
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07518615