Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Straumann AG
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Post-operative Cone Beam Computed Tomography (CBCT)
- Straumann Falcon Dynamic Navigation System
- Dental Implants
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov