Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Falcon
1 other identifier
interventional
75
4 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2026
CompletedFirst Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 8, 2026
April 1, 2026
1.2 years
February 25, 2026
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean angular deviation (°) between planned and actual implant axis (Z-axis)
Measurement of the absolute angular difference between the planned and achieved implant axis around the Z-axis, quantified via superimposition of pre-operative planning and post-operative CBCT. The primary objective is to demonstrate non-inferiority compared to a performance goal of 5.5°.
Day 0 (post-operative)
Proportion of patients with ≥1 device-related serious adverse device effect (SADE)
Percentage of participants experiencing at least one serious adverse device effect (SADE) as defined by ISO 14155. This includes any serious adverse event related to the use of the dynamic navigation system or the surgical procedure.
Day 0 (perioperative)
Secondary Outcomes (2)
Mean horizontal (XY) deviation at the implant apex (mm)
Day 0 (immediately after the post-operative CBCT)
Mean horizontal (XY) deviation at the implant shoulder (mm)
Day 0 (immediately after the post-operative CBCT)
Study Arms (1)
Falcon Dynamic Navigation System
EXPERIMENTALAll participants will undergo dental implant placement using the Straumann Falcon Dynamic Navigation System. The system provides real-time, computer-assisted surgical navigation to guide implant positioning. Postoperative cone beam computed tomography (CBCT) imaging will be performed to assess accuracy by comparing planned versus actual implant position. Outcomes will be compared against performance goals derived from literature on freehand implant placement.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Verwijscentrum Parodontologie Gent
Ghent, 9000, Belgium
Studio Dentistico Lorenzi
Segni, Italy
Erasmus Medical Center
Rotterdam, 3015, Netherlands
University of Basel, UZB
Basel, 4058, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Kühl, Professor
University Center for Dental Medicine, University of Basel (UZB)
Central Study Contacts
Institut Straumann AG Clinical Research Department
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
April 8, 2026
Study Start
January 22, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared because of patient confidentiality concerns and company policy for industry-sponsored device trials. Only aggregate summary results will be made available through ClinicalTrials.gov and scientific publications.