An interventional study of Post-operative Cone Beam Computed Tomography (CBCT) and Straumann Falcon Dynamic Navigation System in Partially Edentulous Jaw, Tooth Loss and Dental Implant, sponsored by Institut Straumann AG. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Institut Straumann AG · Not applicable, Interventional, and Treatment
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.
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.
76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.
This study's planned enrollment of 75 is above the median of 38 across 67 interventional studies indexed under Jaw, Edentulous, Partially.
Browse Jaw, Edentulous, Partially studies →Institut Straumann AG is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All 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.
Diagnostic Test: Post-operative Cone Beam Computed Tomography (CBCT) · Device: Straumann Falcon Dynamic Navigation System · Device: Dental Implants
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).
Also known as: Post-operative CBCT imaging
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.
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°.
Time frame: 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.
Time frame: Day 0 (perioperative)
Mean horizontal (XY) deviation at the implant apex (mm)
Absolute 2D horizontal deviation (mesiodistal and bucco-oral) between planned and actual implant position at the apex, quantified on post-operative CBCT. Lower values indicate greater accuracy. Evaluated against literature-based freehand performance goals (2.0 mm, NI-limit 2.2 mm).
Time frame: Day 0 (immediately after the post-operative CBCT)
Mean horizontal (XY) deviation at the implant shoulder (mm)
Absolute 2D horizontal deviation (mesiodistal and bucco-oral) between planned and actual implant position at the shoulder (base), quantified on post-operative CBCT.. Lower values indicate greater accuracy. Evaluated against literature-based freehand performance goals (1.2 mm, NI-limit 1.3 mm).
Time frame: Day 0 (immediately after the post-operative CBCT)
Plan to share: No — 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.
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