Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon (Falcon)

April 2, 2026 updated by: Institut Straumann AG

Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Falcon Dynamic Navigation System
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)
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).
Other Names:
  • Post-operative CBCT imaging
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean angular deviation (°) between planned and actual implant axis (Z-axis)
Time Frame: Day 0 (post-operative)
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)
Time Frame: Day 0 (perioperative)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean horizontal (XY) deviation at the implant apex (mm)
Time Frame: Day 0 (immediately after the post-operative CBCT)
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).
Day 0 (immediately after the post-operative CBCT)
Mean horizontal (XY) deviation at the implant shoulder (mm)
Time Frame: Day 0 (immediately after the post-operative CBCT)
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).
Day 0 (immediately after the post-operative CBCT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Straumann AG

Investigators

  • Principal Investigator: Sebastian Kühl, Professor, University Center for Dental Medicine, University of Basel (UZB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR2023_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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