Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

Official title

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

Overview

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.

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.

Interventions

• 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 Pati
• 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.

Primary outcome measures

• Mean angular deviation (°) between planned and actual implant axis (Z-axis) [Time frame: Day 0 (post-operative)]
• Proportion of patients with ≥1 device-related serious adverse device effect (SADE) [Time frame: Day 0 (perioperative)]

Secondary outcome measures (2)

• Mean horizontal (XY) deviation at the implant apex (mm) [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 1 center

• Verwijscentrum Parodontologie Gent — Ghent

Italy · 1 center

• Studio Dentistico Lorenzi — Segni

Netherlands · 1 center

• Erasmus Medical Center — Rotterdam

Switzerland · 1 center

• University of Basel, UZB — Basel

Identifiers

NCT: NCT07518615 · CR2023_02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗