Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Mean angular deviation (°) between planned and actual implant axis (Z-axis) — 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°.
• Proportion of patients with ≥1 device-related serious adverse device effect (SADE) — 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.

Trial sites (4)

Other trials for the same condition