Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

ConditionsPartially Edentulous Jaw Tooth Loss Dental Implant

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorInstitut Straumann AG

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Post-operative Cone Beam Computed Tomography (CBCT)
Diagnostic test
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
Device
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
Device
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.

Treatment groups

75 Participants

are divided into 1 treatment group

Group A: Falcon Dynamic Navigation SystemExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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)

Secondary outcomes

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)