Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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
• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Mean horizontal (XY) deviation at the implant apex (mm) [Срок оценки: Day 0 (immediately after the post-operative CBCT)]
• Mean horizontal (XY) deviation at the implant shoulder (mm) [Срок оценки: Day 0 (immediately after the post-operative CBCT)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Verwijscentrum Parodontologie Gent — Ghent

Италия · 1 центр

• Studio Dentistico Lorenzi — Segni

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Швейцария · 1 центр

• University of Basel, UZB — Basel

Идентификаторы

NCT: NCT07518615 · CR2023_02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗