Clinical Safety and Efficacy of the Straumann Dynamic Navigation System (Straumann® Falcon System): A Prospective Multicenter and Multinational Clinical Study

Résumé de l'étude

Dental implants are typically used to replace missing teeth and restore both function and appearance. For the treatment to be successful, the implant must be placed accurately. Traditionally, implants are placed using the freehand method, which depends on the skills and experience of the dentist. With advancements in technology, computer-assisted dynamic navigation has emerged as an alternative to the freehand method. This technology helps the dentist visualize important structures in your mouth and provides real-time guidance on the position, angle, and depth of dental instruments, improving the precision and control of the instruments. The Straumann® Falcon System utilizes this dynamic navigation technology to guide the dentist during the procedure by displaying the exact position of the dental instrument on a computer screen. As this technology continues to evolve, the safety and accuracy of the Straumann® Falcon System must be continuously investigated to assess its efficacy in placing dental implants. The primary purpose of this study is to evaluate the efficacy and safety of the Straumann® Falcon System when used by dentists who are new to this technology. During your participation, you will visit us for study visits two to three times. All of these appointments are part of your overall treatment and will also be conducted independently of your study participation. On the day of the operation, we will take an additional X-ray, which will extend the duration of the operation by approximately 30 minutes, and you will be exposed to slightly increased radiation.

(BASEC)

Intervention étudiée

The study investigates the digital navigation system called Straumann® Falcon, which is already approved in Switzerland and aims to assist dentists in the precise placement of dental implants. This system helps track the position and depth of the implant in real-time during the surgery to improve the accuracy of implant placement. The main purpose of this study is to evaluate the efficacy and safety of the Straumann® Falcon System when used by dentists who are new to this technology. All study dentists will receive standardized training to familiarize themselves with the Falcon system.

(BASEC)

Maladie en cours d'investigation

General Information about the Study The study investigates a novel digital navigation system called Straumann® Falcon, which aims to assist dentists in the precise placement of dental implants. This system helps track the position and depth of the implant in real-time during the surgery to improve the accuracy of implant placement. The study is funded by the company Institut Straumann AG from Basel. A total of four European sites from Switzerland, Italy, the Netherlands, and Belgium will participate. The study is expected to begin in the third quarter of 2025 and last for one year. Study Objective The main objective is to investigate whether implant placement with the Straumann® Falcon is more accurate and safer than the traditional hand method. It primarily focuses on the deviation between the planned and the actual achieved angle and position of the implant. It will also examine how well dentists who have no prior experience with the system cope with it. Additionally, it will be checked whether the use of the system leads to fewer complications, particularly serious adverse events (SADE). Study Design and Procedure The study is a prospective, multicenter clinical investigation. This means that patients are specifically selected for the study, and data from multiple clinics are evaluated together. 75 patients requiring planned implantation are to participate. Each of them will receive one to three implants. There are three doctor visits: one for information, one for enrollment in the study, and one for the implantation procedure with subsequent control. The treatment will be conducted with already approved products.

(BASEC)

Sponsor

Institut Straumann AG

(BASEC)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Date d'approbation du comité d'éthique

08.10.2025

(BASEC)

Résultats de l'essai