Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07518615

Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

Led by Institut Straumann AG · Updated on 2026-04-08

75

Participants Needed

4

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of either sex, 18 years or older
  • 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
Not Eligible

You will not qualify if you...

  • Fully edentulous patients
  • Patients without at least 3 adjacent teeth for accurate positioning of the digital tray and another tooth at least 30 mm from the marker position for accuracy check
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Verwijscentrum Parodontologie Gent

Ghent, Belgium, 9000

Actively Recruiting

2

Studio Dentistico Lorenzi

Segni, Italy

Not Yet Recruiting

3

Erasmus Medical Center

Rotterdam, Netherlands, 3015

Not Yet Recruiting

4

University of Basel, UZB

Basel, Switzerland, 4058

Actively Recruiting

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Research Team

I

Institut Straumann AG Clinical Research Department

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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