Straumann Falcon dynamic navigation for guided dental implant placement
Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation
This study will test if the Straumann Falcon navigation system helps dentists place dental implants more safely and more accurately in adults missing some teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Straumann AG Industry-sponsored |
| Locations | 4 sites (Ghent and 3 other locations) |
| Trial ID | NCT07518615 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, multicenter clinical investigation enrolling about 75 partially edentulous adult patients across four European centers. Each participant will receive preoperative digital planning, implant placement using the Straumann Falcon real-time dynamic navigation system, and a postoperative CBCT to measure deviations between planned and actual implant positions. The main outcomes are angular deviation compared to literature-derived benchmarks for freehand placement and safety measured by adverse device effects. All surgeons are experienced with implants but are trained on the Falcon system immediately prior to participation.
Who should consider this trial
Good fit: Adults (≥18 years) with partial tooth loss who need one or more dental implants, have adequate adjacent teeth for digital tray positioning and suitable soft and hard tissues, and can give informed consent are ideal candidates.
Not a fit: Fully edentulous patients, those without the required adjacent teeth for the digital tray or accuracy checks, and patients with contraindications to implant therapy or to the Falcon system are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the Falcon system could improve implant placement accuracy and reduce the risk of placement-related complications and corrective procedures.
How similar studies have performed: Other dynamic navigation systems have shown improved implant placement accuracy compared with freehand techniques in prior studies, and the Falcon device is CE-marked though direct multicenter data versus freehand benchmarks remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Ghent and 3 other locations
- Verwijscentrum Parodontologie Gent — Ghent, Belgium (Recruiting)
- Studio Dentistico Lorenzi — Segni, Italy (Not_yet_recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Not_yet_recruiting)
- University of Basel, UZB — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sebastian Kühl, Professor — University Center for Dental Medicine, University of Basel (UZB)
- Study coordinator: Institut Straumann AG Clinical Research Department
- Email: ClinicalResearch@straumann.com
- Phone: +41 61 965 11 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.