Partially Edentulous JawFalconNCT07518615
Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
A study testing Post-operative Cone Beam Computed Tomography (CBCT), Straumann Falcon Dynamic Navigation System and Dental Implants in people with Partially Edentulous Jaw and Tooth Loss, run by Institut Straumann AG at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Jaw, Tooth Loss, Dental Implant
- What is being tested?
- Post-operative Cone Beam Computed Tomography (CBCT), Straumann Falcon Dynamic Navigation System and Dental Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 22 Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Institut Straumann AG Clinical Research Department contact
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
Verwijscentrum Parodontologie Gent
Ghent, 9000
Maarten Glibert, +32 9 220 3779, maarten.glibert@ugent.be
Italy1 site, 1 recruiting
- Not yet recruiting
Studio Dentistico Lorenzi
Segni
Claudia Lorenzi, +39 06 976 8360, claudialorenzimartinez@gmail.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus Medical Center
Rotterdam, 3015
Justin Pijpe, +31 641 397 764, j.pijpe@erasmusmc.nl
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel, UZB
Basel, 4058
Sebastian Kühl, Professor, +41 61 267 2525, sebastian.kuehl@unibas.ch
About this study
Official title: Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation
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.
Read the detailed description
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.
- Conditions
- Partially Edentulous Jaw, Tooth Loss, Dental Implant
- Being tested
- Post-operative Cone Beam Computed Tomography (CBCT), Straumann Falcon Dynamic Navigation System, Dental Implants
- Keywords
- Dental Implant, Dynamic Navigation, Computer-Assisted Surgery, Falcon System, Straumann, CBCT (Cone Beam Computed Tomography), Partially Edentulous Patients, Accuracy of Implant Placement, Post-Market Clinical Investigation
- Medical subject headings
- Jaw, Edentulous, Partially, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative Cone Beam Computed Tomography (CBCT)Diagnostic test
Also called Post-operative CBCT imaging
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 SystemDevice
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 ImplantsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Falcon Dynamic Navigation System | Experimental | All participants will undergo dental implant placement using the Straumann Falcon Dynamic Navigation System. The system provides real-time, computer-assisted surgical navigation to guide implant positioning. Postoperative cone beam computed tomography (CBCT) imaging will be performed to assess accuracy by comparing planned versus actual implant position. Outcomes will be compared against performance goals derived from literature on freehand implant placement. Receives: Diagnostic Test: Post-operative Cone Beam Computed Tomography (CBCT); Device: Straumann Falcon Dynamic Navigation System; Device: Dental Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°.
Measured: 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.
Measured: Day 0 (perioperative)
Secondary outcomes (2)
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).
Measured: 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).
Measured: Day 0 (immediately after the post-operative CBCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start22 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, multicenter clinical investigation in which all enrolled patients receive dental implant placement using the Straumann Falcon Dynamic Navigation System. Outcomes will be compared against literature-derived benchmarks for freehand surgery.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Kühl, Professor, Principal investigator, University Center for Dental Medicine, University of Basel (UZB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518615
- Sponsor's protocol ID
- CR2023_02
- Acronym
- Falcon
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of patient confidentiality concerns and company policy for industry-sponsored device trials. Only aggregate summary results will be made available through ClinicalTrials.gov and scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation
- ClinicalTrials.gov ID
- NCT07518615
- Acronym / sponsor ID
- Falcon / CR2023_02
- Conditions
- Partially Edentulous Jaw, Tooth Loss, Dental Implant
- Keywords
- Dental Implant, Dynamic Navigation, Computer-Assisted Surgery, Falcon System, Straumann, CBCT (Cone Beam Computed Tomography), Partially Edentulous Patients, Accuracy of Implant Placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, multicenter clinical investigation in which all enrolled patients receive dental implant placement using the Straumann Falcon Dynamic Navigation System. Outcomes will be compared against literature-derived benchmarks for freehand surgery.
| Arm | Type | Receives |
|---|---|---|
| Falcon Dynamic Navigation System | Experimental | Diagnostic Test: Post-operative Cone Beam Computed Tomography (CBCT), Device: Straumann Falcon Dynamic Navigation System, Device: Dental ImplantsAll participants will undergo dental implant placement using the Straumann Falcon Dynamic Navigation System. The system provides real-time, computer-assisted surgical navigation to guide implant positioning. Postoperative cone beam computed tomography (CBCT) imaging will be performed to assess accuracy by comparing planned versus actual implant position. Outcomes will be compared against performance goals derived from literature on freehand implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-operative Cone Beam Computed Tomography (CBCT)Also: Post-operative CBCT imagingAll 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). | Diagnostic test | Falcon Dynamic Navigation System |
| Straumann Falcon Dynamic Navigation SystemA 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. | Device | Falcon Dynamic Navigation System |
| Dental ImplantsSurgical 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. | Device | Falcon Dynamic Navigation System |
Primary outcome
Mean angular deviation (°) between planned and actual implant axis (Z-axis)
Time frame: Day 0 (post-operative)
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°.
Proportion of patients with ≥1 device-related serious adverse device effect (SADE)
Time frame: Day 0 (perioperative)
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.
2 secondary outcomes
Mean horizontal (XY) deviation at the implant apex (mm)
Time frame: Day 0 (immediately after the post-operative CBCT)
Mean horizontal (XY) deviation at the implant shoulder (mm)
Time frame: Day 0 (immediately after the post-operative CBCT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of patient confidentiality concerns and company policy for industry-sponsored device trials. Only aggregate summary results will be made available through ClinicalTrials.gov and scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut Straumann AG Clinical Research Department contact
Sebastian Kühl, Professor principal investigator
University Center for Dental Medicine, University of Basel (UZB)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative Cone Beam Computed Tomography (CBCT), Straumann Falcon Dynamic Navigation System and Dental Implants in people with Partially Edentulous Jaw and Tooth Loss, run by Institut Straumann AG at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Italy, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institut Straumann AG Clinical Research Department (+41 61 965 11 11, ClinicalResearch@straumann.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean angular deviation (°) between planned and actual implant axis (Z-axis) (time frame: Day 0 (post-operative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.