[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632817":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":111,"collaborators":29,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":29,"enrollmentInfo":123,"targetDuration":29,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Institut Straumann AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Diagnostic Test: Post-operative Cone Beam Computed Tomography (CBCT)","Device: Straumann Falcon Dynamic Navigation System","Device: Dental Implants",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","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 Patient-specific).",[9],[23],"Post-operative CBCT imaging",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","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.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"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.",[9],[35],{"name":36,"affiliation":37,"role":38},"Sebastian Kühl, Professor","University Center for Dental Medicine, University of Basel (UZB)","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Institut Straumann AG Clinical Research Department","CONTACT","+41 61 965 11 11","ClinicalResearch@straumann.com",[46,64,80,96],{"facility":47,"status":48,"city":49,"state":29,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Verwijscentrum Parodontologie Gent","RECRUITING","Ghent","9000","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],3.71667,51.05,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":29,"email":63},"Maarten Glibert","+32 9 220 3779","maarten.glibert@ugent.be",{"facility":65,"status":66,"city":67,"state":29,"zip":29,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Studio Dentistico Lorenzi","NOT_YET_RECRUITING","Segni","Italy","IT",{"type":54,"coordinates":71},[72,73],13.01934,41.68893,{"lat":73,"lon":72},[76],{"name":77,"role":42,"phone":78,"phoneExt":29,"email":79},"Claudia Lorenzi","+39 06 976 8360","claudialorenzimartinez@gmail.com",{"facility":81,"status":66,"city":82,"state":29,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Erasmus Medical Center","Rotterdam","3015","Netherlands","NL",{"type":54,"coordinates":87},[88,89],4.47917,51.9225,{"lat":89,"lon":88},[92],{"name":93,"role":42,"phone":94,"phoneExt":29,"email":95},"Justin Pijpe","+31 641 397 764","j.pijpe@erasmusmc.nl",{"facility":97,"status":48,"city":98,"state":29,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"University of Basel, UZB","Basel","4058","Switzerland","CH",{"type":54,"coordinates":103},[104,105],7.57327,47.55839,{"lat":105,"lon":104},[108],{"name":36,"role":42,"phone":109,"phoneExt":29,"email":110},"+41 61 267 2525","sebastian.kuehl@unibas.ch",{"type":112,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100632817","clinical-safety-and-effectiveness-of-the-straumann-dynamic-navigation-system-falcon-100632817",false,"NCT07518615","Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon","Clinical Safety and Effectiveness of Straumann Dynamic Navigation System (Falcon): a Prospective Multicenter and Multinational Clinical Investigation","Falcon","Inclusion Criteria:\n\n* Patients of either sex, ≥ 18 years old.\n* Partially edentulous patients requiring at least one dental implant.\n* Suitable clinical situation as judged by the investigator (e.g., satisfactory soft and hard tissue conditions and occlusion).\n* Ability to understand and sign the informed consent form.\n* Willingness and ability to participate in the planned study program.\n\nExclusion Criteria:\n\n* Fully edentulous patients.\n* 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).\n* Contraindications for dental implant treatment as per the implant Instructions for Use.\n* Contraindications listed in the Instructions for Use of the Straumann Falcon system.\n* Pregnant women or women planning pregnancy during study participation.","ALL","18 Years",{"count":124,"type":125},75,"ESTIMATED","INTERVENTIONAL",[128],"NA","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.\n\nThe 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.\n\nThe 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.",[131,132,133],"Partially Edentulous Jaw","Tooth Loss","Dental Implant",[133,135,136,137,138,139,140,141,142],"Dynamic Navigation","Computer-Assisted Surgery","Falcon System","Straumann","CBCT (Cone Beam Computed Tomography)","Partially Edentulous Patients","Accuracy of Implant Placement","Post-Market Clinical Investigation","2026-04-02",{"date":145,"type":146},"2026-04-08","ACTUAL",{"date":148,"type":146},"2026-01-22",{"date":150,"type":125},"2027-04",{"name":5,"class":6},4]