[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617207":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":31,"locations":45,"responsibleParty":65,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":31,"enrollmentInfo":79,"targetDuration":31,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":48,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CBCT-STL Alignment (Medicalfit 1.0)","ACTIVE_COMPARATOR","Participants in this arm will receive a definitive, screw-retained, implant-supported full-arch prosthesis fabricated using a digital workflow based on manual alignment of CBCT and intraoral scan (STL) datasets. Scannable healing abutments (Tissue Shapers-IF; MedicalFit, Úbeda, Spain) will be connected to multi-unit abutments according to the manufacturer's instructions. An intraoral scan and a CBCT scan will be obtained and manually aligned by the operator during the CAD design stage using reference points visible in both datasets. Prosthetic framework passivation is performed manually during the CAD phase. The definitive prosthesis is designed and manufactured using CAD\u002FCAM technology in monolithic zirconia (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein). This workflow is fully operator-dependent and serves as an active comparator.",[13],"Procedure: CBCT-STL Alignment Workflow",{"label":15,"type":10,"description":16,"interventionNames":17},"Splint-Guided Alignment (Medicalfit 2.0)","Participants in this arm will receive a definitive, screw-retained, implant-supported full-arch prosthesis fabricated using a digital workflow that incorporates a rigid reference splint with metallic abutment cylinders to assist manual dataset alignment. Scannable healing abutments (Tissue Shapers-IF; MedicalFit, Úbeda, Spain) are connected to multi-unit abutments. A calibrated rigid splint is intraorally adapted and connected to the abutment cylinders, and both intraoral and splint scans are obtained. The acquired datasets are imported into CAD software, where CBCT-STL registration is performed manually using the splint as a reference. The definitive prosthetic framework is designed and manufactured using CAD\u002FCAM technology in monolithic zirconia (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein). This workflow remains operator-dependent and serves as an active comparator.",[18],"Procedure: Splint-Guided Alignment Workflow",{"label":20,"type":21,"description":22,"interventionNames":23},"Automated AI-Assisted CBCT-STL Alignment (Medicalfit 3.0)","EXPERIMENTAL","Participants in this arm will receive a definitive, screw-retained, implant-supported full-arch prosthesis fabricated using an automated AI-assisted digital workflow. Scannable healing abutments (Tissue Shapers-IF; MedicalFit, Úbeda, Spain) are connected to multi-unit abutments according to the manufacturer's protocol. An intraoral scan and a CBCT scan are acquired and imported into dedicated AI-assisted software (Pdental; MedicalFit, Úbeda, Spain). The software automatically detects the scan bodies and performs CBCT-STL dataset alignment prior to CAD\u002FCAM prosthesis fabrication. The definitive prosthesis is designed and manufactured using CAD\u002FCAM technology in monolithic zirconia (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein). This workflow minimizes operator involvement and represents the experimental intervention.",[24],"Procedure: Automated AI-Assisted CBCT-STL Alignment Workflow",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","CBCT-STL Alignment Workflow","This procedure consists of a fully digital workflow for fabricating a screw-retained, implant-supported full-arch prosthesis using manual alignment between CBCT and intraoral scan (STL) data. Scannable healing abutments (Tissue Shapers-IF; MedicalFit, Úbeda, Spain) are attached to multi-unit abutments torqued to 10 Ncm. A CBCT scan and an intraoral scan are acquired and manually aligned in CAD software using operator-defined reference points. Passive fit is adjusted manually during the CAD design stage. The definitive framework is milled from monolithic zirconia (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein). This workflow is operator-dependent and serves as the control procedure.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Splint-Guided Alignment Workflow","This procedure employs a rigid reference splint with metallic abutment cylinders to guide dataset alignment for full-arch prosthesis fabrication. Scannable healing abutments (Tissue Shapers-IF; MedicalFit, Úbeda, Spain) are connected to multi-unit abutments torqued to 10 Ncm. The splint is attached intraorally and scanned extraorally to capture implant positions. The splint and intraoral scans (STL) are imported into CAD software, where manual alignment is performed using the splint as a reference. The final monolithic zirconia framework (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein) is designed and milled via CAD\u002FCAM. This workflow is operator-dependent and used as an active comparator.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Automated AI-Assisted CBCT-STL Alignment Workflow","This procedure uses AI-assisted software (Pdental, MedicalFit, Úbeda, Spain) to automate the alignment of CBCT and intraoral scan (STL) datasets for full-arch prosthesis fabrication. After placement of scannable healing abutments (Tissue Shapers-IF; MedicalFit), intraoral and CBCT scans are obtained. The software automatically detects healing abutments, performs CBCT-STL registration, and corrects deviations greater than 120 µm to achieve passive fit within clinically acceptable limits. The corrected digital model is exported in STL format for CAD design and CAM milling of a monolithic zirconia screw-retained prosthesis (IPS e.max ZirCAD Prime; Ivoclar, Schaan, Liechtenstein). This workflow minimizes operator dependency based on an AI-assisted automation. .",[20],[41],{"name":42,"affiliation":43,"role":44},"Miguel A Gómez Polo, DDS, PhD","School of Dentistry, Complutense University of Madrid. Pza Ramon y Cajal S\u002FN. 28040 Madrid, Spain","STUDY_DIRECTOR",[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Complutense of Madrid","RECRUITING","Madrid","28040","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-3.70256,40.4165,{"lat":57,"lon":56},[60],{"name":61,"role":62,"phone":63,"phoneExt":31,"email":64},"Miguel A Gomez-Polo, DDS, PhD, DDS","CONTACT","+34 91 394 2029","mgomezpo@ucm.es",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Miguel Gómez Polo","Associate Professor of Prosthodontics, Department of Conservative Dentistry and Prosthodontics, Faculty of Dentistry, Universidad Complutense de Madrid","100617207","passive-fit-of-implant-supported-complete-arch-prostheses-using-digital-workflows-100617207",false,"NCT07315620","Passive Fit of Implant-Supported Complete-Arch Prostheses Using Digital Workflows","Evaluation of Passive Fit in Implant-Supported Complete-Arch Prostheses Using Three Digital Workflows, Including an Automated AI-Assisted Protocol: A Randomized Clinical Trial","MFS03-Pdental","Inclusion Criteria:\n\n1. Adults aged 18 years or older.\n2. Patients indicated for fixed implant-supported full-arch rehabilitation in the maxilla or mandible.\n3. Presence of clinically stable, osteointegrated titanium implants suitable for prosthetic rehabilitation.\n4. Absence of clinical or radiographic signs of peri-implant disease.\n5. Ability to understand the study procedures and provide written informed consent.\n6. Willingness and ability to attend all required clinical visits and evaluations.\n\nExclusion Criteria:\n\n1. Presence of peri-implant mucositis or peri-implantitis at the time of evaluation.\n2. Implant mobility or implant positioning that prevents proper prosthetic rehabilitation.\n3. Uncontrolled systemic medical conditions that could interfere with study participation or prosthetic treatment.\n4. Cognitive, psychological, or medical conditions that limit the ability to comply with study procedures.\n5. Inability to complete the required clinical evaluations or follow the study protocol, as judged by the investigator.","ALL","18 Years",{"count":80,"type":81},30,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this clinical trial is to evaluate and compare three digital workflows for the fabrication of definitive implant-supported full-arch prostheses in adult patients requiring fixed implant rehabilitation.\n\nThe main questions it aims to answer are:\n\n* Does an automated AI-assisted digital workflow improve the passive fit of definitive full-arch implant-supported prostheses compared with manual and splint-guided alignment workflows?\n* Are there differences in marginal, geometric, mechanical, and radiographic passivity among the three digital workflows? Researchers will compare manual CBCT-STL alignment, splint-guided alignment, and automated AI-assisted CBCT-STL alignment to see if the degree of digital workflow automation affects the passive fit of definitive full-arch implant-supported prostheses.\n\nParticipants will:\n\n* Be adults (18 years and older) indicated for fixed implant-supported full-arch rehabilitation.\n* Receive a definitive, screw-retained, full-arch implant-supported prosthesis fabricated using one of the three assigned digital workflows.\n* Undergo standardized clinical and radiographic assessments at the time of definitive prosthesis placement to evaluate prosthesis passive fit.",[87],"Prosthesis and Implant Dentistry",[89,90,91,92,93,94],"Implant-Supported Prosthesis","Full-Arch Rehabilitation","Passive Fit","Digital Workflow","Computer-Aided Design and Manufacturing (CAD\u002FCAM)","AI-Assisted Workflow","2026-01-08",{"date":97,"type":98},"2026-01-09","ACTUAL",{"date":100,"type":81},"2026-01-01",{"date":102,"type":81},"2027-03-01",{"name":5,"class":6},1]