[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053606":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Universidad de Especialidades Espiritu Santo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"digital workflow","EXPERIMENTAL","Participants receive complete dentures fabricated by digital workflow first (intraoral scanning + CAD + 3D printing, 3 appointments), worn for 2 months, then cross over to hybrid workflow dentures for an additional 2 months.",[13],"Device: Digital Workflow Complete Denture",{"label":15,"type":16,"description":17,"interventionNames":18},"Hybrid Workflow","ACTIVE_COMPARATOR","Participants receive complete dentures fabricated by hybrid workflow first (conventional impressions + digitization + CAD + 3D printing, 5 appointments), worn for 2 months, then cross over to digital workflow dentures for an additional 2 months.",[19],"Device: Hybrid Workflow Complete Denture",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Digital Workflow Complete Denture","Complete dentures fabricated using direct intraoral scanning of edentulous ridges (TRIOS 5, 3Shape), CAD design (3Shape Dental System), 3D-printed try-in prototype (Asiga TRY resin, Asiga MAX 2 printer), and definitive 3D-printed denture (DentaBASE resin; VarseoSmile TriniQ teeth, BEGO). Completed in 3 clinical appointments.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Hybrid Workflow Complete Denture","Complete dentures fabricated using conventional preliminary and functional impressions (elastomeric materials), interocclusal registration with wax rims, conventional wax try-in, digitization of the impression\u002Fmaster model via laboratory scanner, CAD design (3Shape Dental System), and additive manufacturing of the definitive denture base (DentaBASE resin; VarseoSmile TriniQ teeth, BEGO). Completed in 5 clinical appointments.",[15],[32],{"name":33,"affiliation":5,"role":34},"Pablo Benitez, PhD","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Pablo Benitez, phd","CONTACT","+593996516891","pbenitez@uees.edu.ec",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES)","RECRUITING","Samborondón","Guayas","Ecuador","EC",{"type":50,"coordinates":51},"Point",[52,53],-79.72566,-1.96071,{"lat":53,"lon":52},[56,60,62],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":59},"Patricia Ayala Director","+593 98 851 1041","payalaa@uees.edu.ec",{"name":33,"role":61,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Andres Ullauri, Dentist","SUB_INVESTIGATOR",{"type":61,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Pablo Lenin Benitez Sellan","Research Professor","100053606","clinical-performance-and-quality-of-life-of-3d-printed-complete-dentures-under-digital-vs-hybrid-workflows-a-randomized-crossover-trial-100053606",false,"NCT07626827","Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover Trial","Clinical Success, Oral Health-Related Quality of Life, and Relationship Between Maximum Masticatory Force and Denture Wear in Complete Dentures Fabricated by Additive Manufacturing Under Digital and Hybrid Workflows: A Prospective Randomized Crossover Clinical Trial","PRINT-DENT","Inclusion Criteria:\n\n* Completely edentulous (bimaxillary)\n* Age between 50 and 90 years\n* Able to understand and sign informed consent\n* No cognitive or psychological deficits that interfere with study participation\n\nExclusion Criteria:\n\n* Unimaxillary edentulism\n* Presence of Kelly syndrome\n* Presence of flabby tissue on alveolar ridges\n* No prior experience with complete dentures\n* Chronic motor disorders that may compromise prosthetic function","ALL","50 Years","90 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"NA","This prospective randomized crossover clinical trial evaluates and compares the clinical performance and oral health-related quality of life (OHRQoL) of complete dentures fabricated through two additive manufacturing workflows - digital and hybrid - in edentulous patients attending the Dental Clinic of Universidad de Especialidades Espíritu Santo (UEES), Samborondón, Ecuador.\n\nIn the digital workflow, complete dentures are fabricated using direct intraoral scanning of edentulous ridges, CAD design, and 3D printing. In the hybrid workflow, conventional functional impressions are digitized, followed by CAD design and additive manufacturing of the definitive dentures.\n\nEach eligible participant receives two complete denture sets in a randomized crossover sequence (no washout period): Denture Set 1 is worn for 2 months, after which the participant crosses over to Denture Set 2, worn for an additional 2 months. Total active follow-up per participant is approximately 4 months. Following completion of the crossover phase, denture wear is monitored longitudinally for 12 months from the insertion of the second denture set (total study duration approximately 16 months per participant).\n\nThe study addresses three specific objectives:\n\nTo determine the clinical success rate of complete dentures fabricated by additive manufacturing under digital and hybrid workflows, evaluating retention, stability, denture base adaptation, occlusal balance, and need for clinical adjustments.\n\nTo evaluate the impact of complete denture treatment on OHRQoL using the validated OHIP-EDENT questionnaire, assessed at the insertion of each denture set and at the 2-month control of each period (4 measurement points total).\n\nTo evaluate the relationship between maximum masticatory force (T-Scan digital occlusal analysis system) and denture wear (volumetric 3D digital metrology via STL superimposition), with wear monitored over 12 months from insertion of the second denture set.",[87],"Complete Edentulism",[89,90,9,91],"hybrid workflow","complete denture","complete edentulous","2026-07-09",{"date":94,"type":95},"2026-07-13","ACTUAL",{"date":97,"type":95},"2026-07-01",{"date":99,"type":81},"2027-11-30",{"name":5,"class":6},1]