[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652831":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":43,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":86,"collaborators":17,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":17,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":17,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":70,"whyStopped":17,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Passive Fit Assessed by Sheffield One-Screw Test","The framework was seated on all implants and a single distal screw was fully tightened; remaining screw sites were examined visually and tactilely for lifting, rocking, or gaps as an indicator of passive fit.","The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.",{"measure":14,"description":15,"timeFrame":16},"Passive Fit Assessed by Periapical Radiographs","Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.","The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","CROSSOVER","Each patient will sequentially receive all three impression techniques (IO-Connect, Reverse Scan Body, and conventional splinted impression) for framework fabrication and passive fit evaluation.","TREATMENT",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","Full-arch implant-supported fixed prostheses require a high degree of passive fit to avoid mechanical and biological complications. While digital impression workflows are increasingly used as alternatives to conventional splinted impressions, evidence directly comparing their clinical accuracy for complete-arch implant frameworks remains limited, particularly for the IO-Connect non-calibrated splinting system and the Reverse Scan Body technique.\n\nEight completely edentulous patients with at least four mandibular implants will be enrolled. Using a crossover design, each patient will undergo all three impression techniques: Group I (IO-Connect splinted scan bodies), Group II (Reverse Scan Body technique), and Group III (conventional splinted open-tray impression with polyvinyl siloxane and Type IV stone casts). For each technique, a corresponding implant-supported framework will be fabricated and evaluated for passivity of fit using the Sheffield one-screw test and periapical radiographs taken with a paralleling device to assess microgaps at the implant-framework interface.",[27,33,38],{"label":28,"type":29,"description":30,"interventionNames":31},"Group I: IO-Connect","ACTIVE_COMPARATOR","Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies.",[32],"Procedure: IO-Connect Digital Impression",{"label":34,"type":29,"description":35,"interventionNames":36},"Group II: Reverse Scan Body","Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique.",[37],"Procedure: Reverse Scan Body Digital Impression",{"label":39,"type":29,"description":40,"interventionNames":41},"Group III: Conventional Impression","Patients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique.",[42],"Procedure: Conventional Splinted Impression",[44,49,53],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"PROCEDURE","IO-Connect Digital Impression","Digital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I.",[28],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":17},"Reverse Scan Body Digital Impression","Digital impression obtained using the Reverse Scan Body (RSB) technique, involving extraoral scanning of scan bodies and superimposition with intraoral tissue scans, to fabricate the implant-supported framework for Group II.",[34],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":17},"Conventional Splinted Impression","Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.",[39],[58],{"name":59,"affiliation":5,"role":60},"Fatma A El-Waseef, PhD","STUDY_CHAIR",[62],{"name":63,"role":64,"phone":65,"phoneExt":17,"email":66},"Ahmed H Hazem Elsayed Helmi Atwa, BDS","CONTACT","+20 1092758696","ahmedhazem@mans.edu.eg",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":17,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Faculty of Dentistry, Mansoura University","RECRUITING","Al Mansurah","Dakahlia Governorate","Egypt","EG",{"type":76,"coordinates":77},"Point",[78,79],31.38069,31.03637,{"lat":79,"lon":78},[82,83],{"name":63,"role":64,"phone":65,"phoneExt":17,"email":66},{"name":84,"role":85,"phone":17,"phoneExt":17,"email":17},"Ahmed Hazem Elsayed Helmi Atwa, BDS","PRINCIPAL_INVESTIGATOR",{"type":85,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Ahmed Hazem Elsayed Helmi","Clinical Demonstrator, Department of Removable Prosthodontics, Faculty of Dentistry, Mansoura University","100652831","passive-fit-of-implant-supported-frameworks-digital-vs-conventional-impressions-100652831",false,"NCT07778199","Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions","Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study","Inclusion Criteria:\n\n* Completely edentulous patients requiring full-arch implant-supported fixed prosthesis\n* Age 35-70 years\n* Adequate mandibular bone to place at least four implants without major grafting\n* Ability to undergo digital scanning and radiographic evaluation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)\n* History of head\u002Fneck radiotherapy or bisphosphonate therapy\n* Active oral infection or severe bruxism\n* Strong gag reflex preventing accurate scanning\n* Poor compliance or unwillingness to attend follow-up visits","ALL","35 Years","70 Years",{"count":100,"type":101},8,"ESTIMATED","INTERVENTIONAL",[104],"NA","This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique. Eight completely edentulous patients each receiving four mandibular implants will be included. Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.",[107,108,109],"Dental Implants","Edentulous Jaw","Passive Fit",[111,112,113,114,115],"Passive fit","Implant-supported framework","Digital impression","Full-arch implant prosthesis","Crossover study","2026-08-20",{"date":118,"type":119},"2026-08-21","ACTUAL",{"date":121,"type":119},"2026-01-25",{"date":123,"type":101},"2027-01-25",{"name":5,"class":6},1]