[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659282":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":38,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":77,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":17,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":62,"whyStopped":17,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Menoufia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Linear trueness of complete-arch implant scans","Linear trueness will be assessed as the three-dimensional Euclidean deviation between corresponding implant positions in the reference digital dataset and each experimental scan dataset. For each participant, the mean linear deviation across the four implants will be calculated for each scanning protocol. Lower deviation values indicate greater trueness.","Immediately after completion of each scanning protocol",[14],{"measure":15,"description":16,"timeFrame":12},"Angular trueness of complete-arch implant scans","Angular trueness will be assessed as the angular deviation between the corresponding longitudinal axes of the implants in the reference digital dataset and each experimental scan dataset. For each participant, the mean angular deviation across the four implants will be calculated for each scanning protocol. Lower angular deviation values indicate greater trueness.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","CROSSOVER","This is a randomized, two-period crossover clinical study. Each participant will undergo both complete-arch implant scanning protocols (Scan Pro and IoConnect), with the order of the two protocols determined by computer-generated randomization. Each participant will therefore serve as their own control. Linear and angular scan trueness and chairside scanning time will be compared between the two protocols.","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","Complete-arch implant scanning can be challenging because errors during image acquisition and stitching may accumulate across the arch. Non-calibrated splinting techniques have been introduced to stabilize implant scan bodies and improve the reliability of complete-arch digital implant impressions without requiring scanner-specific calibration.\n\nThis randomized crossover clinical study will evaluate and compare two non-calibrated splinting systems, IoConnect and Scan Pro, for complete-arch implant scanning in completely edentulous patients rehabilitated with implant-supported prostheses.\n\nEligible participants will have a completely edentulous maxilla or mandible and four well-integrated implants connected to multiunit abutments. Patients with fewer or more than four implants, failed implants, active peri-implant infection or suppuration, or limited mouth opening will be excluded.\n\nA verified conventional splinted implant impression will first be obtained to establish a reference cast. Open-tray impression copings will be splinted intraorally using chemically polymerized acrylic resin, and the definitive impression will be made using polyvinyl siloxane impression material. A verification jig will be fabricated and used to confirm the passive fit of the reference cast. The verified reference cast will subsequently be digitized using a calibrated laboratory scanner to generate the reference digital model.\n\nEach participant will undergo both digital scanning protocols. The order of the two protocols will be randomized using a computer-generated randomization sequence to minimize potential order and operator learning effects.\n\nFor the Scan Pro workflow, implant scan bodies will be connected to the multiunit abutments, and adjustable arms will be added to provide optical splinting. The complete-arch implant scan will then be obtained using an intraoral scanner.\n\nFor the IoConnect workflow, peri-implant soft-tissue anatomy will first be captured using healing abutments. Following removal of the healing abutments, horizontal IoConnect scan bodies will be attached to the multiunit abutments and a complete-arch implant scan will be obtained using the same intraoral scanner. The soft-tissue scan and optical marker scan will subsequently be merged using the dedicated software to generate the final digital implant impression.\n\nTo standardize the datasets and minimize the influence of differences in scan-body geometry and digital mesh reconstruction, the scan bodies captured during scanning will be replaced with the corresponding manufacturer-provided CAD library files. An identical implant-supported bar framework will then be virtually designed for each dataset. The resulting STL files will be analyzed using three-dimensional reverse-engineering software.\n\nAccuracy will be assessed by comparing the experimental datasets with the reference digital model. Linear discrepancy will be determined as the three-dimensional Euclidean distance between corresponding implant measurement points, while angular discrepancy will be determined as the angle between corresponding implant longitudinal axes. Measurements will be obtained for all four implants in each dataset, and mean linear and angular discrepancies will be calculated.\n\nChairside time associated with the digital scanning procedures will also be evaluated. Statistical analysis will include assessment of data normality and comparison of the paired linear and angular deviations between the two scanning protocols using a paired t-test, with statistical significance set at α = .05.",[27,34],{"label":28,"type":29,"description":30,"interventionNames":31},"Scan Pro → IoConnect","EXPERIMENTAL","Participants randomized to this sequence will undergo complete-arch implant scanning using the Scan Pro noncalibrated splinting system first, followed by complete-arch implant scanning using the IoConnect noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization.",[32,33],"Device: Scan Pro","Device: IoConnect",{"label":35,"type":29,"description":36,"interventionNames":37},"IoConnect → Scan Pro","Participants randomized to this sequence will undergo complete-arch implant scanning using the IoConnect noncalibrated splinting system first, followed by complete-arch implant scanning using the Scan Pro noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization.",[32,33],[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":17},"DEVICE","Scan Pro","Complete-arch implant scanning using the Scan Pro noncalibrated splinting system and an intraoral scanner. The scan bodies are connected using adjustable arms to provide optical splinting, and the resulting digital impression is exported as an STL file for accuracy assessment.",[35,28],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":17},"IoConnect","Complete-arch implant scanning using the IoConnect noncalibrated splinting system and an intraoral scanner. The workflow includes acquisition of peri-implant soft-tissue anatomy followed by acquisition of the horizontal optical markers. The datasets are merged using the dedicated software to generate the final digital implant impression.",[35,28],[49],{"name":50,"affiliation":51,"role":52},"Mohammed El-Sawy, PhD","Menoufia, Faculty of Dentistry","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":17,"email":58},"Mohammed A. El-Sawy, PhD","CONTACT","00201061314522","Dr_Sawy@windowslive.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Faculty of Dentistry, Menoufia University","RECRUITING","Shibīn al Kawm","Menoufia","2266166","Egypt","EG",{"type":69,"coordinates":70},"Point",[71,72],31.00904,30.55258,{"lat":72,"lon":71},[75],{"name":55,"role":56,"phone":57,"phoneExt":17,"email":76},"mohamed.elsawy@dent.menofia.edu.eg",{"type":52,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Mohammed El-Sawy","Assistant Professor",[81],{"name":82,"class":6},"Mansoura University","100659282","accuracy-of-complete-arch-implant-scans-using-non-calibrated-splinting-scanbodies-100659282",false,"NCT07862218","Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies","Accuracy of Complete-Arch Implant Scans Using Two Non-Calibrated Splinting Systems: A Randomized Crossover Clinical Study of IoConnect and Scan Pro","Inclusion Criteria\n\n* Adults aged 18 years or older.\n* Completely edentulous maxilla or mandible.\n* Four clinically stable and osseointegrated implants restored with multiunit abutments.\n* Patients with a screw-retained interim prosthesis or patients scheduled to receive a definitive complete-arch implant-supported prosthesis.\n* Ability to undergo intraoral scanning procedures and provide written informed consent.\n\nExclusion Criteria\n\n* Fewer or more than four implants in the evaluated arch.\n* Failed or clinically unstable implants.\n* Active peri-implant infection or suppuration.\n* Limited mouth opening that prevents completion of the intraoral scanning procedures.\n* Inability or unwillingness to provide written informed consent.","ALL","40 Years","70 Years",{"count":94,"type":95},24,"ESTIMATED","INTERVENTIONAL",[98],"NA","This randomized crossover clinical study will evaluate and compare the accuracy and chairside time of two non-calibrated splinting systems, IoConnect and Scan Pro, for obtaining complete-arch implant digital scans. The study will include completely edentulous patients with four well-integrated implants connected to multiunit abutments.\n\nEach participant will undergo complete-arch implant scanning using both systems, with the order of the scanning protocols determined by a computer-generated randomization sequence. The digital scans obtained with each system will be compared with a verified conventional implant impression used to establish a reference model.\n\nThe primary evaluation will focus on the accuracy of the implant scans by assessing linear and angular discrepancies between each experimental scan and the reference model. Chairside time required for the scanning procedures will also be recorded. The study will determine whether differences exist between the two non-calibrated splinting systems in terms of complete-arch implant scan accuracy.",[101],"Edentulism Complete",[103,104,105,106,107],"Complete-arch implant scanning","Intraoral scanning","Digital implant impressions","Implant scan accuracy","Noncalibrated splinting","2026-10-12",{"date":110,"type":111},"2026-10-13","ACTUAL",{"date":113,"type":111},"2026-01-01",{"date":115,"type":95},"2027-02-01",{"name":5,"class":6},1]