[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658957":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":42,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":83,"collaborators":17,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":17,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":17,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":68,"whyStopped":17,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Implant Position Transfer Accuracy (Linear deviations)","by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software. Linear deviations (x-, y-, and z-axes)","Immediately after impression procedures following implant placement (same study visit).",[14],{"measure":15,"description":16,"timeFrame":12},"Implant Position Transfer Accuracy (Angular deviations)","Accuracy of implant position transfer will be assessed by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NON_RANDOMIZED","CROSSOVER","Each participant will undergo both conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework after implant placement. The accuracy of both techniques will be compared within the same participant.","DIAGNOSTIC",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","Outcome assessment will be performed by comparing STL datasets using Geomagic Control X software. The outcome assessor will be blinded to the impression technique whenever feasible.",[27],"OUTCOMES_ASSESSOR","The passive fit of full-arch implant-supported prostheses is a critical factor influencing the long-term success of implant rehabilitation. Because dental implants lack a periodontal ligament, inaccuracies in transferring implant positions may result in framework misfit, leading to biological and mechanical complications such as screw loosening, component fracture, or implant failure. Conventional splinted open-tray impressions are considered the reference standard for full-arch implant impressions; however, they are technique-sensitive, time-consuming, and susceptible to material distortion and operator-related errors.\n\nAdvances in digital dentistry have enabled the use of intraoral scanners for implant impressions. Nevertheless, complete-arch digital scanning remains challenging because cumulative stitching errors may reduce scanning accuracy. The use of a calibrated framework has recently been proposed to improve the accuracy of complete-arch intraoral scanning by providing stable geometric reference points during image acquisition. Although promising, clinical evidence comparing this technique with the conventional splinted open-tray impression technique remains limited.\n\nThe purpose of this crossover clinical trial is to compare the accuracy of conventional splinted open-tray impressions and intraoral digital scanning using a calibrated framework in completely edentulous patients receiving full-arch implant rehabilitation.\n\nTwenty healthy completely edentulous patients will be recruited. Following implant placement, each participant will undergo both impression techniques. The conventional workflow will consist of a verified splinted open-tray implant impression, while the digital workflow will involve intraoral scanning using a calibrated stock framework attached to implant scan bodies. STL datasets obtained from both techniques will be analyzed using Geomagic Control X software. The digital models will be superimposed to assess linear deviations along the x-, y-, and z-axes, angular deviations, and global three-dimensional deviations. The results will be statistically analyzed to determine whether the calibrated framework-assisted digital workflow provides transfer accuracy comparable to or greater than the conventional impression technique.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Conventional Splinted Open-Tray Impression","ACTIVE_COMPARATOR","Participants will undergo a conventional verified splinted open-tray implant impression following implant placement. Impression copings will be splinted using dental floss and autopolymerizing resin, and a polyvinyl siloxane (PVS) impression will be made. The resulting master cast will be digitized using a laboratory scanner to generate an STL file for accuracy assessment.",[35],"Other: Conventional Splinted Open-Tray Implant Impression",{"label":37,"type":38,"description":39,"interventionNames":40},"Intraoral Digital Scanning with Calibrated Framework","EXPERIMENTAL","Participants will undergo intraoral digital scanning using an intraoral scanner and a calibrated stock framework attached to implant scan bodies after implant placement. The generated STL file will be compared with the conventional impression using Geomagic Control X software to evaluate transfer accuracy.",[41],"Other: Intraoral Digital Scanning Using a Calibrated Framework",[43,49],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Conventional Splinted Open-Tray Implant Impression","A conventional verified splinted open-tray implant impression will be performed after implant placement. Multi-unit impression copings will be splinted using dental floss and autopolymerizing resin, followed by a polyvinyl siloxane (PVS) impression. The master cast will be fabricated, verified, and scanned with a laboratory scanner to generate an STL file for accuracy analysis.",[31],[48],"Conventional Implant Impression Open-Tray Impression Splinted Open-Tray Technique",{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Intraoral Digital Scanning Using a Calibrated Framework","An intraoral digital impression will be obtained after implant placement using an intraoral scanner and a calibrated stock framework attached to implant scan bodies. The resulting STL dataset will be compared with the conventional impression using Geomagic Control X software to evaluate linear, angular, and global deviations in implant position transfer accuracy.",[37],[54],"Calibrated Framework Technique Intraoral Digital Impression Full-Arch Intraoral Scanning",[56],{"name":57,"affiliation":5,"role":58},"osama asker, PHD","STUDY_CHAIR",[60],{"name":61,"role":62,"phone":63,"phoneExt":17,"email":64},"noor alhuda raheem, BDS","CONTACT","01044487126","nooralkhalil95@yahoo.com",[66],{"facility":67,"status":68,"city":69,"state":17,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Noor Alhuda Rahemm Khalil","RECRUITING","Al Mansurah","12345","Egypt","EG",{"type":74,"coordinates":75},"Point",[76,77],31.38069,31.03637,{"lat":77,"lon":76},[80],{"name":57,"role":62,"phone":81,"phoneExt":17,"email":82},"01010848407","osamaasker@gmail.com",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Noor Elhoda Alkhalil","Principle Investigator","100658957","accuracy-of-the-calibrated-framework-for-intra-oral-full-arch-scan-a-cross-over-study-100658957",false,"NCT07858682","Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)","Accuracy of the Calibrated Framework for Intraoral Full-Arch Scanning Compared With Conventional Splinted Open-Tray Impression in Edentulous Patients: A Crossover Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Completely edentulous maxilla and mandible for at least 6 months following the last tooth extraction.\n* Angle's Class I maxillomandibular relationship with adequate interarch space.\n* Sufficient residual alveolar bone quantity and quality to receive dental implants.\n* Good oral hygiene.\n* Free from uncontrolled systemic diseases or conditions that may interfere with implant osseointegration.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Temporomandibular joint disorders or parafunctional habits.\n* Heavy smokers.\n* Uncontrolled systemic diseases.\n* History of chemotherapy or radiotherapy to the head and neck region.\n* Poor neuromuscular coordination.\n* Localized bone defects that could compromise implant placement.","ALL","35 Years","60 Years",{"count":98,"type":99},20,"ESTIMATED","INTERVENTIONAL",[102],"NA","This crossover clinical trial aims to compare the accuracy of conventional splinted open-tray implant impressions with intraoral digital scanning using a calibrated framework in completely edentulous patients rehabilitated with full-arch implant-supported prostheses. Accurate transfer of implant positions is essential for achieving a passive fit of the prosthetic framework and minimizing biological and mechanical complications.\n\nTwenty healthy completely edentulous patients requiring full-arch implant rehabilitation will be enrolled. Each participant will undergo both conventional and digital impression techniques following implant placement, allowing direct within-subject comparison. The conventional technique consists of a verified splinted open-tray impression, while the digital technique uses an intraoral scanner in combination with a calibrated stock framework.\n\nThe accuracy of the two impression techniques will be evaluated by superimposing the resulting STL files using Geomagic Control X software. Linear deviations in the x-, y-, and z-axes, angular deviations, and global deviations will be measured and compared. The findings of this study are expected to provide clinical evidence regarding the accuracy of calibrated framework-assisted intraoral scanning compared with the conventional impression technique for full-arch implant rehabilitation.",[105,106],"Edentulism","Dental Implants",[108,109,110,111],"Calibrated Framework Implant Impression Accuracy","CAD\u002FCAM","Implant Impression Accuracy","Dentistry","2026-09-30",{"date":114,"type":115},"2026-10-05","ACTUAL",{"date":117,"type":115},"2026-01-01",{"date":119,"type":99},"2027-04-01",{"name":5,"class":6},1]