Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT06067334
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2023-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best fit alignment to calculate 3D deviation of each impression', 'timeFrame': '3 months', 'description': '3D inspection software (Geomagic Control X) using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.'}], 'secondaryOutcomes': [{'measure': 'Passive fit', 'timeFrame': '3 months', 'description': 'Passive fit of framework will be evaluated at time of insertion (Sheffield test)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accuracy', 'implant level impression', 'abutment level impression'], 'conditions': ['Accuracy']}, 'descriptionModule': {'briefSummary': 'aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration.', 'detailedDescription': "The patient will be selected according to the following criteria:\n\n1. Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.\n2. Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.\n3. Normal maxilla mandibular relationship with adequate inter-arch space, measured by tentative jaw relation.\n4. Sufficient residual alveolar ridge.\n\nExclusion criteria include:\n\n1. Local or general contraindications for surgical procedures.\n2. Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.\n3. Severe inter-maxillary skeletal discrepancy or limited inter-arch space.\n4. Heavy smokers.\n\n * For all patients, conventional complete dentures are constructed.\n * Implants installed in the edentulous maxilla and mandible in each target position guided by stereolithographic stent. A delayed loading protocol is followed in this study.\n * After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.\n * Scan bodies' implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.\n\nAccuracy will be evaluated as follows:\n\n* 3D inspection software using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.\n* Passive fit of the framework will be evaluated at the time of insertion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.\n* Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.\n* Normal maxilla mandibular relationship with adequate inter-arch space as verified by tentative jaw relation.\n* Sufficient residual alveolar ridge.\n\nExclusion Criteria:\n\n* Local or general contraindications for surgical procedures.\n* Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.\n* Severe inter-maxillary skeletal discrepancy or limited inter-arch space.\n* Heavy smokers.'}, 'identificationModule': {'nctId': 'NCT06067334', 'briefTitle': 'Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration: Accuracy of Different Impressions Techniques on Implant and Abutment Levels (Cross-over Study)', 'orgStudyIdInfo': {'id': 'J0104023RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional (Open tray impression technique)', 'description': 'After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.', 'interventionNames': ['Other: full arch implant supported screw retained restoration with conventional impression technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital impression', 'description': 'Scan bodies implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.', 'interventionNames': ['Other: full arch implant supported screw retained restoration with conventional digital technique']}], 'interventions': [{'name': 'full arch implant supported screw retained restoration with conventional impression technique', 'type': 'OTHER', 'description': 'surgical procedures: Implant installation Prosthetic procedures: Conventional impression fabrication of full arch implant supported screw-retained restoration evaluation: Accuracy, Passive fit', 'armGroupLabels': ['Conventional (Open tray impression technique)']}, {'name': 'full arch implant supported screw retained restoration with conventional digital technique', 'type': 'OTHER', 'description': 'surgical procedures: Implant installation Prosthetic procedures: Digital impression fabrication of full arch implant-supported screw-retained restoration evaluation: Accuracy, Passive fit', 'armGroupLabels': ['Digital impression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of dentistry, mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Gamal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura university, faculty of dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of prosthodontics', 'investigatorFullName': 'Fatma mahanna', 'investigatorAffiliation': 'Mansoura University'}}}}