Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:36 AM
Study NCT ID:
NCT07489027
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019094', 'term': 'Dental Prosthesis, Implant-Supported'}], 'ancestors': [{'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly allocated to three equal groups (n = 9) by simple randomization:Group I: Conventional cast Co-Cr framework, Group II: CAD/CAM milled Co-Cr framework, and Group III: SLM Co-Cr framework'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of occurance of Prosthetic complications', 'timeFrame': 'after a year', 'description': 'The prosthetic complications were evaluated for the three different types of Co-Cr frameworks\n\nThe following prosthetic complications were evaluated:\n\n* abutment screw loosening\n* abutment screw fracture\n* prosthetic screw loosening\n* prosthetic screw fracture\n* acrylic teeth fracture (separation)\n* acrylic teeth wear (replacement)\n* co-cr framework fracture'}], 'secondaryOutcomes': [{'measure': 'the implant framework Passive fit', 'timeFrame': 'baseline', 'description': 'the passivity of the framework was evaluated digitally using 3D scan protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Full arch prosthesis', 'Co-Cr framework', 'CAD/CAM milling', 'Selective laser melting'], 'conditions': ['Prosthesis (Internal) Complications']}, 'descriptionModule': {'briefSummary': 'This randomized clinical study aimed to compare prosthetic complications and framework misfit associated with three different fabrication techniques of cobalt-chromium frameworks-conventional casting, CAD/CAM milling, and selective laser melting (SLM)-used in maxillary and mandibular full-arch implant-supported acrylic screw-retained restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Six osseointegrated maxillary and six mandibular implants\n\n * No clinical or radiographic signs of implant failure\n * Good systemic health\n * Normal maxillomandibular relationship and acceptable oral hygiene\n\nExclusion Criteria:\n\n* • Implant failure\n\n * Unfavorable occlusal relationships\n * Poor compliance or inability to attend follow-up'}, 'identificationModule': {'nctId': 'NCT07489027', 'briefTitle': 'Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparison of Prosthetic Complications and Framework Misfit Among Different Cobalt-Chromium Framework Fabrication Techniques in Maxillary and Mandibular Full-Arch Implant-Supported Acrylic Screw-Retained Restorations: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'A05012023RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I: Conventional cast Co-Cr framework', 'description': 'patients received maxillary and mandibular full-arch implant fixed prosthesis with conventional casting CO-CR framework', 'interventionNames': ['Device: Implant supported prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II: CAD/CAM milled Co-Cr framework', 'description': 'patients received maxillary and mandibular full-arch implant fixed prosthesis with milled CO-CR framework', 'interventionNames': ['Device: Implant supported prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III: Selective laser melting (SLM) Co-Cr framework', 'description': 'patients received maxillary and mandibular full-arch implant fixed prosthesis with a laser-melted CO-CR framework.', 'interventionNames': ['Device: Implant supported prosthesis']}], 'interventions': [{'name': 'Implant supported prosthesis', 'type': 'DEVICE', 'description': 'All patients received maxillary and mandibular six implants to support a metal acrylic screw retained full-arch prosthesis', 'armGroupLabels': ['Group I: Conventional cast Co-Cr framework', 'Group II: CAD/CAM milled Co-Cr framework', 'Group III: Selective laser melting (SLM) Co-Cr framework']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O.Box:35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University , Faculty Of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}