Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:56 AM
Study NCT ID:
NCT07393269
Status:
COMPLETED
Last Update Posted:
2026-02-06
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Scannable Healing Abutments for Implant Impressions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-31', 'studyFirstSubmitDate': '2026-01-24', 'studyFirstSubmitQcDate': '2026-01-31', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three-dimensional implant positional accuracy (RMS deviation)', 'timeFrame': 'Periprocedural (single assessment, 1 week after second-stage implant surgery)', 'description': 'Root mean square (RMS) deviation (µm) between test impressions and the open-tray reference model using 3D metrology software.'}], 'secondaryOutcomes': [{'measure': 'Comparison of implant positional accuracy between impression techniques', 'timeFrame': 'Periprocedural (single assessment, 1 week after second-stage implant surgery)', 'description': 'Pairwise comparison of RMS deviation values among scannable healing abutment, open-tray, and closed-tray impression techniques'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Impression Technique', 'Intraoral Scanning', 'Partial Edentulism', 'Digital Dentistry', 'Dental Implants'], 'conditions': ['Partially Edentulous Maxilla, Mandible']}, 'descriptionModule': {'briefSummary': 'This prospective controlled clinical trial evaluates the three-dimensional positional accuracy of implant-level impressions obtained using scannable healing abutments compared with conventional open-tray and closed-tray impression techniques in partially edentulous patients with unilateral free-end saddle situations.', 'detailedDescription': 'Accurate transfer of implant position is critical for achieving passive fit of implant-supported prostheses. This study compares the trueness of implant impressions obtained using a digital workflow based on scannable healing abutments with conventional open-tray and closed-tray impression techniques. Twenty-two partially edentulous patients with unilateral distal extension ridges will undergo all three impression techniques. Three-dimensional deviations will be quantified using best-fit superimposition and root mean square analysis, with the open-tray technique serving as the reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partially edentulous patients with unilateral free-end saddle (Kennedy Class II)\n* Adequate bone for two implants\n* Good systemic health\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Active periodontal disease\n* Poor oral hygiene\n* Parafunctional habits\n* Temporomandibular disorders\n* Heavy smoking (\\>10 cigarettes/day)'}, 'identificationModule': {'nctId': 'NCT07393269', 'briefTitle': 'Accuracy of Scannable Healing Abutments for Implant Impressions', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Accuracy of Implant Impression Techniques Using Scannable Healing Abutments Versus Conventional Methods. A Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '33-6-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scannable Healing Abutment Digital Impression', 'description': 'Intraoral digital impression using scannable healing abutments and an intraoral scanner.', 'interventionNames': ['Procedure: Digital implant impression using scannable healing abutments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open-Tray Conventional Impression', 'description': 'Conventional splinted open-tray implant impression using polyvinyl siloxane.', 'interventionNames': ['Procedure: Open-tray implant impression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closed-Tray Conventional Impression', 'description': 'Conventional closed-tray implant impression using polyvinyl siloxane.', 'interventionNames': ['Procedure: Closed-tray implant impression']}], 'interventions': [{'name': 'Digital implant impression using scannable healing abutments', 'type': 'PROCEDURE', 'description': 'Digital acquisition of implant position using intraoral scanning of scannable healing abutments following second-stage surgery.', 'armGroupLabels': ['Scannable Healing Abutment Digital Impression']}, {'name': 'Open-tray implant impression', 'type': 'PROCEDURE', 'description': 'Conventional open-tray implant-level impression using splinted impression copings and polyvinyl siloxane material.', 'armGroupLabels': ['Open-Tray Conventional Impression']}, {'name': 'Closed-tray implant impression', 'type': 'PROCEDURE', 'description': 'Conventional closed-tray implant-level impression using transfer copings and polyvinyl siloxane material.', 'armGroupLabels': ['Closed-Tray Conventional Impression']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared. The data generated in this study include identifiable clinical and radiographic measurements that are specific to the study protocol and participants. De-identified aggregate data are reported in the published manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherif Aly Sadek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sherif Aly Sadek', 'investigatorAffiliation': 'Cairo University'}}}}