Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:45 PM
Study NCT ID:
NCT07403851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Scanning Technology on the Accuracy of Digitally Customized Intraradicular Attachments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'Immediately after scanning.', 'description': 'measure accuracy between the dimension of the prepared canal gained by intra-radicular impression and the dimension of the prepared canal directly by two different types of intraoral scanners'}], 'secondaryOutcomes': [{'measure': 'Patient-reported comfort', 'timeFrame': 'Immediately after impression taking and scanning.', 'description': 'Patient-reported comfort (assessed via a Likert scale questionnaire) Scaled from 0-100 The highest score means excellent The lowest score means unsatisfactory'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scanning Devices']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the accuracy of intra-radicular attachments fabricated by direct scanning using three different scanners in vivo. The primary outcome will be the accuracy of the fabricated attachments, while secondary outcomes will includepatient-reported comfort during procedure of taking intraradicular attachment conventional impression and direct scanning.', 'detailedDescription': 'The fabrication of intra-radicular attachments is a critical step in restoring endodontically treated teeth. The accuracy of these restorations directly impacts their clinical performance, including retention, marginal fit, and long-term success. With advancements in digital dentistry, intraoral scanners (IOS) have become increasingly popular for direct scanning of intra-radicular preparations. However, the accuracy of these scanners varies depending on their technology, software, and clinical conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 18-65 years.\n2. Endodontically treated teeth requiring intra-radicular attachments.\n3. Adequate oral hygiene .\n4. Partially edentulous case ( Compromised remaining teeth that cannot serve as abutments for traditional RPD.\n5. Periodontally Compromised Teeth: When some teeth have reduced bone support but can still be maintained as overdenture abutments with proper treatment.\n\nExclusion Criteria:\n\n1. Severely Compromised Remaining Teeth: If the remaining teeth have poor prognosis due to extensive decay or severe periodontal disease.\n2. Severe Bone Loss Around Abutment Teeth: If the remaining teeth do not provide adequate support, they may fail early, leading to additional complications.\n3. Severe Malocclusion: Where occlusal discrepancies make overdenture placement difficult.\n4. Limited inter-arch Space: cann't accommodate the overdenture components. 5 .Poor Oral Hygiene: increase the risk of decay or periodontal issues in retained abutments."}, 'identificationModule': {'nctId': 'NCT07403851', 'briefTitle': 'Effect of Scanning Technology on the Accuracy of Digitally Customized Intraradicular Attachments', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Scanning Technology on the Accuracy of Digitally Customized Intraradicular Attachments: A Cross Overstudy', 'orgStudyIdInfo': {'id': 'Effect of Scanning Technology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Indirect scanning by desktop scanner (for the conventional impression)', 'interventionNames': ['Device: 3 shape desktop scanner']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'Intraoral scanning by Intraoral scanner A', 'interventionNames': ['Device: SHINING 3D intraoral scanner']}, {'type': 'EXPERIMENTAL', 'label': 'Group III', 'description': 'Intraoral scanning by Intraoral scanner B', 'interventionNames': ['Device: Planmeca Emerald S intraoral scanner']}], 'interventions': [{'name': '3 shape desktop scanner', 'type': 'DEVICE', 'description': 'Scanning of intra-radicular impression by desktop scanner', 'armGroupLabels': ['Group I']}, {'name': 'SHINING 3D intraoral scanner', 'type': 'DEVICE', 'description': 'Direct scanning of the intra-radicular canal by Intraoral scanner A', 'armGroupLabels': ['Group II']}, {'name': 'Planmeca Emerald S intraoral scanner', 'type': 'DEVICE', 'description': 'Direct scanning of the intra-radicular canal by Intraoral scanner B', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Afnan GM Qamar', 'role': 'CONTACT', 'email': 'afnan.gamal98@gmail.com', 'phone': '01158902700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant in removable prosthodontic department', 'investigatorFullName': 'Afnan Gamal Mohamed Qamar', 'investigatorAffiliation': 'October 6 University'}}}}