Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:39 AM
Study NCT ID:
NCT07462156
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Driven Digital Self-Assessment Framework for Preclinical Tooth Preparation
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in preparation scores', 'timeFrame': 'Up to 5 weeks', 'description': 'Preparations were scored with a prespecified 10-item rubric derived from ADEX criteria for mandibular first molar metal-ceramic crown preparation (overall score 0-10). Each item was rated on a 3-level scale (0, 0.5, or 1) and summed to obtain a total score'}, {'measure': 'RMS deviation from the ideal preparation', 'timeFrame': 'Up to 5 weeks', 'description': 'all the resulting TT-STL files across all sessions (from 1-5) of the study of the three groups of prepared teeth were compared with the ideal preparation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Education']}, 'descriptionModule': {'briefSummary': 'This study aims to compare traditional faculty-based assessment with two AI-assisted digital self-assessment software programs for evaluating tooth preparations for metal-ceramic crowns for undergraduate dental preclinical students at College of Dentistry El Alamein, AAST in terms of: (1) Accuracy of preparation outcomes, (2) Student learning outcomes over a training period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '20 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Third-year preclinical dental student\n* Completion of the fixed prosthodontics tooth-preparation course.\n* No prior formal training or use of digital 3D tooth-preparation assessment software.\n\nExclusion Criteria:\n\n* previous repetition of the course\n* Substantial prior experience with digital metrology/3D inspection software\n* Inability to attend all scheduled training and examination sessions.'}, 'identificationModule': {'nctId': 'NCT07462156', 'briefTitle': 'AI-Driven Digital Self-Assessment Framework for Preclinical Tooth Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'IntelliPrep: An AI-Driven Digital Self-Assessment Framework for Preclinical Tooth Preparation-A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '420-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital assessment 1', 'interventionNames': ['Other: Non-metrology-grade digital group (NMG)']}, {'type': 'EXPERIMENTAL', 'label': 'Digital assessment 2', 'interventionNames': ['Other: metrology-grade digital group (MG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional assessment', 'interventionNames': ['Other: Traditional group (TG)']}], 'interventions': [{'name': 'Non-metrology-grade digital group (NMG)', 'type': 'OTHER', 'description': 'Students in NMG used a license-free 3D comparison workflow (Medit Link/Compare, Compare tool; Medit Compare v3.4.9; Medit) to superimpose the prepared-tooth scan (TT-STL) onto the unprepared reference scan (RTS-STL).', 'armGroupLabels': ['Digital assessment 1']}, {'name': 'metrology-grade digital group (MG)', 'type': 'OTHER', 'description': 'Students in MG used metrology-grade 3D inspection software (Geomagic Control X v2018.1.1; 3D Systems)to superimpose TT-STL onto RTS-STL. Initial Alignment was performed followed by Best Fit Alignment (iterative closest point registration).', 'armGroupLabels': ['Digital assessment 2']}, {'name': 'Traditional group (TG)', 'type': 'OTHER', 'description': 'Students in TG assessed reduction with a silicone putty index and a periodontal probe across the previously predefined regions. Feedback was provided by experienced instructors (≥5 years of clinical teaching experience) using the same regional assessment approach.', 'armGroupLabels': ['Conventional assessment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'El Alamein', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahinour Yousry, PhD', 'role': 'CONTACT', 'email': 'dr.mahinour.ahmed@aast.edu'}, {'name': 'Mahinour Yousry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'College of Dentistry El Alamein - AAST', 'geoPoint': {'lat': 30.83007, 'lon': 28.95502}}], 'centralContacts': [{'name': 'Mahinour Yousry, PhD', 'role': 'CONTACT', 'email': 'dr.mahinour.ahmed@aast.edu', 'phone': '+2 01060080088'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Dental Public Health and biostatistical consultanat', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}