Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-21 @ 2:52 AM
Study NCT ID:
NCT03103802
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners
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': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-09', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-01', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy', 'timeFrame': '6 months', 'description': 'evaluation of the accuracy of digital models obtained using scanners'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontics']}, 'descriptionModule': {'briefSummary': 'This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients seeking orthodontic treatment permanent dentition\n\nExclusion Criteria:\n\n* deciduous or mixed dentition cleft lip and palate patients'}, 'identificationModule': {'nctId': 'NCT03103802', 'briefTitle': 'Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)', 'orgStudyIdInfo': {'id': 'CEBD-CU-2017-03-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-oral scanning', 'interventionNames': ['Device: intra-oral digital scanner and extra-oral digital scanner']}, {'type': 'EXPERIMENTAL', 'label': 'extra-oral scanning of the plaster model obtained via alginate', 'interventionNames': ['Device: intra-oral digital scanner and extra-oral digital scanner']}, {'type': 'EXPERIMENTAL', 'label': 'extra-oral scanning of plaster model obtained via rubber base', 'interventionNames': ['Device: intra-oral digital scanner and extra-oral digital scanner']}, {'type': 'EXPERIMENTAL', 'label': 'extra-oral scanning of the rubber base impression', 'interventionNames': ['Device: intra-oral digital scanner and extra-oral digital scanner']}, {'type': 'EXPERIMENTAL', 'label': 'extra-oral scanning of the alginate impression', 'interventionNames': ['Device: intra-oral digital scanner and extra-oral digital scanner']}], 'interventions': [{'name': 'intra-oral digital scanner and extra-oral digital scanner', 'type': 'DEVICE', 'description': 'intra-oral and extra-oral digital scanners used to obtain digital models', 'armGroupLabels': ['Intra-oral scanning', 'extra-oral scanning of plaster model obtained via rubber base', 'extra-oral scanning of the alginate impression', 'extra-oral scanning of the plaster model obtained via alginate', 'extra-oral scanning of the rubber base impression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo Governorate', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed A Labib, DDS', 'role': 'CONTACT'}], 'facility': 'Faculty of Dentistry- Cairo University'}], 'centralContacts': [{'name': 'Mohamed A Labib, DDS', 'role': 'CONTACT', 'email': 'mohamedlabib90@hotmail.com', 'phone': '00201222144339'}], 'overallOfficials': [{'name': 'Khaled Hazem, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Intern Student', 'investigatorFullName': 'Moahmed Amr Labib', 'investigatorAffiliation': 'Cairo University'}}}}