Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT03229018
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2017-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-07-23', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of linear measurement', 'timeFrame': '1 year', 'description': 'Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cone-Beam Computed Tomography']}, 'descriptionModule': {'briefSummary': 'study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes', 'detailedDescription': 'The real linear measurement will be measured in millimeter (mm) on the mandibles using digital caliper in the chosen areas.\n\nCBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the dimension in the chosen areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Selection of the human dry mandibles will be independent of age, gender and ethnicity.\n* They should be intact, free from any bone defects, fractures, pathology.\n* Dentate state of the mandibles is not an element in selection criteria; either dentulous or edentulous mandibles are acceptable\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03229018', 'briefTitle': 'Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study', 'orgStudyIdInfo': {'id': '1611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'voxel size', 'description': '200 μm and 300 μm Voxel Sizes', 'interventionNames': ['Diagnostic Test: Voxel size']}], 'interventions': [{'name': 'Voxel size', 'type': 'DIAGNOSTIC_TEST', 'description': '200 μm and 300 μm Voxel Sizes', 'armGroupLabels': ['voxel size']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Selim, BDs', 'role': 'CONTACT', 'email': 'Mohamed.selim@dentistry.cu.edu.eg', 'phone': '+201147703022'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student', 'investigatorFullName': 'Mohamed Ahmed Mohamed Selim', 'investigatorAffiliation': 'Cairo University'}}}}