Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT03719235
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-10', 'size': 364738, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-22T16:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of diagnostic accuracy of linear measurements', 'timeFrame': 'within 2 years', 'description': 'measurements made on dry mandibles will be compared with measurements obtained from CBCT scans \\& digital panoramic radiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cone Beam Computed Tomography']}, 'descriptionModule': {'briefSummary': 'measurements performed directly on dry mandibles will be compared with measurements obtained from CBCT( ultra-low dose) scans and Digital panoramic radiography.', 'detailedDescription': 'Mandibular anaesthetic landmarks will be identified on each dry mandible and will be marked using gutta percha.\n\nThe ten human dry mandibles will be submitted for:\n\n1. Digital Panoramic Radiography. Panoramic radiographs will be obtained using the SOREDEX CRANEX™ 3Dx unit. The exposure parameters will be 8Ma, 63kVp and 16.4 sec exposure time.\n2. Cone Beam Computed Tomography (CBCT). SOREDEX CRANEX™ 3Dx unit will be used in this study. Images will be acquired at a single rotation. SOREDEX® MiniDose parameters will be used. The exposure parameters will be 3.2 Ma, 90kVp and 2.3 sec exposure time to take the advantage of 3D data in dose sensitive cases like children, or reduce the radiation dose for the patient.\n\nThe real linear measurements will be measured in millimeter on dry mandibles using digital caliper and will be compared with measurements obtained from both techniques.\n\nImages will be evaluated by two experienced radiologists of ten years of experience. Each one will evaluate the images separately twice with a period of two weeks in-between the two reading sessions. The researcher will measure out the real linear measurements on the dry mandibles using digital caliper.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 10 to 70 years\n* no gender nor race predilection\n* Either dentulous or edentulous are acceptable.\n\nExclusion Criteria:\n\n* fractures\n* pathology'}, 'identificationModule': {'nctId': 'NCT03719235', 'acronym': 'CBCT', 'briefTitle': 'Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography Performed on Mandibular Anaesthetic Landmarks Versus Real Mandibular Measurements', 'orgStudyIdInfo': {'id': 'HWEF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'column', 'description': 'ultra-low dose CBCT versus digital panoramic radsiography', 'interventionNames': ['Other: CBCT']}], 'interventions': [{'name': 'CBCT', 'type': 'OTHER', 'description': 'ultra-low dose CBCT', 'armGroupLabels': ['column']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12411', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hala wk elfayoumy', 'role': 'CONTACT', 'email': 'halaelfayoumy@hotmail.com', 'phone': '01112222565'}, {'name': 'mohamed md el sawy', 'role': 'CONTACT', 'email': 'mohamed.mourad@yahoo.com', 'phone': '01005001650'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'hala wk el fayoumy', 'role': 'CONTACT', 'email': 'halaelfayoumy@hotmail.com', 'phone': '01112222565', 'phoneExt': 'cairo'}, {'name': 'mohamed md el sawy', 'role': 'CONTACT', 'email': 'mohamed.mourad@yahoo.com', 'phone': '01005001650', 'phoneExt': 'cairo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hala Wafik Mohamed El Fayoumy', 'investigatorAffiliation': 'Cairo University'}}}}