Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT03389594
Status:
UNKNOWN
Last Update Posted:
2018-01-03
First Post:
2017-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each patient will be given a code by researcher (M.H) and the observers will be blind to which group this case belong'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angular deviation', 'timeFrame': 'Immediate post operative', 'description': 'Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm)'}, {'measure': 'Linear deviation', 'timeFrame': 'Immediate post operative', 'description': 'Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical guide', 'Computer guided implantology', 'CBCT voxel size'], 'conditions': ['Accuracy of Surgical Guide in Implants']}, 'descriptionModule': {'briefSummary': 'Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.\n\nThe study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .', 'detailedDescription': 'Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.\n\nThe study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm \\& 0.2mm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* partially edentulous patients seeking for dental implant\n* Bucco-lingual width more than 6 mm\n* Medically free patients\n\nExclusion Criteria:\n\n* patients with thin ridges that may need augmentation\n* patients with systematic diseases that may affect bone quality\n* completely edentulous patients\n* patients with limited mouth opening'}, 'identificationModule': {'nctId': 'NCT03389594', 'briefTitle': 'Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ElhagCUImplant'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Surgical guide designed from voxel size 0.2mm', 'description': 'Surgical guide will be designed based on CBCT voxel size 0.2mm'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical guide designed from voxel size 0.4m', 'description': 'Surgical guide will be designed based on CBCT voxel size 0.4 mm', 'interventionNames': ['Other: Surgical guide']}], 'interventions': [{'name': 'Surgical guide', 'type': 'OTHER', 'description': 'Surgical Guide for this group will designed from 0.4mm voxel size', 'armGroupLabels': ['Surgical guide designed from voxel size 0.4m']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Info@dentistry.cu.edu.eg', 'role': 'CONTACT', 'email': 'Info@dentistry.cu.edu.eg', 'phone': '0223634965'}, {'name': 'Mohammed Elhag', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Elhag, Bachelorie', 'role': 'CONTACT', 'email': 'dentmail@dentistry.cu.edu.eg', 'phone': '(+202) 23634965', 'phoneExt': '202'}], 'overallOfficials': [{'name': 'Cairo university', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University, Faculty of dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohammed Mohammed Ahmed Elhag', 'investigatorAffiliation': 'Cairo University'}}}}