Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-08 @ 12:16 AM
Study NCT ID:
NCT06990360
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2025-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2025-05-18', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mesiodistal (MD) Angle', 'timeFrame': '1 year', 'description': 'measures in the software in degrees'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Computer-guided implant placement', 'Edentulous mandible', '3D printed surgical guide'], 'conditions': ['Edentulous Alveolar Ridge', 'Edentulous Alveolar Ridge In Mandible']}, 'descriptionModule': {'briefSummary': 'Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. 8 implants were placed in each mandible virtually, 4 anterior implants and 4 posterior implants were placed. The plan was exported as STL file to be imported to the CAD software for designing of the stent. The surgical stent is printed using Micro DGP printer and invision tec e-shell 600 clear resin was used. Stainless steel sleeves were placed in the surgical guide then placed in ethanol 99% to remove the excess monomer.\n\nThe stent in placed over the mandible and sequential drilling was done until the desired osteotomies width was approached followed by the placement of the implants. Post-operative CBCT was done for the mandible including the implants to assess the accuracy, angulation and position of the placed implants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Five styrofoam mandibles', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Five styrofoam mandibles\n\nExclusion Criteria:\n\n* no fractures or pathology'}, 'identificationModule': {'nctId': 'NCT06990360', 'briefTitle': 'Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study', 'orgStudyIdInfo': {'id': 'FUE.REC (13)/12-2017'}, 'secondaryIdInfos': [{'id': 'Future University', 'type': 'OTHER', 'domain': 'Future University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CBCT Scanning', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Styrofoam mandibles were scanned using CBCT, which was performed for each mandible pre-operatively, the raw DICOM data set obtained from the CBCT scanning were imported to a special third-party software\\* for secondary reconstruction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '123456', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'future university in Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eslam Nashaat Saied Ahmed Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post graduate student', 'investigatorFullName': 'Eslam Nashaat Saied Ahmed Mohamed', 'investigatorAffiliation': 'Future University in Egypt'}}}}