Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-03-14 @ 9:08 AM
Study NCT ID:
NCT06527950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Mandibular Region for Immediate Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Labial bone thickness', 'timeFrame': '1 year', 'description': 'Linear measurements on CBCT measured in mm'}], 'secondaryOutcomes': [{'measure': 'Lingual bone thickness', 'timeFrame': '1 year', 'description': 'Linear measurements on CBCT measured in mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'Immediate implant placement has been proven to be a successful treatment modality, it is however considered a technique sensitive procedure, which mandates careful planning on basis of the recommended guidelines and thorough site assessment. The anatomical characteristics play a major role in the treatment planning, to determine that enough alveolar bone housing is available to accommodate the implant in the correct prosthetic-driven position and to avoid complications that may be caused by injury of the adjacent anatomical structures. There is scarcity in the literature regarding data on the anatomical features of the mandibular anterior zone in relevance to immediate implant planning. Analysis of the anatomical landmarks of the mandibular anterior region to determine the thickness of the labial and lingual alveolar bony plates, in addition to the bony socket configuration along with the labio-lingual socket dimension and relate them to immediate implant treatment planning'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CBCTs of teeth including the mandibular anterior zone showing central and lateral incisors and canines. The area of interest should include the complete view of roots, alveolar and basal bone related to the centrals, laterals and canines', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CBCTs of teeth including the mandibular anterior zone showing central and lateral incisors and canines.\n\nExclusion Criteria:\n\n* Radiographs of patients with malaligned teeth or with current or previous orthodontic treatment.\n* Radiographs of patients with extensive bone loss due to infection or neoplasm in the area of interest'}, 'identificationModule': {'nctId': 'NCT06527950', 'briefTitle': 'Anterior Mandibular Region for Immediate Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Analysis of the Anatomical Aspects of the Anterior Mandibular Region for Immediate Implant Placement: an Observational Cone Beam Computed Tomography Study', 'orgStudyIdInfo': {'id': 'L123'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'observational study , no intervention'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Suzy Nabil Naiem, MSc', 'role': 'CONTACT', 'email': 'suzy.naiem@dentistry.cu.edu.eg', 'phone': '+201224785645'}, {'name': 'Hani El Nahass, Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Periodontist', 'investigatorFullName': 'Suzy Nabil Naiem', 'investigatorAffiliation': 'Cairo University'}}}}