Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 12:45 PM
Study NCT ID:
NCT06648135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labial Bone Thickness Around Immediate Implants in the Esthetic Zone Following a Novel Socket Evaluation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016025', 'term': 'Bone Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '5 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone labial to the implant', 'timeFrame': 'one year', 'description': 'measured at three levels 0, 2, and 5 mm below the labial bone crest after one year. Using fusion software.'}], 'secondaryOutcomes': [{'measure': 'Bone area at the Interproximal component', 'timeFrame': 'preoperative', 'description': 'Bone area at the mesial and distal Interproximal component in mm2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Implant Placement']}, 'descriptionModule': {'briefSummary': 'The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.', 'detailedDescription': 'Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immedaite implants in anterior maxilla\n* thick gingival phenotype\n* intact but thin labial plate of bone (≤1mm)\n* sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)\n\nExclusion Criteria:\n\n* smokers\n* pregnant women\n* patients with systemic disease\n* patients with parafunctional habits such as bruxism or clenching,\n* infected socket\n* periapical pathosis\n* history of radiotherapy or chemotherapy within the past 2 years.'}, 'identificationModule': {'nctId': 'NCT06648135', 'briefTitle': 'Labial Bone Thickness Around Immediate Implants in the Esthetic Zone Following a Novel Socket Evaluation System', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'a Novel Socket Evaluation System and Its Impact on Bone Formed Labial to Bone Immediate Anterior Implants. A 1-year Clinical Trial.', 'orgStudyIdInfo': {'id': 'IDCE 14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bone grafts', 'description': 'Immediate implant placed with bone grafts in the labial gap', 'interventionNames': ['Procedure: Immediate implants with bone grafts']}, {'label': 'No bone grafts', 'description': 'Immediate implant placed without bone grafts or any grafting substitutes in the labial gap', 'interventionNames': ['Procedure: Immediate implant placed without bone grafts or any grafting substitutes in the labial gap']}], 'interventions': [{'name': 'Immediate implants with bone grafts', 'type': 'PROCEDURE', 'description': 'Immediate implants with bone grafts', 'armGroupLabels': ['Bone grafts']}, {'name': 'Immediate implant placed without bone grafts or any grafting substitutes in the labial gap', 'type': 'PROCEDURE', 'description': 'Immediate implant placed without bone grafts or any grafting substitutes in the labial gap', 'armGroupLabels': ['No bone grafts']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed aboul fettouh, PhD', 'role': 'CONTACT', 'email': 'ahmedkey7@hotmail.com', 'phone': '+201019999983'}, {'name': 'Mariam Hanna, Mds', 'role': 'CONTACT', 'email': 'mariamsamy47@gmail.com', 'phone': '+201226536514'}, {'name': 'Ahmed Aboul fettouh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Dental Clinic Educational centre', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed I Aboul Fettouh, PhD', 'role': 'CONTACT', 'email': 'ahmed.abouelfotouh@miuegypt.edu.eg', 'phone': '+201019999983'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Exectutive and Clinical director of Implantology Master program, MIU', 'investigatorFullName': 'Ahmed Abo El Futtouh', 'investigatorAffiliation': 'Misr International University'}}}}