Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 7:15 AM
Study NCT ID:
NCT05620459
Status:
UNKNOWN
Last Update Posted:
2022-11-17
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Maxilla Augmentation Using Chin Bone Ring With Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-12', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-12', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone quantity (crestal bone) height)', 'timeFrame': '3 months after operation day', 'description': 'Cone beam'}], 'secondaryOutcomes': [{'measure': 'Bone quality (bone density at the ring alveolus interface)', 'timeFrame': '3 months after operation day', 'description': 'In Hounsfield units making use of ROI region of intrest tool included in the software'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ridge Augmentation']}, 'referencesModule': {'references': [{'pmid': '31293264', 'type': 'BACKGROUND', 'citation': 'Yuce MO, Adali E, Turk G, Isik G, Gunbay T. Three-dimensional bone grafting in dental implantology using autogenous bone ring transplant: Clinical outcomes of a one-stage technique. Niger J Clin Pract. 2019 Jul;22(7):977-981. doi: 10.4103/njcp.njcp_652_18.'}, {'pmid': '26644216', 'type': 'BACKGROUND', 'citation': 'Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.'}, {'pmid': '31513341', 'type': 'BACKGROUND', 'citation': 'Simpson KT, Bryington M, Agusto M, Harper M, Salman A, Schincaglia GP. Computer-Guided Surgery Using Human Allogenic Bone Ring With Simultaneous Implant Placement: A Case Report. Clin Adv Periodontics. 2020 Mar;10(1):16-22. doi: 10.1002/cap.10073. Epub 2019 Oct 14.'}, {'pmid': '20218871', 'type': 'BACKGROUND', 'citation': 'Stevens MR, Emam HA, Alaily ME, Sharawy M. Implant bone rings. One-stage three-dimensional bone transplant technique: a case report. J Oral Implantol. 2010;36(1):69-74. doi: 10.1563/AAID-JOI-D-09-00029.'}]}, 'descriptionModule': {'briefSummary': 'The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).', 'detailedDescription': "* Chin bone ring will be harvested from patient's(10 in number) chin to augment the recent extraction socket with buccal bone defect, followed by implant placement.\n* The process of harvesting and placement of ring will be computer guided which adds lots of accuracy to the bone ring required size from the donor site and the proper placement of both the ring and the implant at the recipient site"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.\n* Patients who have given their consent for this trial.\n* Both genders males and females will be included.\n\nExclusion Criteria:\n\n* • Untreated periodontitis.\n\n * Poor oral hygiene and motivation.\n * Uncontrolled diabetes.\n * Pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT05620459', 'briefTitle': 'Anterior Maxilla Augmentation Using Chin Bone Ring With Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Computer Guided Simultaneous Implant Placement With Ridge Augmentation Using Autogenous Bone Ring Transplant in Defective Maxillary Anterior Sockets', 'orgStudyIdInfo': {'id': '10722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm (Ridge augmentation with simultaneous implant placement)', 'description': 'Chin bone ring is harvested using surgical guide to augment\n\n1. anterior maxillary defective recent extraction sockets OR\n2. remaining roots that need extraction and are accompanied with labial bone loss Associated with simultaneous implant placement with the aid of surgical guides', 'interventionNames': ['Procedure: Ridge augmentation using chin bone ring with simultaneous implant placement']}], 'interventions': [{'name': 'Ridge augmentation using chin bone ring with simultaneous implant placement', 'type': 'PROCEDURE', 'description': 'surgical guides are to be used to harvest chin bone ring, the rings are to be used for bone augmentation in extraction sockets (salama and salama classsification type II),simultaneously implant placement.', 'armGroupLabels': ['Interventional arm (Ridge augmentation with simultaneous implant placement)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'cairo/Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'cairo university', 'role': 'CONTACT'}], 'facility': 'cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mostafa M gad, BDS', 'role': 'CONTACT', 'email': 'mostafa.gad@dentistry.cu.edu.eg', 'phone': '201000264683'}], 'overallOfficials': [{'name': 'Mostafa M gad, bds', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator (Master of science student oral and maxillofacial surgery)', 'investigatorFullName': 'Mostafa Mohamed Gad Mohamed Gad', 'investigatorAffiliation': 'Cairo University'}}}}