Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT05360693
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-04', 'studyFirstSubmitDate': '2022-04-30', 'studyFirstSubmitQcDate': '2022-04-30', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of bone labial to the implant', 'timeFrame': '1 year', 'description': 'CBCT superimposition (fusion scans)'}, {'measure': 'Horizontal labio-palatal bone width', 'timeFrame': '1 year', 'description': 'CBCT superimposition (fusion scans)'}, {'measure': 'horizontal labio-palatal bone collapse', 'timeFrame': '1 year', 'description': 'CBCT superimposition (fusion scans)'}, {'measure': 'vertical bone dimensional changes', 'timeFrame': '1 year', 'description': 'CBCT superimposition (fusion scans)'}], 'secondaryOutcomes': [{'measure': 'gingival index', 'timeFrame': '1 year', 'description': 'bleeding on probing around customized healing abutments placed on the immediate implants'}, {'measure': 'Implant failure', 'timeFrame': '1 year', 'description': "The following are the criteria of the implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can't reach any one of the success criteria."}, {'measure': 'Plaque Index', 'timeFrame': '1 year', 'description': 'Plaque index'}, {'measure': 'Postoperative Pain', 'timeFrame': '1 day, 3 days, 7 days', 'description': 'VAS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Implants', 'Esthetic Zone', 'Labial Bone Dimensional Changes', 'Without Labial Bone Grafting', 'With Labial Grafting', 'Thin Labial Plate of Bone Pre-extraction']}, 'descriptionModule': {'briefSummary': 'For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with \\& without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria:\n\n1. adult (\\>20 years) with non-restorable maxillary teeth in the esthetic zone,\n2. thick gingival phenotype,\n3. intact but thin labial plate of bone (≤1mm)\n4. intact palatal bone extending at least 6mm apically,\n5. sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)\n6. labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.\n7. patients agreed to sign a written informed consent.\n\nExclusion criteria:\n\n1. smokers,\n2. pregnant women,\n3. patients with systemic disease,\n4. patients with parafunctional habits such as bruxism or clenching,\n5. infected socket,\n6. periapical pathosis\n7. history of radiotherapy or chemotherapy within the past 2 years.'}, 'identificationModule': {'nctId': 'NCT05360693', 'briefTitle': 'Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'IDCE.N1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate implant placement without bone grafting', 'description': "After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface.", 'interventionNames': ['Procedure: immediate implant placement without bone grafting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'immediate implant placement with bone grafting', 'description': "After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface.", 'interventionNames': ['Procedure: immediate implant placement with socket bone grafting']}], 'interventions': [{'name': 'immediate implant placement without bone grafting', 'type': 'PROCEDURE', 'description': 'After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done \\& patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.', 'armGroupLabels': ['immediate implant placement without bone grafting']}, {'name': 'immediate implant placement with socket bone grafting', 'type': 'PROCEDURE', 'description': 'After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.', 'armGroupLabels': ['immediate implant placement with bone grafting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'state': 'Maadi', 'country': 'Egypt', 'facility': 'International Dental Continuing Education', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '35855', 'city': 'Cairo', 'state': 'Manial', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Noha A Ghallab, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Oral Medicine & Periodontology'}, {'name': 'Ahmed I Abou- El-Fettouh, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Misr International University'}, {'name': 'Abdelrahman Zohny, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}, {'name': 'Nael M Adel, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}, {'name': 'Khaled Abdelghaffar, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Periodontology, Ain Shams University'}, {'name': 'Mariam S Abdelmalak, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}, {'name': 'Nesma M Shemais, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Oral Medicine & Periodontology, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in the department of Oral Medicine & Periodontology', 'investigatorFullName': 'Nesma Mohamed Fouad Shemais', 'investigatorAffiliation': 'Cairo University'}}}}