Viewing Study NCT06229561


Ignite Creation Date: 2025-12-24 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
Study NCT ID: NCT06229561
Status: COMPLETED
Last Update Posted: 2024-01-29
First Post: 2023-12-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2023-12-29', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Buccal bone thickness', 'timeFrame': '6 months follow up', 'description': 'Assess the buccal bone thickness before and after the graft application'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Comparative Study']}, 'referencesModule': {'references': [{'pmid': '37279214', 'type': 'RESULT', 'citation': 'Elaskary A, Abdelrahman H, Elfahl B, Elsabagh H, El-Kimary G, Ghallab NA. Immediate Implant Placement in Intact Fresh Extraction Sockets Using Vestibular Socket Therapy Versus Partial Extraction Therapy in the Esthetic Zone: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2023 May, Jun;38(3):468-478. doi: 10.11607/jomi.9973.'}]}, 'descriptionModule': {'briefSummary': 'Comparative study between 2 groups to assess the feasibility of using Acellular dermal matrix vs Soft tissue Graft after immediate implant placement', 'detailedDescription': 'It was conclude that SCTG is the gold standard for soft tissue augmentation up till now, However ADM can be alternative to autogenous soft tissue graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMedically free\n\nExclusion Criteria:\n\nHeavy smoking'}, 'identificationModule': {'nctId': 'NCT06229561', 'briefTitle': 'Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of Bone After Immediate Implant Placement', 'orgStudyIdInfo': {'id': 'Nmohamed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADM and SCTG', 'description': 'ADM and SCTG', 'interventionNames': ['Combination Product: Acellular Dermal Matrix']}, {'type': 'EXPERIMENTAL', 'label': 'Acellular Dermal Matrix and soft tissue graft', 'description': '12participatent in two groups', 'interventionNames': ['Combination Product: Acellular Dermal Matrix']}], 'interventions': [{'name': 'Acellular Dermal Matrix', 'type': 'COMBINATION_PRODUCT', 'description': 'Feasibility of soft tissue graft after immediate implant placement', 'armGroupLabels': ['ADM and SCTG', 'Acellular Dermal Matrix and soft tissue graft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nāşir', 'country': 'Egypt', 'facility': 'Azhar University', 'geoPoint': {'lat': 24.54246, 'lon': 33.03449}}], 'overallOfficials': [{'name': 'Azhar Journal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'No affliction'}]}, 'ipdSharingStatementModule': {'url': 'http://www2.cloud.editorialmanager.com/azjd/default2.aspx', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months follow up', 'ipdSharing': 'YES', 'description': 'Soft tissue graft versus acellular dermal matrix in preservation of buccal plate of bone after immediate implant placement', 'accessCriteria': 'https://www2.cloud.editorialmanager.com/azjd/default2.aspx'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investor', 'investigatorFullName': 'Nehal Mohamed Ibrahim Abbas', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}