Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 5:37 AM
Study NCT ID:
NCT04567966
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Bone Plate Versus Cortico-cancellous Block Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of bone quality', 'timeFrame': '4 months', 'description': "Histomorphometric analysis (Masson's Trichrome stain)"}], 'secondaryOutcomes': [{'measure': 'Horizontal ridge dimensional changes', 'timeFrame': '4 months', 'description': 'Measuring the linear horizontal changes using CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Split-bone block technique', 'Cortical bone plate', 'Cortico-cancellous block graft'], 'conditions': ['Horizontal Atrophy of Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': 'Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients aged 18 years or older with partial edentulism of the mandible\n* The residual ridge width must be 4 mm or less\n* Intra-oral donor sites should be available in the external oblique ridge and symphyseal area\n\nExclusion Criteria:\n\n* Patients with general contraindications for implant surgery such as uncontrolled diabetes\n* Irradiation of the head and neck region\n* Intravenous bisphosphonate\n* Pregnancy\n* Smokers, alcoholics and drug abusers'}, 'identificationModule': {'nctId': 'NCT04567966', 'briefTitle': 'Cortical Bone Plate Versus Cortico-cancellous Block Graft', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study', 'orgStudyIdInfo': {'id': 'PER 18-1D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cortical bone plate', 'description': 'A cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge.', 'interventionNames': ['Procedure: Split-block technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cortico-cancellous block graft', 'description': 'A cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge.', 'interventionNames': ['Procedure: Cortico-cancellous block graft']}], 'interventions': [{'name': 'Split-block technique', 'type': 'PROCEDURE', 'description': 'Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.', 'armGroupLabels': ['Cortical bone plate']}, {'name': 'Cortico-cancellous block graft', 'type': 'PROCEDURE', 'description': 'Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.', 'armGroupLabels': ['Cortico-cancellous block graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abbassia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Researcher', 'investigatorFullName': 'Mina Adel Rizk Botros', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}