Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-25 @ 10:18 PM
Study NCT ID:
NCT03734094
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Custom-made Ceramic Barrier vs Titanium Mesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone height', 'timeFrame': '6 months', 'description': 'CBCT \\& Three dimensional planning software to measure the height of bone gained in millimeters.'}, {'measure': 'Bone width', 'timeFrame': '6 months', 'description': 'CBCT \\& Three dimensional planning software to measure the width of bone gained in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Histomorphometric - bone area percent', 'timeFrame': '6 months', 'description': 'Histomorphometric analysis of bone area percent'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss']}, 'descriptionModule': {'briefSummary': 'It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrophic posterior mandible\n* Both sexes\n* No intraoral soft and hard tissue pathology\n* No systemic condition that contraindicate implant placement\n\nExclusion Criteria:\n\n* Untreated gingivitis\n* Periodontitis\n* Insufficient oral hygiene\n* Previous radiation therapy\n* Head and neck neoplasia\n* Systemic disorders\n* Heavy smokers\n* Bone pathology\n* Psychiatric problems\n* Emotional instability\n* Unrealistic aesthetic demands'}, 'identificationModule': {'nctId': 'NCT03734094', 'briefTitle': 'Custom-made Ceramic Barrier vs Titanium Mesh', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible', 'orgStudyIdInfo': {'id': '737'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceramic Barrier', 'description': 'The use of a ceramic barrier to induce bone formation during GBR', 'interventionNames': ['Device: Titanium Mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Titanium mesh', 'description': 'The use of a titanium mesh to induce bone formation during GBR', 'interventionNames': ['Device: Ceramic barrier']}], 'interventions': [{'name': 'Ceramic barrier', 'type': 'DEVICE', 'description': 'The use of a ceramic barrier to induce bone formation during GBR', 'armGroupLabels': ['Titanium mesh']}, {'name': 'Titanium Mesh', 'type': 'DEVICE', 'description': 'The use of a titanium mesh to induce bone formation during GBR', 'armGroupLabels': ['Ceramic Barrier']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed El Saharty', 'investigatorAffiliation': 'Cairo University'}}}}