Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-22 @ 12:25 PM
Study NCT ID:
NCT03016793
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Cleft Grafting Using Two Different Alloplastic Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C033607', 'term': 'puerarin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esthetic satisfaction', 'timeFrame': '6 months', 'description': 'outcome measured by numerical scale from 1-10'}], 'secondaryOutcomes': [{'measure': 'bone volume', 'timeFrame': '6 months', 'description': 'outcome measured by cone beam computed tomography ( CBCT)'}, {'measure': 'bone density', 'timeFrame': '6 months', 'description': 'Outcome measured by cone beam computed tomography (CBCT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alveolar Cleft Grafting']}, 'descriptionModule': {'briefSummary': 'P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10\n\nRadiographic outcome:\n\nOutcome name Measurment Device Measurment unite Bone volume\n\n(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density\n\n(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with unilateral alveolar cleft indicated for bone grafting.\n2. Patients age range between 8-12years.\n\nExclusion Criteria:\n\n1. Patients with any systemic diseases that can affect normal bone and/or wound healing.\n2. Patients with bilateral alveolar clefts.'}, 'identificationModule': {'nctId': 'NCT03016793', 'briefTitle': 'Alveolar Cleft Grafting Using Two Different Alloplastic Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Pura-28568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'puerarin and β- tricalcium phosphate', 'description': 'purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.\n\nβ- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing', 'interventionNames': ['Drug: Puerarin', 'Drug: β- tricalcium phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'β- tricalcium phosphate alone', 'description': 'β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing', 'interventionNames': ['Drug: β- tricalcium phosphate alone']}], 'interventions': [{'name': 'Puerarin', 'type': 'DRUG', 'otherNames': ['purabone'], 'description': 'purabone (puerarin) is a bone graft used for surgical repair of bony defects.', 'armGroupLabels': ['puerarin and β- tricalcium phosphate']}, {'name': 'β- tricalcium phosphate', 'type': 'DRUG', 'description': 'β- tricalcium phosphate is a bone graft used for surgical repair of bony defects', 'armGroupLabels': ['puerarin and β- tricalcium phosphate']}, {'name': 'β- tricalcium phosphate alone', 'type': 'DRUG', 'otherNames': ['β- tricalcium phosphate'], 'description': 'β- tricalcium phosphate is a bone graft used for surgical repair of bony defects', 'armGroupLabels': ['β- tricalcium phosphate alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suez', 'country': 'Egypt', 'contacts': [{'name': 'Mohamd H Maklad, BSC', 'role': 'CONTACT', 'email': 'dentomaklad@yahoo.com', 'phone': '+201002648553'}], 'facility': 'Mohamad hamed Maklad', 'geoPoint': {'lat': 29.97371, 'lon': 32.52627}}], 'centralContacts': [{'name': 'Mohamed H Maklad, BSC', 'role': 'CONTACT', 'email': 'dentomaklad@yahoo.com', 'phone': '+201002648553'}], 'overallOfficials': [{'name': 'Samar Swelam, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of oral and dental medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamad Hamed Maklad', 'investigatorAffiliation': 'Cairo University'}}}}