Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-19 @ 5:32 AM
Study NCT ID:
NCT04244903
Status:
UNKNOWN
Last Update Posted:
2022-06-02
First Post:
2020-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of MLFA Types and MD in Egyptian Children With Erupted Canines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2020-01-25', 'studyFirstSubmitQcDate': '2020-01-25', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Midline diastema', 'timeFrame': '1 year', 'description': 'measuring diastema in millimeters using calibrated ruler'}], 'secondaryOutcomes': [{'measure': 'Frenal attachment types', 'timeFrame': '1 year', 'description': 'Direct visual method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midline diastema, Prevalence, Maxillary frenal types'], 'conditions': ['Destructive Attachment of Labial Frenum']}, 'descriptionModule': {'briefSummary': 'Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be conducted among Egyptian children with fully erupted canines, who regularly attend the outpatient clinic of pediatric dentistry department, Cairo University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy children\n* Egyptian children with fully erupted canines\n* Patient presented for routine evaluation or treatment\n\nExclusion Criteria:\n\n* Children who exhibited congenital anomalies or orofacial defects\n* Children with previous trauma in frenal area which affect its morphology\n* Children have previous surgical intervention in labial frenum or in the maxillary anterior region.\n* Children have any syndromes or habits that affect the anterior maxillary region.'}, 'identificationModule': {'nctId': 'NCT04244903', 'acronym': 'diastema', 'briefTitle': 'Prevalence of MLFA Types and MD in Egyptian Children With Erupted Canines', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Maxillary Labial Frenal Attachments Types and Midline Diastema in Egyptian Children With Fully Erupted Maxillary Permanent Canines', 'orgStudyIdInfo': {'id': 'CEBD-CU-2019-12-05'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Asmaa Saad, Master', 'role': 'CONTACT', 'email': 'asmaa_saad@dentistry.cu.edu.eg', 'phone': '01014007249'}], 'facility': 'Faculty of Dentistry Cairo University'}, {'city': 'Giza', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Egypt', 'facility': 'Asmaa Ahmed saad', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': '33,saad ibn aby waqas street, faisal, giza', 'role': 'CONTACT', 'email': 'Asmaa_saad@dentistry.cu.edu.eg', 'phone': '01014007249'}, {'name': '33,saad ibn aby waqas street, faisal, giza', 'role': 'CONTACT', 'email': 'Wael.mustafa@dentistry.cu.edu.eg', 'phone': '01004541979'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Asmaa Ahmed Saad', 'investigatorAffiliation': 'Cairo University'}}}}