Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-31 @ 1:10 AM
Study NCT ID:
NCT06753695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children
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': 825}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EAPD scoring criteria and wurzberg scroring system', 'timeFrame': '1 year', 'description': 'present/absent of the condition'}], 'secondaryOutcomes': [{'measure': 'VAS scale and SCASS scale', 'timeFrame': '1year', 'description': 'measuring dental hypersensitivity using VAS scale and SCASS scale to reach for an association of dental hypersensitivity and HSPM'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSPM', 'DH', 'hypo-mineralized second primary molars', 'hypomineralized E'], 'conditions': ['Hypomineralized Second Primary Molars', 'Dental Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children', 'detailedDescription': 'the prevalence of the condition of hypomineralized second primary molars in a group of Egyptian children and the association of this condition to dental hypersensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'a group of gentian children aged form4 to 9 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian children\n* cooperative patients both genders and included 4-9 years old children at least one HSPM affected molar and one non affected molar absence of syndromes or craniofacial anomalies\n\nExclusion Criteria:\n\n* other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent'}, 'identificationModule': {'nctId': 'NCT06753695', 'briefTitle': 'Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Hypomineralized Second Primary Molars(HSPM) and Its Association with Dental Hypersensitivity in a Group of Egyptian Children: a Cross-sectional Study.', 'orgStudyIdInfo': {'id': 'HSPM-DH-EG-2024'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya M Ibrahim, B.D.S.', 'role': 'CONTACT', 'email': 'aya.mamdouh@dentistry.edu.cu.eg', 'phone': '+2001003396390'}], 'overallOfficials': [{'name': 'Aya M Ibrahim, B.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cairo, Department of Dentistry.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be available within 12 months following publication of the primary results.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist and Principal Investigato', 'investigatorFullName': 'Aya Mamdouh Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}