Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT04747028
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Malnutrition on Primary and Permanent Dentation
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries index', 'timeFrame': '1month', 'description': 'Score obtained from DMF index'}], 'secondaryOutcomes': [{'measure': 'E amel malformation', 'timeFrame': '1month', 'description': 'Modified DDE index'}]}, 'conditionsModule': {'conditions': ['Study Focus on the Effect of Malnutrition and Dental Problem']}, 'descriptionModule': {'briefSummary': 'The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants', 'detailedDescription': 'The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescent diagnosed with malnutrition in the past or presnt time.patient should not suffer from any other systemic disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parent accept to sign the informed consent Participants not suffering from any other systematic disease\n\nExclusion Criteria:\n\n* non coopreative patient Suffering from systematic disease'}, 'identificationModule': {'nctId': 'NCT04747028', 'briefTitle': 'Effect of Malnutrition on Primary and Permanent Dentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Malnutrition on Primary and Permanent Dentition a Cross Sectional Study', 'orgStudyIdInfo': {'id': '66789'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary dentition', 'description': 'Children from 4 to 6 years old suffering from malnutrition', 'interventionNames': ['Diagnostic Test: Dmf score']}, {'label': 'Age 13 to 16', 'description': 'Adolecentsfrom 13 to 16 suffering from malnutrition at present time or during their childhood', 'interventionNames': ['Diagnostic Test: Dmf score']}], 'interventions': [{'name': 'Dmf score', 'type': 'DIAGNOSTIC_TEST', 'description': 'A chart to calculate the caries index', 'armGroupLabels': ['Age 13 to 16', 'Primary dentition']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at conservative department', 'investigatorFullName': 'Dina mounir elkady', 'investigatorAffiliation': 'Cairo University'}}}}