Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04795258
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Health Assessment of Children in CP Class
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 671}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of decay on each tooth present in the mouth', 'timeFrame': '1 day', 'description': 'Presence of decay on each tooth present in the mouth'}, {'measure': 'Presence of care on each tooth present in the mouth', 'timeFrame': '1 day', 'description': 'Presence of care on each tooth present in the mouth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral hygiene', 'Public Health', 'Children', 'Prevention'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'first-grade student enrolled in a school in a zone REP/REP+', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Be a first-grade student enrolled in a school in a zone REP/REP+\n* Have a parental permission\n* Good understanding of the French language\n\nExclusion criteria:\n\n\\- lack of parental permission'}, 'identificationModule': {'nctId': 'NCT04795258', 'briefTitle': 'Oral Health Assessment of Children in CP Class', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault', 'orgStudyIdInfo': {'id': 'RECHMPL21_0116'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Camille INQUIMBERT, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}