Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-26 @ 5:49 PM
Study NCT ID:
NCT01502566
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2011-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Intervention in Preventing Early Childhood Caries
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-19', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries status (dmfs)', 'timeFrame': 'after 12 months', 'description': 'Number of carious lesions, including intial lesions (white spot), per surface teeth. Also missed and filled surfaces due to caries will be included.'}], 'secondaryOutcomes': [{'measure': 'dental plaque index', 'timeFrame': 'after 12 months', 'description': 'The oral health status will be recorded by visible dental plaque index.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['educational intervention', 'dentals caries', 'population', 'new populational caries prevention strategies.'], 'conditions': ['Dental Caries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed?term=mohebbi%202009%20caries', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThe aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).\n\nMethods:\n\nThe trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Twenty-four public health centres (clusters) were randomly selected and assigned to intervention or control group (12 clusters per intervention group). In each center, up to 30 children/mothers were selected and invited to participate in the trial. Each mother was interviewed in order to collect socio-economic and demographic variables. The intervention group received by means of a pamphlet the oral health instructions, which were emphasized with verbal instructions. Dental examination will be carried out after 1 year for all teeth surfaces to determine caries status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with 0 to 12 months\n\nExclusion Criteria:\n\n* Children with teeth in mouth at the time of enrollment\n* Children not living in Pelotas\n* No sufficient information provided by the mother at the time of enrollment\n* Systemic diseases'}, 'identificationModule': {'nctId': 'NCT01502566', 'briefTitle': 'Educational Intervention in Preventing Early Childhood Caries', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Pelotas'}, 'officialTitle': 'A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries', 'orgStudyIdInfo': {'id': 'UFPEL-PPGO0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Intervention', 'description': 'Children/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries. This intervention will be applied at the Brazilian National Vaccination Day', 'interventionNames': ['Behavioral: Education Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will receive no intervention'}], 'interventions': [{'name': 'Education Intervention', 'type': 'BEHAVIORAL', 'description': 'Children/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries.', 'armGroupLabels': ['Educational Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96015560', 'city': 'Pelotas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Pelotas - School of Dentistry', 'geoPoint': {'lat': -31.76997, 'lon': -52.34101}}], 'overallOfficials': [{'name': 'Maximiliano S Cenci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Pelotas'}, {'name': 'Marina S Azevedo, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Pelotas'}, {'name': 'Ana R Romano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Pelotas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Pelotas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Associate Professor', 'investigatorFullName': 'Maximiliano Sergio Cenci', 'investigatorAffiliation': 'Federal University of Pelotas'}}}}