Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-27 @ 4:56 AM
Study NCT ID:
NCT02789202
Status:
UNKNOWN
Last Update Posted:
2018-03-21
First Post:
2016-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
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': 'C024633', 'term': 'silver diamine fluoride'}, {'id': 'D012969', 'term': 'Sodium Fluoride'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Direct and Indirect Costs of initial procedures and consequent interventions during 24 months', 'timeFrame': '24 months'}], 'primaryOutcomes': [{'measure': 'Number of caries lesions which progressed to dentine', 'timeFrame': '24 months', 'description': 'Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)'}], 'secondaryOutcomes': [{'measure': 'Parental acceptability to the treatment using a VAS scale', 'timeFrame': '12 months', 'description': 'Parents will be asked to report their satisfaction with the treatment using a VAS scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dental caries', 'deciduous tooth'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies 1 to 3 years;\n* Babies with initial dental caries lesion.\n\nExclusion Criteria:\n\n* Parents who do not consent.'}, 'identificationModule': {'nctId': 'NCT02789202', 'briefTitle': "Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces", 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': "Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces", 'orgStudyIdInfo': {'id': 'SDFtrials-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silver Diamine Fluoride', 'description': 'Control treatment', 'interventionNames': ['Other: Silver diamine fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride Varnish', 'description': 'Test treatment', 'interventionNames': ['Other: Fluoride Varnish']}], 'interventions': [{'name': 'Silver diamine fluoride', 'type': 'OTHER', 'otherNames': ['SDF'], 'description': 'Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.', 'armGroupLabels': ['Silver Diamine Fluoride']}, {'name': 'Fluoride Varnish', 'type': 'OTHER', 'otherNames': ['sodium fluoride'], 'description': 'Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish', 'armGroupLabels': ['Fluoride Varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mariana Minatel Braga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Associate professor', 'investigatorFullName': 'Mariana Minatel Braga', 'investigatorAffiliation': 'University of Sao Paulo'}}}}