Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-09 @ 9:15 AM
Study NCT ID:
NCT03005405
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars
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': 'D005899', 'term': 'Glass Ionomer Cements'}], 'ancestors': [{'id': 'D003738', 'term': 'Dental Cements'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'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': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of reintervention', 'timeFrame': '24 months', 'description': 'Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline.\n\nAfter cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.'}], 'secondaryOutcomes': [{'measure': "Child's reported discomfort", 'timeFrame': '1st day', 'description': 'The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale'}, {'measure': 'Duration of treatments', 'timeFrame': '1st day', 'description': 'Time spent in interventions will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dental Caries', 'Primary tooth', 'Ionomer Sealants', 'Glass Ionomer Restoration'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.', 'detailedDescription': "This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThey will be included in this study children:\n\n* aged 3 years and 6 years and 11 months;\n* With complete primary dentition;\n* Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.\n* Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.\n\nExclusion Criteria:\n\n* who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;\n* who are involved in other research that may impact on this study;\n* whose parents that not agree in participate.'}, 'identificationModule': {'nctId': 'NCT03005405', 'briefTitle': 'Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SEALANT-CARDEC02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'restoration - control', 'description': 'Restoration', 'interventionNames': ['Procedure: Ionomer Restoration (control)', 'Procedure: Oral hygiene orientation and professional fluoride application']}, {'type': 'EXPERIMENTAL', 'label': 'sealant - test', 'description': 'Sealant', 'interventionNames': ['Procedure: Ionomer Sealant (test)', 'Procedure: Oral hygiene orientation and professional fluoride application']}], 'interventions': [{'name': 'Ionomer Restoration (control)', 'type': 'PROCEDURE', 'otherNames': ['glass ionomer cement, restoration'], 'description': 'Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements', 'armGroupLabels': ['restoration - control']}, {'name': 'Ionomer Sealant (test)', 'type': 'PROCEDURE', 'otherNames': ['glass ionomer cement, sealant'], 'description': 'Sealing of moderate caries lesions without any caries removal or cavity opening.', 'armGroupLabels': ['sealant - test']}, {'name': 'Oral hygiene orientation and professional fluoride application', 'type': 'PROCEDURE', 'description': 'Oral hygiene orientation and professional fluoride application', 'armGroupLabels': ['restoration - control', 'sealant - test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mariana M Braga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Publication of all results, accessibility to data if necessary'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Associate Professor', 'investigatorFullName': 'Mariana Minatel Braga', 'investigatorAffiliation': 'University of Sao Paulo'}}}}