Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-21 @ 1:35 AM
Study NCT ID:
NCT02754466
Status:
TERMINATED
Last Update Posted:
2021-10-01
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'whyStopped': 'Children could not be examined longer than 2 years due to COVID-19 pandemic and schools closure.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of the restorative procedure', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Success of the restorative treatment, not requiring any re-intervention (as endo or extraction). Success will be measured at different time frames.'}], 'secondaryOutcomes': [{'measure': 'Survival of the restoration', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'ART criteria for restoration survival will be used to assess survival of restoration (see Hilgert, 2014)'}, {'measure': 'Quality of life (and change in quality of life)', 'timeFrame': 'Baseline and 12months after intervention (change in quality of life)', 'description': 'Quality of life - Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) Questionnaires'}, {'measure': 'Treatment costs', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Initial and follow-up treatment costs to allow cost-effectiveness analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Dental Atraumatic Restorative Treatment', 'Oral Health']}, 'referencesModule': {'references': [{'pmid': '23543523', 'type': 'BACKGROUND', 'citation': 'Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003808. doi: 10.1002/14651858.CD003808.pub3.'}, {'pmid': '25132283', 'type': 'BACKGROUND', 'citation': 'Hilgert LA, de Amorim RG, Leal SC, Mulder J, Creugers NH, Frencken JE. Is high-viscosity glass-ionomer-cement a successor to amalgam for treating primary molars? Dent Mater. 2014 Oct;30(10):1172-8. doi: 10.1016/j.dental.2014.07.010. Epub 2014 Aug 15.'}, {'pmid': '26331379', 'type': 'BACKGROUND', 'citation': 'Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.'}, {'pmid': '26971353', 'type': 'BACKGROUND', 'citation': "Schwendicke F, Stangvaltaite L, Holmgren C, Maltz M, Finet M, Elhennawy K, Eriksen I, Kuzmiszyn TC, Kerosuo E, Domejean S. Dentists' attitudes and behaviour regarding deep carious lesion management: a multi-national survey. Clin Oral Investig. 2017 Jan;21(1):191-198. doi: 10.1007/s00784-016-1776-5. Epub 2016 Mar 12."}, {'pmid': '25511906', 'type': 'BACKGROUND', 'citation': 'Schwendicke F, Paris S, Stolpe M. Cost-effectiveness of caries excavations in different risk groups - a micro-simulation study. BMC Oral Health. 2014 Dec 15;14:153. doi: 10.1186/1472-6831-14-153.'}, {'pmid': '21524172', 'type': 'BACKGROUND', 'citation': 'De Menezes Abreu DM, Leal SC, Mulder J, Frencken JE. Dental anxiety in 6-7-year-old children treated in accordance with conventional restorative treatment, ART and ultra-conservative treatment protocols. Acta Odontol Scand. 2011 Nov;69(6):410-6. doi: 10.3109/00016357.2011.572561. Epub 2011 Apr 27.'}, {'pmid': '22824915', 'type': 'BACKGROUND', 'citation': 'Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clin Oral Investig. 2012 Oct;16(5):1337-46. doi: 10.1007/s00784-012-0783-4. Epub 2012 Jul 24.'}, {'pmid': '21384127', 'type': 'BACKGROUND', 'citation': 'de Amorim RG, Figueiredo MJ, Leal SC, Mulder J, Frencken JE. Caries experience in a child population in a deprived area of Brazil, using ICDAS II. Clin Oral Investig. 2012 Apr;16(2):513-20. doi: 10.1007/s00784-011-0528-9. Epub 2011 Mar 8.'}, {'pmid': '30552261', 'type': 'DERIVED', 'citation': 'Schwendicke F, Leal S, Schlattmann P, Paris S, Dias Ribeiro AP, Gomes Marques M, Hilgert LA. Selective carious tissue removal using subjective criteria or polymer bur: study protocol for a randomised controlled trial (SelecCT). BMJ Open. 2018 Dec 14;8(12):e022952. doi: 10.1136/bmjopen-2018-022952.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims evaluate the oral health conditions of schoolchildren and its relation to growth, development and well-being. Also, it seeks to evaluate different restorative interventions performed at school premises in primary teeth and its impact on the quality of life.', 'detailedDescription': "Schoolchildren, aged 6-8 years old, from the six public schools of a deprived suburban area of Brasília, Brazil will be recruited. In the stage 1 of the study, an epidemiological survey of the oral health status and an anthropometric evaluation of the children will be performed. Potential patient for study's stage 2 will be recruited. Quality of life surveys, patterns of oral hygiene and socio-demographic data will be collected.\n\nChildren with restorative treatment needs will be included in the study's stage 2. In this second stage, primary molars with deep dentin lesions will be treated according to two techniques for selective excavation of carious dentin: subjective criteria or using an objective criteria (polymer burs). For both groups restorations will be performed using a high-viscosity glass-ionomer. In shallow and medium depth dentin lesions, carious dentin will be excavated using hand instruments only (ART approach) and restored using two materials: a high-viscosity glass-ionomer or a combination of a self-etch adhesive and a bulk fill composite.\n\nAll children will be followed up (study's stage 3) to assess efficacy of the restorative interventions and impact of the restorative treatment on children's quality of life and development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 6-8 years old;\n* Good general health;\n* minimum one cavitated dentin carious lesion in a primary molar with sensible asymptomatic pulp.\n\nExclusion Criteria:\n\n* participating in other study;\n* plan to move or not residents;\n* systemic disease or general disability;\n* expected limited compliance; known allergy to study material; expected exfoliation of primary molars within 18 months.'}, 'identificationModule': {'nctId': 'NCT02754466', 'briefTitle': 'Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments', 'organization': {'class': 'OTHER', 'fullName': 'University of Brasilia'}, 'officialTitle': 'Oral Health and Its Relation to Growth, Development and Well-being of Schoolchildren Before and After Restorative Treatments', 'orgStudyIdInfo': {'id': '1.400.687/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep dentin lesions', 'description': 'Subjective vs objective criteria in selective excavation of carious lesions Group 1: selective carious dentin excavation using subjective criteria (standard protocol in Dentistry) Group 2: selective carious dentin excavation using objective criteria (polymer burs) All restorations performed using high-viscosity glass-ionomer.', 'interventionNames': ['Other: Subjective vs objective criteria in selective excavation']}, {'type': 'EXPERIMENTAL', 'label': 'Shallow and medium depth dentin lesion', 'description': 'Glass-ionomer vs Bulk fill composites in the ART approach All cavities excavated using hand-instruments only (ART approach) Group 1: restorations using high-viscosity glass-ionomer Group 2: restorations using self-etch adhesive and bulk fill composite', 'interventionNames': ['Other: Glass-ionomer vs Bulk fill composites in the ART approach']}], 'interventions': [{'name': 'Subjective vs objective criteria in selective excavation', 'type': 'OTHER', 'description': 'Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions', 'armGroupLabels': ['Deep dentin lesions']}, {'name': 'Glass-ionomer vs Bulk fill composites in the ART approach', 'type': 'OTHER', 'description': 'High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach', 'armGroupLabels': ['Shallow and medium depth dentin lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70910-900', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Escolas Públicas do Paranoá / Universidade de Brasília', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Leandro A Hilgert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Brasilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brasilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Operative Dentistry', 'investigatorFullName': 'Leandro Hilgert', 'investigatorAffiliation': 'University of Brasilia'}}}}