Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
Study NCT ID:
NCT04127357
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2019-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536528', 'term': 'Van der Woude syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035124', 'term': 'CMW cement'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Direct cost estimate', 'timeFrame': '6 months', 'description': 'To estimate costs, the sessions were timed (initial and reevaluations) and for each consultation a table was filled in, which should contain the quantities of materials used per session. Prices of materials were considered by inferring the market value obtained by an average of 3 (three) different places that market the products in question, thus obtaining different costs for the proposed treatments.'}, {'measure': 'Direct cost estimate', 'timeFrame': '12 months', 'description': 'To estimate costs, the sessions were timed (initial and reevaluations) and for each consultation a table was filled in, which should contain the quantities of materials used per session. Prices of materials were considered by inferring the market value obtained by an average of 3 (three) different places that market the products in question, thus obtaining different costs for the proposed treatments.'}], 'primaryOutcomes': [{'measure': 'Clinical evaluation of caries progression', 'timeFrame': '6 months', 'description': 'With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.'}, {'measure': 'Clinical evaluation of caries progression', 'timeFrame': '12 months', 'description': 'With the radiographs in hand, the possible progression of the treated caries lesion was observed, which was coded as: a) Absent progression: no radiolucent area of the lesion; b) Present progression: with increase in the radiolucent area of the lesion.'}], 'secondaryOutcomes': [{'measure': 'Sealant retention', 'timeFrame': '6 months', 'description': 'Clinical evaluation of sealant retention was performed using the criteria used by Pardi: RT- total retention, PP1- presence of sealant on two thirds of the occlusal surface, PP2- presence of sealant on one third of the occlusal surface. PT-total loss of sealant on occlusal surface.'}, {'measure': 'Sealant retention', 'timeFrame': '12 months', 'description': 'Clinical evaluation of sealant retention was performed using the criteria used by Pardi: RT- total retention, PP1- presence of sealant on two thirds of the occlusal surface, PP2- presence of sealant on one third of the occlusal surface. PT-total loss of sealant on occlusal surface.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pit and fissure sealants', 'Pediatric dentistry', 'Toothbrushing'], 'conditions': ['Dental Caries in Children', 'Pit and Fissure Sealant', 'Toothbrushing']}, 'referencesModule': {'references': [{'pmid': '27689929', 'type': 'RESULT', 'citation': 'Meyer-Lueckel H, Paris S. When and How to Intervene in the Caries Process. Oper Dent. 2016 Sep;41(S7):S35-S47. doi: 10.2341/15-022-O.'}, {'pmid': '21479565', 'type': 'RESULT', 'citation': 'Bakhshandeh A, Qvist V, Ekstrand KR. Sealing occlusal caries lesions in adults referred for restorative treatment: 2-3 years of follow-up. Clin Oral Investig. 2012 Apr;16(2):521-9. doi: 10.1007/s00784-011-0549-4. Epub 2011 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To verify the progression of active microcavitated carious lesions on occlusal surfaces of primary molars after the orientation of the brushing technique associated with fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial. Methodology: We selected 22 children from 4 to 9 years old from the public school system of the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS). Randomization was performed en bloc and stratified by two conditions (age and caries experience). The selected teeth were divided into two groups: the first (G1) was submitted to brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing technique, whose application of the material was performed under absolute or relative isolation, selected through a second randomization. The molars undergoing treatment were evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type of treatment, dental group and sealant retention by the Chi-square test. For cost analysis, the variance test (ANOVA) was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one primary molar with active caries lesions classified as ICDAS score 3.\n\nExclusion Criteria:\n\n* Children with differentiated management needs and/or systemic diseases with oral involvement.\n* Primary molar with active caries lesions classified as ICDAS score 3 that had other caries lesions involving dentin, restorations, sealants, or other types of formation defects.'}, 'identificationModule': {'nctId': 'NCT04127357', 'briefTitle': 'Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces', 'organization': {'class': 'OTHER', 'fullName': 'Faculty Sao Leopoldo Mandic Campinas'}, 'officialTitle': 'Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial', 'orgStudyIdInfo': {'id': 'SLM 8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A - Control', 'description': 'Brushing with 1450 ppm fluoride toothpaste.', 'interventionNames': ['Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).']}, {'type': 'EXPERIMENTAL', 'label': 'B - Test', 'description': 'Resin sealing (FluroShield, Dentsply, Brazil).', 'interventionNames': ['Procedure: 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).']}], 'interventions': [{'name': '1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).', 'type': 'PROCEDURE', 'description': "After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil).\n\nThe teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months.", 'armGroupLabels': ['A - Control', 'B - Test']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose Carlos P Imparato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sao Leopoldo Mandic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty Sao Leopoldo Mandic Campinas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Senior Lecturer, Clinical Professor', 'investigatorFullName': 'Jose Carlos P Imparato', 'investigatorAffiliation': 'Faculty Sao Leopoldo Mandic Campinas'}}}}