[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229376":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":27,"centralContacts":31,"locations":32,"responsibleParty":45,"collaborators":31,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":31,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":31,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":31,"overallStatus":71,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1 - Recall Interval of 12 months","Oral clinical conditions:\n\nCaries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment",[12],"Procedure: Oral clinical conditions",{"label":14,"type":6,"description":10,"interventionNames":15},"Group 2 - Recall Interval of 18 months",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Oral clinical conditions","Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment",[9,14],[23,24,25,26],"Caries incidence","dental anxiety","oral health related quality of life","time and costs",[28],{"name":29,"affiliation":5,"role":30},"Marcelo Bönecker, Professor","STUDY_CHAIR",null,[33],{"facility":34,"status":31,"city":35,"state":31,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":31},"Dental School of University of São Paulo","São Paulo","05508-000","Brazil","BR",{"type":40,"coordinates":41},"Point",[42,43],-46.63611,-23.5475,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Gabriela Oliveira Berti","PhD student","100229376","impact-of-two-recall-intervals-on-dental-caries-incidence-anxiety-and-quality-of-life-of-preschool-children-100229376",false,"NCT02263768","Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children","Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial","Inclusion Criteria:\n\n* Children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo.\n* Guardians who have signed the informed consent confirming their participation and their child in research.\n\nExclusion Criteria:\n\n* Children showing visible dental plaque and gingivitis in baseline.\n* Children showing more than 08 active and\u002For inactive caries cavitated surfaces, and who show fistula and\u002For dental abscess.\n* Special patients.\n* Children who received professional application of fluoride in the 6 months prior to the survey.",true,"ALL","3 Years","5 Years",{"count":61,"type":62},224,"ACTUAL","INTERVENTIONAL",[65],"NA","Objectives: To assess the effectiveness of two recall intervals on dental caries incidence (primary outcome) in preschool children with low and moderate caries risk. The level of anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes) according to each interval will also be assessed. Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet on the recall of 12 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18 months.",[68,69,70],"Dental Caries","Quality of Life","Anxiety","COMPLETED","2019-04-17",{"date":74,"type":62},"2019-04-18",{"date":76,"type":62},"2015-03",{"date":78,"type":62},"2018-03",{"name":5,"class":6},1]