[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506490":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"conventional restoration group (control)","ACTIVE_COMPARATOR","The teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).",[13],"Procedure: Restoration with conventional resin composite",{"label":15,"type":16,"description":17,"interventionNames":18},"polyvinyl crown - experimental group","EXPERIMENTAL","The teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).",[19],"Combination Product: Restoration with resin composite and polyvinyl crown",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Restoration with resin composite and polyvinyl crown","Restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Restoration with conventional resin composite","Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Thais Gimenez","CONTACT","+5511989456585","thais.gimenez@alumni.usp.br",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sandra Kalil Bussadori","Principal Investigator","100506490","phase-3-aesthetic-restorations-in-deciduous-anterior-teeth-100506490",false,"NCT05875064","Aesthetic Restorations in Deciduous Anterior Teeth","Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial","Inclusion Criteria:\n\n* Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.\n\nExclusion Criteria:\n\n* Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2\u002F3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and\u002For deep bite.","ALL","12 Months","60 Months",{"count":53,"type":54},194,"ESTIMATED","INTERVENTIONAL",[57],"PHASE3","This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.",[60],"Dental Caries in Children","NOT_YET_RECRUITING","2024-11-20",{"date":64,"type":65},"2024-11-22","ACTUAL",{"date":67,"type":54},"2025-01-26",{"date":69,"type":54},"2026-11-30",{"name":5,"class":6}]