[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634399":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":43,"locations":43,"responsibleParty":44,"collaborators":43,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":43,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":43,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":43,"overallStatus":67,"whyStopped":43,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanical Prophylaxis (Control)","ACTIVE_COMPARATOR","Participants will receive mechanical prophylaxis using a Robinson brush at low speed with water, without the use of photosensitizers or blue LED irradiation.",[13],"Procedure: Mechanical Prophylaxis",{"label":15,"type":16,"description":17,"interventionNames":18},"aPDT with Erythrosine","EXPERIMENTAL","Participants will receive antimicrobial photodynamic therapy (aPDT) using erythrosine as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection.",[19],"Procedure: aPDT with Erythrosine",{"label":21,"type":16,"description":22,"interventionNames":23},"aPDT with GC TriPlaque ID Gel","Participants will receive antimicrobial photodynamic therapy (aPDT) using GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection.",[24],"Procedure: aPDT with GC TriPlaque ID Gel",[26,33,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Mechanical Prophylaxis","Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.",[9],[32],"Dental cleaning",{"type":27,"name":15,"description":34,"armGroupLabels":35,"otherNames":36},"Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.",[15],[37],"Antimicrobial photodynamic therapy with erythrosine",{"type":27,"name":21,"description":39,"armGroupLabels":40,"otherNames":41},"Application of GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.",[21],[42],"Antimicrobial photodynamic therapy with GC TriPlaque ID Gel",null,{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Sandra Kalil Bussadori","Principal Investigator","100634399","disclosing-agents-as-photosensitizers-in-apdt-for-biofilm-control-in-children-100634399",false,"NCT07539181","Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children","Disclosing Agents as Photosensitizers in Antimicrobial Photodynamic Therapy for Biofilm Control in Children Aged 3 to 7 Years: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 3 to 7 years\n* Both sexes\n* Good general health status\n* Classified as high caries risk according to the CAMBRA protocol (score ≥ +4 or presence of at least one disease indicator associated with two or more biological risk factors)\n* Written informed consent obtained from a parent or legal guardian\n\nExclusion Criteria:\n\n* Presence of systemic diseases\n* Use of antibiotics within the last 30 days\n* Use of antimicrobial mouthwash within 48 hours prior to sample collection\n* Presence of structural dental alterations that may interfere with the standardization of the procedure\n* Uncooperative behavior preventing safe clinical examination and intervention","ALL","3 Years","7 Years",{"count":59,"type":60},72,"ESTIMATED","INTERVENTIONAL",[63],"NA","This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Participants will be allocated into groups to receive different treatment protocols, and biofilm levels will be assessed before and after the interventions. The primary outcome is the reduction of dental biofilm, aiming to determine whether disclosing agents can be an effective alternative photosensitizer in aPDT for pediatric patients.",[66],"Dental Plaque","NOT_YET_RECRUITING","2026-04-13",{"date":70,"type":71},"2026-04-20","ACTUAL",{"date":73,"type":60},"2026-05-31",{"date":75,"type":60},"2026-08-30",{"name":5,"class":6}]