[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460179":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":63,"collaborators":41,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":41,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":41,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Povidone Iodine","EXPERIMENTAL","10% povidone iodine + fluoride varnish",[13],"Drug: 10% povidone iodine + FV",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (iced tea) + fluoride varnish",[19],"Other: Placebo +FV",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","10% povidone iodine + FV","applied to children's teeth",[9],[27],"betadine",{"type":6,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Placebo +FV",[15],[32],"Iced tea",[34],{"name":35,"affiliation":5,"role":36},"Dorota T Kopycka-Kedzierawski, DDS, MPH","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","585-275-0706",null,"Dorota_KopyckaKedzierawski@urmc.rochester.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Kathy Bohn","585-273-5272","Kathy_Bohn@urmc.rochester.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Rochester","New York","14620","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.61556,43.15478,{"lat":59,"lon":58},[62],{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},{"type":36,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Dorota Kopycka-Kedzierawski","Professor","100460179","phase-2-povidone-iodine-efficacy-study-100460179",false,"NCT05272254","Povidone Iodine Efficacy Study","PIES","Inclusion Criteria:\n\n* Provide signed and dated informed consent\u002Fpermission form\n* Parents\u002Fprimary caregivers willing to comply with all study procedures and be available for the duration of the study\n* Male or female, of any race, ethnicity, aged 24 to 71 months and their parents\u002Fprimary caregivers who are 18 years of age or older or emancipated minors\n* In good general health as evidenced by medical history, per PI, and in compliance with current CDC, NYS Department of Health and URMC COVID-19 guidelines. American Society of Anesthesiologists (ASA) categories will be used; children classified as ASA I and ASA II will be eligible for the study.\n* Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR). A diagnosis of S-ECC will be based on the definition in accordance with American Academy of Pediatric Dentistry (AAPD)\n\nExclusion Criteria:\n\n* Having a known allergy or sensitivity to iodine or seafood, red or yellow food coloring, or to tea, including a hypersensitivity to fluoride varnish, or having thyroid disease, as determined by medical history\n* Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1)",true,"ALL","24 Months","71 Months",{"count":78,"type":79},202,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This is a single center, randomized, double-blind, placebo-controlled Phase II clinical trial (RCT) to evaluate the efficacy of topical 10% Polyvinylpyrrolidone-Iodine (PVPI) to prevent new caries lesions when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). At baseline, following oral rehabilitation in the operating room {10% (PVPI + Fluoride Varnish (FV)} will be compared to the current standard of care (Placebo + FV). Study participants will be followed for approximately 24 months post-baseline. The study interventions post-baseline will be administered at 3, 6, 9, 12, 15, 18, and 21 months.",[85],"Early Childhood Caries","2026-02-24",{"date":88,"type":89},"2026-02-27","ACTUAL",{"date":91,"type":89},"2022-09-15",{"date":93,"type":79},"2027-05",{"name":5,"class":6},1]