[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553669":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":75,"collaborators":44,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":44,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":44,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":62,"whyStopped":44,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Plovdiv Medical University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"NSF (Gr-N)","EXPERIMENTAL","The Gr-N will receive treatment with green synthesized Nano silver fluoride which is laboratory conducted",[13],"Drug: NSF",{"label":15,"type":16,"description":17,"interventionNames":18},"SDF+KI group (Gr-S)","ACTIVE_COMPARATOR","The Gr-S will receive treatment with SDF + KI (Riva Star 38% , SDI) according to the manufacturer's instructions.",[19],"Drug: SDF+KI",{"label":21,"type":22,"description":23,"interventionNames":24},"Control group (Gr-C)","PLACEBO_COMPARATOR","The control group (Gr-C) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.",[25],"Other: Control group",[27,34,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","NSF","Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of NSF using a microapplicator on the carious lesion for 1 minute. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.",[9],[33],"green synthesized Nano silver fluoride",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"SDF+KI","Prior to treatment the working field is isolated with cotton rolls. Gingival barrier is used for soft tissue protection. Application of 38% silver diamine fluoride (Riva star 38%, SDI) using a microapplicator on the carious lesion. Immediately afterwards, potassium iodide is applied as a reducing agent. Excess material and gingival barrier are removed. Participants receive oral hygiene instructions.",[15],[39],"Riva star 38%, SDI",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Control group","Subjects will receive oral hygiene instructioins to apply fluoridated toothpaste to a toothbrush and brush teeth thoroughly for at least 2 minutes, then expectorate and rinse.",[21],null,[46],{"name":47,"affiliation":48,"role":49},"Antonia Palankalieva, DMD","Department Of Pediatric Dentistry, Faculty Of Dental Medicine, Medical University Of Plovdiv, Bulgaria","PRINCIPAL_INVESTIGATOR",[51,55],{"name":47,"role":52,"phone":53,"phoneExt":44,"email":54},"CONTACT","+359889205904","antonia.palankalieva@mu-plovdiv.bg",{"name":56,"role":52,"phone":57,"phoneExt":44,"email":58},"Ani Belcheva, DMD, PhD","+359889528932","ani.belcheva@mu-plovdiv.bg",[60],{"facility":61,"status":62,"city":63,"state":44,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University-Plovdiv","RECRUITING","Plovdiv","4000","Bulgaria","BG",{"type":68,"coordinates":69},"Point",[70,71],24.75001,42.15387,{"lat":71,"lon":70},[74],{"name":47,"role":52,"phone":53,"phoneExt":44,"email":54},{"type":76,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100553669","early-phase-1-remineralizing-effect-of-different-silver-containing-agents-on-initial-caries-lesions-in-primary-teeth-in-children-100553669",false,"NCT06489093","Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children","Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children","Inclusion Criteria:\n\n* Age: 3 - 8 years\n* Signed informed consent from parents to participate in the study. Verbal consent from the child for the upcoming manipulations.\n* Enrolled patients do not have any common diseases or conditions associated with decreased salivation and are not taking medications that suppress salivary flow. Study participants have no cognitive or behavioral impairment. The absence of disease will be confirmed by a history-taking interview with the parent.\n* Presence of incipient carious lesions (white spots) reaching the enamel interior, assessed with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change) and laser fluorescence values up to 20. The diagnostic threshold of the included lesions is defined as D1 A (active enamel lesion visible after drying) or D2 A (active enamel lesion visible without drying). Criteria for active lesions: under plaque, loss of gloss, loss of smoothness, diffuse borders of the lesion, opaque appearance, white colour, at pre-selection sites (in the cervical third of the enamel). The lesions are located on tooth surfaces with no preceding obturations.\n* Study participants had not performed remineralization or topical fluoride therapy on the included lesions within six months prior to study inclusion.\n* Children with no history of allergy to the medications administered.\n\nExclusion Criteria:\n\n* Children who are considered medically compromised or medically complex patients. The presence of a medical condition is confirmed by a history interview with the child's parent or guardian and involves common diseases or conditions associated with decreased salivation and intake of medications that suppress salivary flow, cognitive and behavioral disorders.\n* Patients who underwent remineralizing or topical fluoride therapy to the included lesions in the last six months prior to study inclusion.\n* Patients with a history of allergy to the administered medication.",true,"ALL","3 Years","8 Years",{"count":89,"type":90},30,"ESTIMATED","INTERVENTIONAL",[93],"EARLY_PHASE1","The aim of the present work is to study the effect of the application of Silver diamine fluoride (SDF) and a novel green synthesized Nano-silver fluoride (NSF) on early enamel lesions in primary teeth. Proving their positive effect would be the basis for the development of innovative dental materials and hygienic agents to combat the carious process, which is a critical prerequisite for improving the quality of dental services and reducing dental anxiety and fear.",[96],"White Spot Lesion of Tooth",[98,99,100],"sdf","nano silver fluoride","white spot lesions","2024-07-03",{"date":103,"type":104},"2024-07-05","ACTUAL",{"date":106,"type":90},"2024-07-29",{"date":108,"type":90},"2025-06",{"name":5,"class":6},1]