[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641568":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":68,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Malaya","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Application of Silver Fluoride","PLACEBO_COMPARATOR","Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months",[13,14],"Drug: 38% Silver Fluoride (Riva Star Aqua)","Other: Normal saline (palcebo)",{"label":16,"type":17,"description":18,"interventionNames":19},"Dual Application of Silver Fluoride","EXPERIMENTAL","Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","38% Silver Fluoride (Riva Star Aqua)","Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up. One drop (0.05 mL) treats up to five surfaces. Maximum dose per visit does not exceed 260 µL.",[16,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal saline (palcebo)","Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months",[9],[32],{"name":33,"affiliation":34,"role":35},"Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD","Universiti Malaya","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+6010-2716747","azlida@um.edu.my",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent","+6012-5250520","tengkunurfarhana@um.edu.my",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Preschools in Perak","Tapah","Perak","35000","Malaysia","MY",{"type":54,"coordinates":55},"Point",[56,57],101.26667,4.18333,{"lat":57,"lon":56},[60,64,66],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":63},"Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate","016-7786161","dr.mohamadnoor@moh.gov.my",{"name":65,"role":35,"phone":26,"phoneExt":26,"email":26},"Nurfazlina Rosman (Dr), DDS, MCOH",{"name":61,"role":67,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Nurfazlina binti Rosman","Principal Investigator","100641568","phase-3-effectiveness-of-single-and-dual-silver-fluoride-application-100641568",false,"NCT07658690","Effectiveness of Single and Dual Silver Fluoride Application","The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial","Inclusion Criteria:\n\n1. Children aged 4-6 years enrolled in selected preschools.\n2. Presence of at least one active dentinal caries lesion.\n3. Parental or guardian consent obtained.\n4. Asymptomatic cavitated dentine carious lesions in primary teeth.\n5. Parents\u002Fcaregivers who understand the Malay language.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms of irreversible pulpitis or dental abscess\u002Ffistula.\n2. Systemic illness or medical contraindications for SF use.\n3. Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.\n4. History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).\n5. Children who have received professionally applied fluoride within the past six months at the time of recruitment.\n6. Arrested caries lesion.\n7. Children presenting with oral ulceration or mucositis.\n8. Uncooperative behaviour precluding oral examination.\n9. Children with pre-shedding tooth mobility","ALL","4 Years","6 Years",{"count":82,"type":83},138,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years.\n\nThe main questions this study aims to answer are:\n\ni) Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire?\n\nResearchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes.\n\nParticipants will:\n\ni) Undergo oral examination for assessment of dentinal caries using ICDAS criteria.\n\nii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months.\n\niii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status.\n\niv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.",[89],"Dentine Caries",[91,92,93,94,95],"Silver Fluoride","Caries Arrest","Randomised Controlled Trial","Preschool Children","Silver Diamine Fluoride","NOT_YET_RECRUITING","2026-06-16",{"date":99,"type":100},"2026-06-22","ACTUAL",{"date":102,"type":83},"2026-09",{"date":104,"type":83},"2028-02",{"name":5,"class":6},1]