[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fixed-appliances\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fixed-appliances":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100577406","phase-2-preventive-effects-of-silver-diamine-fluoride-on-early-enamel-caries-100577406",false,"NCT06797882","Preventive Effects of Silver Diamine Fluoride on Early Enamel Caries","The Effectiveness of Silver Diamine Fluoride (SDF) in the Prevention of Early Enamel Caries Among Patients With Fixed Orthodontic Appliances: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Subjects about to undergo fixed orthodontic treatment at the Faculty of Dentistry, UKM.\n* Subjects must be aged 18 years and above.\n* Consented for treatment. Patients will be informed of the risk and benefit of the study for each treatment group through the patient information sheet given to them before obtaining their consent.\n* Orthodontic brackets placed at least on the upper incisors.\n* Patients undergoing orthodontic treatment with conventional orthodontic brackets placed on the labial surface.\n* Any degree of malocclusion\n* Fit and healthy patient\n* Non-smoker\n* Subjects can understand and possessed basic command in English\n\nExclusion Criteria:\n\n* History of fixed orthodontic treatment\n* Presence of any dental anomalies or developmental defects of enamel (DDE) on labial surfaces of teeth, such as preexisting fluorosis or enamel hypoplasia.\n* Presence of any or direct\u002Findirect restorations on the labial surface of teeth\n* History of long-term antibiotic usage\n* Presence of untreated cavitated lesions, especially on upper and lower incisors and canines\n* Plaque levels \\>30%.\n* Patient allergic to any of the content of the intervention material (sodium fluoride, silver diamine fluoride, potassium iodide).\n* Patients with lingual brackets.",true,"ALL","18 Years",{"count":20,"type":21},99,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Fixed orthodontic patients are at risk of developing dental caries. Topical application of fluoride varnish (FV) around the orthodontic brackets and using fluoridated mouth rinses have been suggested to prevent the formation of white spot lesions (WSLs) on enamel. Recent studies have shown that silver diamine fluoride (SDF) demonstrated better outcomes in dental caries prevention as compared to FV. However, the caries preventive effects of SDF application around the orthodontic brackets have not been established yet.\n\nThis study will be conducted to evaluate the effectiveness of SDF in preventing WSLs formation in patients undergoing fixed orthodontic treatment. This study will use a randomised-controlled double-blinded design with three parallel arms. Ninety-nine eligible participants will be recruited. Using their registration number, a random list of patients will be generated using computer software. Each patient will be assigned randomly to three groups: SDF, FV, or placebo. Digital photographs of upper anterior teeth (frontal view) will be taken as a baseline and repeated at every review appointment. The materials will be applied around the orthodontic bracket of upper incisors and canines every 6 months. The formation of WSLs around the bracket will be evaluated at 1, 3, 6, and 12 months using three parameters: the ICDAS scoring system, the laser fluorescence caries detector, and digital photographic analysis using the Gorelick score. The patients' perception of the colour changes of the enamel will be evaluated through patient-reported outcomes. The difference in ICDAS and Gorelick scores and the patients' perceptions will be reported through descriptive statistics. The Kruskal-Wallis or one-way ANOVA statistical test will be used to compare the changes in fluorescence intensity between treatment groups.\n\nThe investigators believe that the results of this study will provide insight into the caries preventive protocol among fixed orthodontics patients and subsequently reduce the incidence of WSLs during orthodontic treatment.",[27,28,29,30],"Demineralization, Tooth","White Spot Lesion of Tooth","Fixed Appliances","Early Caries Lesions",[30,32,33,34,35,36],"Silver Diamine Fluoride (SDF)","Fixed Orthodontic Appliances","Caries Prevention","Fluoride Varnish","White Spot Lesions","NOT_YET_RECRUITING","2025-01-28",{"date":40,"type":41},"2025-01-30","ACTUAL",{"date":43,"type":21},"2025-01-31",{"date":45,"type":21},"2026-12-31",{"name":47,"class":48},"National University of Malaysia","OTHER"]