protocolSection identificationModule nctId: NCT06316323, orgStudyIdInfo id: REC/09/2021 (FB/51), briefTitle: The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-09-29, completionDateStruct date: 2024-01-26, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universiti Teknologi Mara, class: OTHER, descriptionModule briefSummary: Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management., conditionsModule conditions: Early Childhood Caries, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one group received silver diamine fluoride treatment, and another group received sodium fluoride varnish treatment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Subjects that participated in this study were randomly allocated to two groups; Group A and Group B. Group A subjects were treated with 38% SDF and Group B subjects were treated with 5% NaF varnish. The randomisations of the subjects were done using a sealed envelope. Sequentially numbered, opaque sealed envelopes (SNOSE) method was used for the allocation concealments. This study was conducted in a non-blinded manner, as it was deemed impossible to blind the subjects. The treatment solutions utilized in this study were clearly distinct, with the SDF solution comprising a two-step process, while NaF varnish only required a single step. Additionally, the treatments exhibited different colors and textures. Consequently, the principal investigator had to closely supervise the treatment of each group. Due to the risk of blackish staining associated with SDF, parents and children were not blinded and were informed of the treatment they would receive., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: Silver diamine fluoride, interventions name: Sodium fluoride, outcomesModule primaryOutcomes measure: comparison of salivary pH, primaryOutcomes measure: comparison of salivary counts of Streptococcus mutans, primaryOutcomes measure: comparison of salivary counts of Lactobacillus, secondaryOutcomes measure: Detection and comparison of salivary counts of Lactobacillus acidophilus, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Technology MARA, city: Sungai Buloh, state: Selangor, zip: 47000, country: Malaysia, geoPoint lat: 3.2, lon: 101.58333, hasResults: False