nctId: NCT06316323 id: REC/09/2021 (FB/51) briefTitle: The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish overallStatus: COMPLETED date: 2023-02-01 date: 2023-09-29 date: 2024-01-26 date: 2024-03-18 date: 2024-03-18 name: Universiti Teknologi Mara class: OTHER 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. conditions: Early Childhood Caries studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one group received silver diamine fluoride treatment, and another group received sodium fluoride varnish treatment primaryPurpose: TREATMENT 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 count: 49 type: ACTUAL name: Silver diamine fluoride name: Sodium fluoride measure: comparison of salivary pH measure: comparison of salivary counts of Streptococcus mutans measure: comparison of salivary counts of Lactobacillus measure: Detection and comparison of salivary counts of Lactobacillus acidophilus sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University Technology MARA city: Sungai Buloh state: Selangor zip: 47000 country: Malaysia lat: 3.2 lon: 101.58333 hasResults: False