The Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish on Salivary pH and Streptococcus Mutans and Lactobacillus in Early Childhood Caries: A Randomized Control Trial

REC/09/2021 (FB/51)

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.

2023-02-01

2023-09-29

2024-01-26

Completed

Early phase I

49

Inclusion Criteria: * Children under 6 years old, with ECC, having at least one active dentinal caries were included in this study. The cavitated tooth was assessed using International Caries Detection and Assessment System (ICDAS). Children that only had the tooth that fulfilled the ICDAS score 5 were included. This is characterized by a distinct cavity with visible dentine, not including more than half of the tooth. The tooth must not be mobile, associated with abscess, or have the symptoms of irreversible pulpitis. Children that had been included in this study must have not been on antibiotic treatment for at least 3 months before the start of the study and not being put on such treatment throughout the study period Exclusion Criteria: * Children with any severe medical conditions, emotional or physical disorders were excluded from the study. Children that had been using chlorhexidine mouthwashes within 2 weeks before the baseline appointment or professional topical fluoride was applied in the past 6 months were also excluded. Another exclusion criteria are children that had gingival or perioral ulceration or stomatitis, or a tooth abscess, have a history of chemical allergies to silver, fluoride, potassium, iodine, and ammonia, and uncooperative child. Besides that, parents and children that were refused any type of treatment were excluded. Children who did not complete the follow up were considered dropouts.

{'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'}}

2024-03-18