Effectiveness of Silver Diamine Fluoride for Early Childhood Caries Among Children Aged 24 to 72 Months: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND The most prevalent chronic disease in children worldwide is dental caries. An important public health concern is the existence of one or more decayed, missing, or filled tooth surfaces (dmfs) in any primary teeth of preschool-aged children. Since 1969, SDF has been used to stop tooth decay in young children's primary teeth and prevent root caries in the elderly. OBJECTIVE The study's objective is to evaluate and compare the efficacy of 12%, 30%, and 38% silver diamine fluoride in preventing early childhood caries in 24-72 month old children in Mangaluru Taluk. METHODS This is a single-centre, randomized, active-controlled, parallel-group pragmatic trial. Children attending pre-schools of Mangalore taluk with 24 -72 months of age will be included in the study. Three groups will make up the study groups: Group 1 will receive 12% SDF applied semi-annually; Group 2 will receive 30% SDF applied semi-annually; and Group 3 will receive 38% SDF applied semi-annually. After six and twelve months, the principal examiner will conduct a clinical examination of the teeth utilizing visual and tactile assessment. Effectiveness of various concentration of SDF will be checked after 12 months. RESULTS The research was funded in September 2020, and data collection started from September, 2022. As of February 2023, 150 participants have enrolled in the study. The project is still underway, and it's expected to be completed in December of 2023. CONCLUSIONS The findings of this study will be beneficial for future studies for the management and prevention of early childhood caries. If SDF is effective in a school or community setting for caries prevention, it will be a significant milestone in the preventive dentistry. CLINICALTRIAL Clinical Trials Registry done with registration number CTRI/2020/02/023420