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

BACKGROUND: Dental caries is a serious public health issue globally. It is one of the most prevalent chronic disease in children worldwide. An important public health concern is the existence of one or more decayed, missing, or filled tooth surfaces in any primary teeth of preschool children. Early childhood caries (ECC) can be halted with the use of silver diamine fluoride (SDF) solution. Previous research has indicated that it may have a preventive impact in the treatment of ECC. It is well known that 38% silver diamine fluoride (SDF) is helpful at preventing dental caries. On the other hand, there is not enough evidence on SDF’s ability to prevent caries in primary teeth. To date, no well-planned clinical study has been carried out to investigate SDF’s impact on caries protection. OBJECTIVE: The study’s objective is to evaluate and compare the efficacy of 12%, 30%, and 38% silver diamine fluoride in preventing ECC in children aged 24 to 72 months in Mangaluru Taluk. METHODS: This is a single-center, randomized, active-controlled, parallel-group pragmatic trial. Children attending preschool in Mangalore Taluk aged 24 to 72 months will be included in the study. There will be three study groups: group 1 will receive 12% SDF semiannually; group 2 will receive 30% SDF semiannually; and group 3 will receive 38% SDF semiannually. After 6 and 12 months, the principal examiner will conduct a clinical examination of the teeth with a visual and tactile assessment. The effectiveness of the various concentrations of SDF will be determined after 12 months. RESULTS: The research was funded in September 2020, and data collection started in September 2022. As of February 2023, 150 participants have enrolled in the study. The project is still underway, and it is expected to be completed in December 2023. CONCLUSIONS: Uncertainty surrounds the efficacy of 38% SDF in preventing ECC. Consensus-Based Clinical Case Reporting (CARE) guidelines recommending the use of SDF for ECC prevention will be modified if the findings are as expected. Additionally, since the findings will be broadly disseminated, more nations will implement the use of SDF, easing the burden of ECC on the entire world. Future research on the treatment and prevention of ECC will benefit from the study results. If SDF is successful in preventing caries in a classroom or community context, it will mark an important turning point for preventive dentistry. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2020/02/023420; https://tinyurl.com/3ju2apab INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46144