Journal of pharmacy & bioallied sciences · 2025
Protocol for Effectiveness of Silver Diamine Fluoride in Arresting Caries in 3-6-year-old Children: A Community-Based Randomized Control Trial.
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Sharma Swati, Shahi Ajoy Kumar, Saigal Sonal, Arunesh Kumar, Kumar Sandeep, Sinha Swati, Tripathi Praveen Kumar
Аннотация
BACKGROUND: Early childhood caries is a significant public health issue in India, particularly in underserved rural and tribal communities. Silver diamine fluoride (SDF) has emerged as a noninvasive, low-cost treatment to arrest dental caries in young children. This study evaluates the effectiveness of 38% SDF compared to high-fluoride-releasing glass ionomer cement (GIC) in arresting active dentinal caries among preschool children attending Anganwadi Kendras in the Angara Block, Ranchi.
METHODS: A parallel-group, stratified cluster randomized controlled trial will be conducted over 24 months. A total of 400 children aged 3-6 years with the International Caries Detection and Assessment System (ICDAS) score of 5 or 6 active caries lesions will be recruited from 60 Anganwadi centres across six sectors in Angara Block, Ranchi. Children will be randomized at the Anganwadi cluster level into two groups: Group A (intervention) will receive 38% SDF and Group B (control) will receive high fluoride GIC restorations. Caries arrest will be evaluated using ICDAS criteria and visual-tactile assessment at 6, 12, 18, and 24 months.
EXPECTED OUTCOMES: The study anticipates that SDF will demonstrate comparable or superior efficacy in arresting caries relative to GIC in a community setting. Findings will support the use of SDF as a cost-effective, minimally invasive strategy suitable for integration into national oral health programs targeting young children in resource-constrained environments.
METHODS: A parallel-group, stratified cluster randomized controlled trial will be conducted over 24 months. A total of 400 children aged 3-6 years with the International Caries Detection and Assessment System (ICDAS) score of 5 or 6 active caries lesions will be recruited from 60 Anganwadi centres across six sectors in Angara Block, Ranchi. Children will be randomized at the Anganwadi cluster level into two groups: Group A (intervention) will receive 38% SDF and Group B (control) will receive high fluoride GIC restorations. Caries arrest will be evaluated using ICDAS criteria and visual-tactile assessment at 6, 12, 18, and 24 months.
EXPECTED OUTCOMES: The study anticipates that SDF will demonstrate comparable or superior efficacy in arresting caries relative to GIC in a community setting. Findings will support the use of SDF as a cost-effective, minimally invasive strategy suitable for integration into national oral health programs targeting young children in resource-constrained environments.