Evaluation of the efficacy of silver diamine fluoride versus traditional varnishes in arresting early childhood caries: A randomized controlled trial

Project Abstract

This randomized controlled trial evaluated the comparative efficacy of silver diamine fluoride (SDF) versus conventional fluoride varnish in arresting early childhood caries (ECC) over a 24-month follow-up period among children aged 3–5 years presenting with active carious lesions. A total of 260 participants were recruited from five community dental clinics and randomized into two parallel groups SDF application and fluoride varnish application, with a 11 allocation and stratification by initial caries severity. The primary outcome was caries arrest rate, defined as the absence of radiographic progression and no new cavitated lesions in the treated sites at 12 and 24 months. Secondary outcomes included the speed of arrest, user acceptability, aesthetic concerns, parental satisfaction, frequency of adverse events, and cost-effectiveness from a health-system perspective. Interventions were administered biannually for 24 months following standardized protocols. SDF was applied to all active lesions after cleansing and isolation, while varnish was applied to all lesions in the control group. Caries status was evaluated clinically and radiographically at baseline, 6, 12, 18, and 24 months by calibrated examiners blinded to treatment assignment. The study also incorporated patient-reported outcomes through caregiver questionnaires addressing acceptability, tooth sensitivity, and perceived cosmetic impact, particularly the black staining associated with SDF. Results demonstrated that the SDF group achieved a significantly higher caries arrest rate at 12 months (78.5%) compared with the varnish group (54.2%), with sustained superiority at 24 months (SDF 69.8% vs varnish 44.7%). The median time to arrest was shorter in the SDF cohort (4 months) relative to varnish (8 months). Subgroup analyses indicated greater efficacy of SDF in teeth with multiple active lesions and in younger children (3–4 years) where cooperation for varnish application was limited. Aesthetic concerns due to staining were reported by 64% of caregivers in the SDF arm but did not significantly affect reported satisfaction with treatment outcomes, particularly when caries arrest was achieved. Adverse events were rare and mild, with transient gum irritation in a small proportion of participants unrelated to systemic toxicity. No significant differences were observed in growth metrics or weight gain between groups. Economic analysis revealed that the SDF strategy reduced direct dental treatment costs by lowering operative time, anesthesia usage, and need for operative restorations, yielding a favorable incremental cost-effectiveness ratio in comparison with varnish. Sensitivity analyses confirmed robustness of the findings under varying costs and adherence rates. The study supports the use of SDF as an effective, efficient, and acceptable approach to arrest ECC in high-risk populations, while acknowledging the cosmetic trade-off and caregiver preferences that influence uptake. Limitations include potential bias from caregiver-reported outcomes and the single-blind design for examiners due to the visible staining. Future research should explore long-term durability beyond 24 months, combined preventive regimens, and population-specific strategies to optimize acceptance of SDF in diverse settings.

Project Overview

What This Project Is About

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A straightforward study comparing two common treatments used to prevent and control early tooth decay in young children. It looks at how effective silver diamine fluoride (a liquid that can stop decay) is compared with traditional varnishes (protective coatings) in stopping caries from progressing in preschool-aged kids.

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The Problem It Addresses

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Many young children develop early childhood caries, which can lead to pain, eating problems, and costly dental care. There is ongoing debate about the best preventive treatments. This project investigates which option works better in real-world dental care settings.

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Objectives of the Project

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1. Compare the effectiveness of silver diamine fluoride and traditional varnishes in arresting early childhood caries.
2. Assess safety, side effects, and acceptance by parents and children.
3. Measure how often treatments require additional dental work over a defined period.
4. Provide practical guidance for clinicians on choosing between these treatments.

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What You Will Do Step by Step

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1) Review how these treatments work and collect background information. 2) Recruit eligible child participants and obtain consent from parents. 3) Apply treatments to affected teeth per protocol. 4) Schedule follow-up visits to check for arrest of decay and any adverse effects. 5) Record outcomes and analyze data using basic comparisons between groups. 6) Interpret results and consider limitations and implications for practice.

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Expected Outcome

The project is expected to show whether silver diamine fluoride or varnishes more effectively halt decay, with acceptable safety and parental acceptance, guiding dentists in making evidence-based treatment choices for young children.