SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children
Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
Assiut University
48 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
Summary
This randomized split-mouth clinical trial will compare the effectiveness of 38% silver diamine fluoride (SDF) versus 5% sodium fluoride varnish (FV) in reducing salivary Streptococcus mutans levels in children with bilateral caries. Each participant will receive SDF on one side of the mouth and FV on the contralateral side. The primary outcome is change in Dentocult SM Strip Mutans scores in plaque over 3 months. Secondary outcomes include plaque index, bleeding on probing, and adverse events.
Eligibility
Inclusion Criteria3
- Age 3-8 years; cooperative (Frankl ≥2).
- ≥2 contralateral primary molars with active dentin caries (ICDAS 3-5) of comparable severity.
- Parent/guardian consent; child assent when appropriate.
Exclusion Criteria4
- Silver allergy; ulcerative gingivitis/stomatitis.
- Systemic antibiotics within 4 weeks.
- Fixed appliances interfering with plaque assessment.
- Conditions precluding safe participation per clinician judgment.
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Interventions
Topical application of 5% sodium fluoride varnish (22,600 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the contralateral side of the mouth. Applied once using a disposable applicator per manufacturer's instructions. This distinguishes it from lower-concentration fluoride gels or multiple-application protocols in other clinical trials.
Topical application of 38% silver diamine fluoride solution (44,800 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the assigned side of the mouth. Applied once with a microbrush for 1 minute, per manufacturer's instructions, without subsequent rinsing. This concentration and protocol distinguish it from other concentrations of SDF or repeated-application protocols used in other clinical studies."
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07181967