SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

Sodium Fluoride Varnish (5%): 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.

Silver Diamine Fluoride (38%): 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."

Study 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

Primary outcome measure(s)

• Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months — 3 month
  Streptococcus mutans levels will be assessed using the Dentocult SM Strip Mutans test (Orion Diagnostica/Aidian). The test provides a semi-quantitative estimate of salivary S. mutans based on colony density on a selective culture strip.

Trial sites (1)

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