NCT07181967

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	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.
DRUG	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."

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-12-15
• Completion: 2025-12-30
• First posted: 2025-09-19
• Last updated: 2025-11-18

Locations

1 site across 1 country: Egypt