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RECRUITING
NCT07181967
NA

SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children

Sponsor: Assiut University

View on ClinicalTrials.gov

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.

Official title: Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children

Key Details

Gender

All

Age Range

3 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-09-15

Completion Date

2025-12-30

Last Updated

2025-11-18

Healthy Volunteers

No

Conditions

Interventions

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."

Locations (1)

Assiut University

Asyut, Asyut Governorate, Egypt