Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07181967

SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dental Caries Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

Location status: Recruiting

Location contact

ِAhmed K Soliman, PDF

CONTACT

[email protected]

01061553007

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Silver allergy; ulcerative gingivitis/stomatitis.
  • Systemic antibiotics within 4 weeks.
  • Fixed appliances interfering with plaque assessment.
  • Conditions precluding safe participation per clinician judgment.

Treatment and study plan

Sodium Fluoride Varnish (5%)

Drug

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%)

Drug

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."

Primary outcomes

  1. Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ِAhmed Kamel soliman, PHD

CONTACT

[email protected]

+201061553007

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: Streptococcus

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.