SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Fluoride Varnish (5%), Silver Diamine Fluoride (38%).
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
Overview
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.
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."
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut University — Asyut
Identifiers
NCT: NCT07181967 · 17-2025-00013 · 17-2025-00013