SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children

Assiut University

Status: Enrolling

Conditions: Dental Caries

Treatments: Drug: Silver Diamine Fluoride (38%); Drug: Sodium Fluoride Varnish (5%)

Study type: Interventional

Funder types: Other

Identifiers

NCT07181967

17-2025-00013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Silver Diamine Fluoride (SDF)

Experimental group

Description:

Application of 38% silver diamine fluoride (44,800 ppm F) to all eligible dentin caries lesions on the assigned side of the mouth. Single application per manufacturer's instructions.

Treatment:

Drug: Silver Diamine Fluoride (38%)

Fluoride Varnish (FV)

Active Comparator group

Description:

Application of 5% sodium fluoride varnish (22,600 ppm F) to all eligible dentin caries lesions on the contralateral side of the mouth. Single application per manufacturer's instructions.

Treatment:

Drug: Sodium Fluoride Varnish (5%)