SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children

NCT07181967 | Recruiting

• 1 other identifier: 17-2025-00013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Silver Diamine Fluoride; Fluoride Varnish; Streptococcus mutans; Dental Plaque

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 month

Study Arms (2)

Silver Diamine Fluoride (SDF)

EXPERIMENTAL

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.

Drug: Silver Diamine Fluoride (38%)

Fluoride Varnish (FV)

ACTIVE COMPARATOR

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.

Drug: Sodium Fluoride Varnish (5%)

Interventions

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.

Fluoride Varnish (FV)

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."

Silver Diamine Fluoride (SDF)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Central Study Contacts

ِAhmed Kamel soliman, PHD

CONTACT

+201061553007; a.k.soliman@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operator and participants could not be blinded because 38% silver diamine fluoride (SDF) produces visible black staining of carious lesions. The outcome assessor for Streptococcus mutans (Dentocult SM test) was blinded; plaque samples were coded, and the assessor had no knowledge of treatment allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Split-mouth randomized controlled trial. Each child receives 38% silver diamine fluoride (SDF) on one side and 5% sodium fluoride varnish (FV) on the contralateral side. This within-subject design minimizes inter-individual variability, with each participant serving as their own control.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)