Dental Caries
Conditions
Keywords
Silver Diamine Fluoride; Fluoride Varnish; Streptococcus mutans; Dental Plaque
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.
Interventions
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.
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months | 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. |
Countries
Egypt
Contacts
Primary ContactِAhmed Kamel soliman, PHD
Outcome results
None listed