Silver diamine fluoride vs fluoride varnish to lower Streptococcus mutans in children
Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
This trial will see if applying 38% silver diamine fluoride on one side of the mouth and 5% fluoride varnish on the other lowers Streptococcus mutans in children aged 3–8 with bilateral cavities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT07181967 on ClinicalTrials.gov |
What this trial studies
This randomized split-mouth trial enrolls cooperative children aged 3–8 who have at least two contralateral primary molars with active dentin caries. Each child receives 38% silver diamine fluoride on one side and 5% sodium fluoride varnish on the opposite side, with side allocation randomized. The primary outcome is change in Dentocult SM Strip Mutans scores in plaque measured over three months, and secondary outcomes include plaque index, bleeding on probing, and adverse events. Treatments and plaque assessments are conducted at the dental clinic at Assiut University.
Who should consider this trial
Good fit: Children aged 3–8 with cooperative behavior (Frankl ≥2) and at least two comparable active dentin caries on opposite primary molars whose parent or guardian can consent are ideal candidates.
Not a fit: Children with silver allergy, active ulcerative gingivitis or stomatitis, recent systemic antibiotics, fixed appliances that interfere with plaque assessment, or other clinician-identified contraindications likely will not benefit.
Why it matters
Potential benefit: If successful, this approach could offer a simple, chairside way to reduce cariogenic Streptococcus mutans and help control cavities in young children.
How similar studies have performed: Prior studies show silver diamine fluoride reliably arrests caries and can reduce mutans levels compared with no treatment and fluoride varnish reduces caries risk, but randomized split-mouth comparisons specifically measuring Streptococcus mutans reduction are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Asyut, Asyut Governorate
- Assiut University — Asyut, Asyut Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: ِAhmed Kamel soliman, PHD
- Email: a.k.soliman@hotmail.com
- Phone: +201061553007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.