NCT07382245

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children

Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: October University for Modern Sciences and Arts · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration. This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.

Detailed description

This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group. Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires. The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.

Conditions

• Early Childhood Caries (ECC)
• Active Dentin Caries in Primary Molars

Interventions

Type	Name	Description
DRUG	Nano-Silver Fluoride	Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
DRUG	Silver Diamine Fluoride	38% Silver Diamine Fluoride

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-02-25
• Completion: 2026-03-15
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Egypt