NCT05642494

Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

Comparison of the Effectiveness of Silver Diamine Fluoride Versus Silver Diamine Fluoride Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries: A Randomised Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 1 Year – 4 Years
• Healthy volunteers: Not accepted

Summary

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions. This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.

Conditions

• Early Childhood Caries

Interventions

Type	Name	Description
DEVICE	SDF	Silver Diamine Fluoride 38% (Applied bianually)
DEVICE	NaF	Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months)

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-30
• Completion: 2023-04-30
• First posted: 2022-12-08
• Last updated: 2023-07-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study