NCT05761041

Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 1 Year – 4 Years
• Healthy volunteers: Not accepted

Summary

Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI). The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.

Conditions

• Early Childhood Caries

Interventions

Type	Name	Description
DRUG	Sodium Fluoride Varnish (5%)	Applied at baseline
BEHAVIORAL	Motivational Interviewing	Two MI sessions: face-to-face at baseline and phone call at 3 months
DRUG	SDF	Applied bianually

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-03-30
• Completion: 2023-04-15
• First posted: 2023-03-09
• Last updated: 2023-07-20

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study