NCT07371117

Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries - A Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Jazan · Other Government
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited. This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.

Conditions

• Early Childhood Caries (ECC)
• Dental Caries

Interventions

Type	Name	Description
DRUG	Silver Diamine Fluoride (SDF, 38%)	Silver diamine fluoride gel is applied in gel form
DRUG	Sodium Fluoride with CPP-ACP	This is in a Topical fluoride varnish
DRUG	Acidulated phospahate fluoride gel 1.23%	This is a topical fluoride application for 1 minute application

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: Saudi Arabia