drugset / Trial / NCT07371117

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

NCT07371117

Phase 2 Active not recruiting 90 enrolled University of Jazan
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-11-01
Primary completion
2026-01
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Acidulated Phosphate Fluoride Unknown 1.23 % Topical
Subject Casein phosphopeptide amorphous calcium phosphate Peptide Topical
Subject silver diammine fluoride Small molecule 38 %
Subject sodium fluoride Unknown Topical

Indications