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

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.

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Key information

Conditions

Early Childhood Caries (ECC) Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

College of Dentistry, jazan University

Jizan, Jazan Region, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility.
Medically healthy children with no systemic disorders or developmental anomalies

Exclusion criteria

Parents refused consent for study
Any child with special health care needs or with any systemic ailments will be excluded from the study
Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes

Treatment and study plan

Silver Diamine Fluoride (SDF, 38%)

Drug

Silver diamine fluoride gel is applied in gel form

Sodium Fluoride with CPP-ACP

Drug

This is in a Topical fluoride varnish

Acidulated phospahate fluoride gel 1.23%

Drug

This is a topical fluoride application for 1 minute application

Primary outcomes

Dental caries arrest

Time frame: Caries arrest will be assessed 6 months after intervention

A lesion was considered active if a blunt dental probe penetrated the dentinal surface easily, whereas arrested caries resisted probe penetration, indicating surface hardening.

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Acronym: SDF

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 27, 2026
Registry last updated: Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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