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

NCT07371117 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CODJU-21041
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

silver diamine fluoride

Outcome Measures

Primary Outcomes (1)

• Dental caries arrest

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

  Caries arrest will be assessed 6 months after intervention

Study Arms (2)

Cavitated/Non cavitated caries lesions involving only enamel

EXPERIMENTAL

Reversible pulpitis

Drug: Silver Diamine Fluoride (SDF, 38%); Drug: Sodium Fluoride with CPP-ACP; Drug: Acidulated phospahate fluoride gel 1.23%

Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p

ACTIVE COMPARATOR

Drug: Silver Diamine Fluoride (SDF, 38%); Drug: Sodium Fluoride with CPP-ACP; Drug: Acidulated phospahate fluoride gel 1.23%

Interventions

Acidulated phospahate fluoride gel 1.23% DRUG

This is a topical fluoride application for 1 minute application

Cavitated/Non cavitated caries lesions involving only enamel; Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p

Sodium Fluoride with CPP-ACP DRUG

This is in a Topical fluoride varnish

Cavitated/Non cavitated caries lesions involving only enamel; Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p

Silver Diamine Fluoride (SDF, 38%) DRUG

Silver diamine fluoride gel is applied in gel form

Cavitated/Non cavitated caries lesions involving only enamel; Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

College of Dentistry, jazan University

Jizan, Jazan Region, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride; Sodium Fluoride; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) for preventing or arresting dental caries.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)