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

January 18, 2026 updated by: Renuga Lakshmi Apathsakayan, University of Jazan

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Jazan Region
      • Jizan, Jazan Region, Saudi Arabia
        • College of Dentistry, jazan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cavitated/Non cavitated caries lesions involving only enamel
Reversible pulpitis
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
Active Comparator: Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Caries arrest will be assessed 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jazan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODJU-21041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share the IPD because we consider to continue the study for long term in future

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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