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Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

NCT05642494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-07-19

No results posted yet for this study

Summary

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.

This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.

Conditions

  • Early Childhood Caries

Interventions

DEVICE

SDF

Silver Diamine Fluoride 38% (Applied bianually)

DEVICE

NaF

Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months)

Sponsors & Collaborators

  • Science, Technology & Innovation Funding Authority (STDF)

    collaborator UNKNOWN

  • Alexandria University

    lead OTHER

Principal Investigators

  • Enas B Abdellatif, Bachelor · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-03-30
Completion
2023-04-30
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642494 on ClinicalTrials.gov