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Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

NCT05761041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-07-20

No results posted yet for this study

Summary

Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).

The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.

Conditions

  • Early Childhood Caries

Interventions

DRUG

Sodium Fluoride Varnish (5%)

Applied at baseline

BEHAVIORAL

Motivational Interviewing

Two MI sessions: face-to-face at baseline and phone call at 3 months

DRUG

SDF

Applied bianually

Sponsors & Collaborators

  • Science, Technology & Innovation Funding Authority (STDF)

    collaborator UNKNOWN

  • Alexandria University

    lead OTHER

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
2022-03-28
Primary Completion
2023-03-30
Completion
2023-04-15
FDA Drug
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 NCT05761041 on ClinicalTrials.gov