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

Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05761041

Enrollment

140

Registered

2023-03-09

Start date

2022-03-28

Completion date

2023-04-15

Last updated

2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Caries

Keywords

ECC, 38% SDF, 5% NaF, Motivational Interviewing, Preschoolers

Brief 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.

Interventions

DRUGSodium Fluoride Varnish (5%)

Applied at baseline

BEHAVIORALMotivational Interviewing

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

DRUGSDF

Applied bianually

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 4 Years

Healthy volunteers

Inclusion criteria

1. Children aged ≤ 4 years old. 2. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II) 3. Children whose caregivers have means of communication (mobile phones). 4. Completion of an informed consent to participate in the study.

Exclusion criteria

1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess. 2. Parental refusal to participate in the study. 3. Allergy or sensitivity to silver or any of the materials included in the study.

Design outcomes

Primary

Measure	Time frame	Description
Caries Arrest	6 months	Percentage of arrested carious lesions

Secondary

Measure	Time frame	Description
Caries Increment	6 months	Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)
Parental satisfaction	Baseline and 6 months	Parents will be asked if application was an easy process, pain free for their child and taste is acceptable. Answers will be on a 5 point Likert scale (Strongly agree, Agree, Neutral , Disagree, Strongly disagree).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026