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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2023-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05642494

Early Childhood Caries

COMPLETED PHASE3

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

NCT05255913

Early Childhood Caries

COMPLETED NA

Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

NCT04514094

Early Childhood Caries

COMPLETED NA

Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

NCT03557996

Dental Caries in Children

UNKNOWN PHASE4

Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children

NCT03480516

Dental Caries in Children Satisfaction Cost Effectiveness +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Childhood Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naf + MI

Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.

Group Type EXPERIMENTAL

Sodium Fluoride Varnish (5%)

Intervention Type DRUG

Applied at baseline

Motivational Interviewing

Intervention Type BEHAVIORAL

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

SDF

Silver Diamine fluoride 38% (Applied biannually)

Group Type ACTIVE_COMPARATOR

SDF

Intervention Type DRUG

Applied bianually

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Fluoride Varnish (5%)

Applied at baseline

Intervention Type DRUG

Motivational Interviewing

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

Intervention Type BEHAVIORAL

SDF

Applied bianually

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No