Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-31

Brief Summary

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The objective is to determine whether the efficacy of a 38% silver diamine fluoride (SDF) gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children when applied at half-yearly intervals over a 30-month period.

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Detailed Description

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Aim: Silver diamine fluoride (SDF) is typically available as a 38% aqueous solution, which is runny and difficult to apply. A 38% SDF gel has been introduced but it has not been tested clinically. The objective is to determine whether the efficacy of a 38% SDF gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children.

Methods / Design: This non-inferiority randomised clinical trial will recruit 630 3- to 4-year-old children to receive either SDF gel or SDF solution on their carious lesions every 6 months. The primary outcome is the proportion of active carious tooth surfaces that arrest at the 30-month follow-up. The same examiner will conduct all examinations at the kindergartens over 30 months. The examiner, the children, and the children's parents will be blinded to treatments. The parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification.

Significance: If the result is as anticipated, SDF gel will prolong contact of SDF with the carious lesion to promote remineralisation. As SDF gel is cost-effective, simple, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control.

Conditions

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Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Silver diamine fluoride gel

38% silver diamine fluoride gel

Group Type EXPERIMENTAL

Silver diamine fluoride gel

Intervention Type DRUG

Application of 38% SDF gel every 6 months

Silver diamine fluoride solution

38% silver diamine fluoride solution

Group Type ACTIVE_COMPARATOR

Silver diamine fluoride solution

Intervention Type DRUG

Application of 38% SDF solution every 6 months

Interventions

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Silver diamine fluoride gel

Application of 38% SDF gel every 6 months

Intervention Type DRUG

Silver diamine fluoride solution

Application of 38% SDF solution every 6 months

Intervention Type DRUG

Other Intervention Names

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SDF gel SDF solution

Eligibility Criteria

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Inclusion Criteria

* generally healthy, have at least one tooth with cavitated dentine carious lesion

Exclusion Criteria

* uncooperative and difficult to manage, with severe forms of hypoplasia of fluorosis or other oral diseases, wearing orthodontic devices or under dental treatment, have major systemic diseases, or are on long-term medication

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes