Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel

The University of Hong Kong (HKU)

Status and phase: Enrolling; Phase 2

Conditions: Early Childhood Caries

Treatments: Drug: Silver diamine fluoride solution; Drug: Silver diamine fluoride gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06241261

UW 23-064

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 630 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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630 participants in 2 patient groups

Silver diamine fluoride gel

Experimental group

Description:

38% silver diamine fluoride gel

Treatment:

Drug: Silver diamine fluoride gel

Silver diamine fluoride solution

Active Comparator group

Description:

38% silver diamine fluoride solution

Treatment:

Drug: Silver diamine fluoride solution