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Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel

Randomised Clinical Trial to Arrest Early Childhood Caries With a Silver Diamine Fluoride Gel

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06241261
Enrollment
630
Registered
2024-02-05
Start date
2024-01-01
Completion date
2027-12-31
Last updated
2026-03-05

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

Conditions

Early Childhood Caries

Keywords

Silver Diamine Fluoride, Caries, Arrest, Gel, Children

Brief summary

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.

Detailed 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.

Interventions

Application of 38% SDF gel every 6 months

DRUGSilver diamine fluoride solution

Application of 38% SDF solution every 6 months

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The hardness of cavity on tooth by probingThe follow-up oral examinations will be conducted every 6 months for 30 months totallyThe number of active carious tooth surfaces that become arrested per child

Countries

China

Contacts

PRINCIPAL_INVESTIGATORChun Hung Chu, Ph.D

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026