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Preventing Early Childhood Caries With a Silver Diamine Fluoride Gel

Randomized Clinical Trial to Prevent Early Childhood Caries With a Silver Diamine Fluoride Gel

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07455604
Enrollment
1500
Registered
2026-03-06
Start date
2026-01-01
Completion date
2028-12-31
Last updated
2026-03-06

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

Conditions

Early Childhood Caries (ECC)

Keywords

Children, Preschool, Fluoride Varnish, Silver Diamine Fluoride, Caries, Prevention

Brief summary

The objective is to compare the efficacy of SDF gel with that of NaF varnish in preventing carious lesions in preschool children when applied at half-yearly intervals over a 24-month period.

Detailed description

Aim: The World Health Organization (WHO) included SDF in the WHO Model List of Essential Medicines. 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 compare the efficacy of SDF gel with that of NaF varnish in preventing carious lesions in preschool children when applied at half-yearly intervals over a 24-month period. Methods / Design: This non-inferiority randomised clinical trial will recruit 1500 3- to 4-year-old children to receive either SDF gel or NaF varnish every 6 months. The primary outcome is SDF gel will be more effective than NaF varnish in preventing ECC when both are applied at half-yearly intervals at the 24-month follow-up. The same examiner will conduct all examinations at the kindergartens over 24 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. Discussion: If the result is as anticipated, clinicians can use SDF gel instead of NaF varnish to prevent ECC. As SDF gel is cost-effective, simple, non-invasive, and non-aerosol generating, it can be widely recommended for prevent early childhood caries. This study will help change the standard of preventive care. If SDF gel is adopted in Hong Kong, it could prevent kindergarten children from developing ECC, thus significantly reducing the burden of ECC among children and the related stress on their families.

Interventions

Application of 38% SDF gel every 6 months over 24 months

Application of 5% NaF varnish every 6 months over 24 months

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

* generally healthy, with parental consents

Exclusion criteria

* uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Design outcomes

Primary

MeasureTime frameDescription
Caries preventionThe follow-up oral examinations will be conducted every 6 months for 24 months totallyThe number of sound tooth surfaces that become cavitated caries per child

Countries

China

Contacts

PRINCIPAL_INVESTIGATORChun Hung Chu

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026