NCT07455604

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_2

Timeline
30mo left

Started Jan 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Early Childhood Caries (ECC)

Keywords

ChildrenPreschoolFluoride VarnishSilver Diamine FluorideCariesPrevention

Outcome Measures

Primary Outcomes (1)

  • Caries prevention

    The number of sound tooth surfaces that become cavitated caries per child

    The follow-up oral examinations will be conducted every 6 months for 24 months totally

Study Arms (2)

Silver diamine fluoride gel

EXPERIMENTAL

38% silver diamine fluoride gel

Drug: Silver diamine fluoride gel

Sodium Fluoride varnish

ACTIVE COMPARATOR

5% Sodium Fluoride varnish

Drug: Sodium Fluoride varnish

Interventions

Silver diamine fluoride gelDRUG

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

Also known as: SDF gel
Silver diamine fluoride gel
Sodium Fluoride varnishDRUG

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

Also known as: NaF varnish
Sodium Fluoride varnish

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • generally healthy, with parental consents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Interventions

Bifluorid 12

Study Officials

  • Chun Hung Chu

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)