Preventing Early Childhood Caries With a Silver Diamine F... | NCT07455604

Studies
Preventing Early Childhood Caries With a Silver Diamine Fluoride Gel

NCT07455604

Sponsor

The University of Hong Kong

Status

Active, not recruiting

Last Update Posted

Mar 6, 2026Actual

Enrollment

1,500Estimated

Phase

Phase 2

Conditions

Early Childhood Caries (ECC)

Interventions

Silver diamine fluoride gel
Sodium Fluoride varnish

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Actual

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Hung Chu, Prof, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Silver diamine fluoride gel	Drug	Application of 38% SDF gel every 6 months over 24 months	Silver diamine fluoride gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chun Hung Chu	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong		Hong Kong			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C094502	Bifluorid 12

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided