Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre

April 27, 2026 updated by: Chun Hung Chu, The University of Hong Kong

Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Children: a Randomized Double Blinded Controlled Trial

To determine the optimal application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: The randomized double blinded clinical trial will recruit 665 healthy kindergarten children aged 3-5 years old with caries and with parental consent. The sample size is sufficient for the appropriate statistical analyses. The children will receive 0.004 mL 38% SDF (typical amount applied per manufacturer's instructions) to treat each caries lesion. The children will be classified into high and low caries rates and equably allocated into nine groups of SDF application time: 3, 5, 15, 30, 45, 60, 120 and 180 seconds. The children will be followed up for 6-months in their kindergartens. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested and surface color using a Pantone-based chart. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 6-months follow-up. The examiner, the children and the children's parents will be blind to the treatment allocation. The analysis will determine the significance of differences between the means of arrested caries at the various follow-ups; and Cochran-Armitage test will be used to evaluate the exposure (SDF-application time) to response relationship.

Significance: This study will help determine the optimal application time in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Study Type

Interventional

Enrollment (Actual)

665

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Local kindergartens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(a) 3-5 year old children attending the first to the third year of kindergarten; (b) free from any systemic conditions and generally healthy; (c) parents sign informed consent (d) having at least 1 tooth with cavitated dentine carious lesion.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3-second SDF application
3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 3-second SDF application
Dosage: 3-second 38% SDF solution application
Experimental: 5-second SDF application
5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 5-second SDF application
Dosage: 5-second 38% SDF solution application
Experimental: 10-second SDF application
10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 10-second SDF application
Dosage: 10-second 38% SDF solution application
Experimental: 15-second SDF application
15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 15-second SDF application
Dosage: 15-second 38% SDF solution application
Experimental: 30-second SDF application
30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 30-second SDF application
Dosage: 30-second 38% SDF solution application
Experimental: 45-second SDF application
45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children.
Other: 45-second SDF application
Dosage: 45-second 38% SDF solution application
Experimental: 60-second SDF application
60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 60-second SDF application
Dosage: 60-second 38% SDF solution application
Experimental: 120-second SDF application
120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 120-second SDF application
Dosage: 120-second 38% SDF solution application
Experimental: 180-second application time
180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Other: 180-second SDF application
Dosage: 180-second 38% SDF solution application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The visible plaque index (VPI).
Time Frame: at 6-months follow-up
Two areas (buccal and lingual) of each of the six index teeth (55/51/63/71/75/83) will be examined and recorded (presence/absence) without visible plaque.
at 6-months follow-up
dmft index
Time Frame: at 6-months follow-up
The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility
at 6-months follow-up
Clinical Status of Caries Arrest (Surface Hardness)
Time Frame: From enrollment to the end of treatment at 6 months
Surface hardness is independently evaluated by a calibrated examiner using a dental probe with a standard tactile technique. Lesions are classified as "Hard" (indicating successful caries arrest) or "Soft" (indicating an active, non-arrested lesion).
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Presentation of Lesion Coloration
Time Frame: From enrollment to the end of treatment at 6 months
This assessment evaluates the visual appearance of each dental caries lesion using a standardized Pantone-based coloration chart which including yellow, light brown, dark brown and black.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU20201127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Childhood Caries

Clinical Trials on 3-second SDF application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe