NCT04655430

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
665

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

April 28, 2026

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

November 30, 2020

Last Update Submit

April 27, 2026

Conditions

Early Childhood Caries

Keywords

silver diamine fluorideapplication timepreschool childrenearly childhood caries

Outcome Measures

Primary Outcomes (3)

  • Clinical Status of Caries Arrest (Surface Hardness)

    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

  • dmft index

    The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility

    at 6-months follow-up

  • The visible plaque index (VPI).

    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

Secondary Outcomes (1)

  • Clinical Presentation of Lesion Coloration

    From enrollment to the end of treatment at 6 months

Study Arms (9)

3-second SDF application

EXPERIMENTAL

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

5-second SDF application

EXPERIMENTAL

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

10-second SDF application

EXPERIMENTAL

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

15-second SDF application

EXPERIMENTAL

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

30-second SDF application

EXPERIMENTAL

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

45-second SDF application

EXPERIMENTAL

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

60-second SDF application

EXPERIMENTAL

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

120-second SDF application

EXPERIMENTAL

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

180-second application time

EXPERIMENTAL

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

Interventions

3-second SDF applicationOTHER

Dosage: 3-second 38% SDF solution application

3-second SDF application
5-second SDF applicationOTHER

Dosage: 5-second 38% SDF solution application

5-second SDF application
10-second SDF applicationOTHER

Dosage: 10-second 38% SDF solution application

10-second SDF application
15-second SDF applicationOTHER

Dosage: 15-second 38% SDF solution application

15-second SDF application
30-second SDF applicationOTHER

Dosage: 30-second 38% SDF solution application

30-second SDF application
45-second SDF applicationOTHER

Dosage: 45-second 38% SDF solution application

45-second SDF application
60-second SDF applicationOTHER

Dosage: 60-second 38% SDF solution application

60-second SDF application
120-second SDF applicationOTHER

Dosage: 120-second 38% SDF solution application

120-second SDF application
180-second SDF applicationOTHER

Dosage: 180-second 38% SDF solution application

180-second application time

Eligibility Criteria

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

You may qualify if:

  • (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.

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)

Local kindergartens

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Yan IG, Zheng FM, Sun IG, Lo ECM, Duangthip D, Chu CH. A Randomized Controlled Trial of Silver Diamine Fluoride Application Time. J Dent Res. 2025 Dec;104(13):1453-1461. doi: 10.1177/00220345251345801. Epub 2025 Jun 29.

    PMID: 40583169DERIVED

  • Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol. Trials. 2022 Mar 15;23(1):215. doi: 10.1186/s13063-022-06130-1.

    PMID: 35292085DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

October 1, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

April 28, 2026

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)