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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04655430

Enrollment

665

Registered

2020-12-07

Start date

2021-10-01

Completion date

2022-07-31

Last updated

2026-06-15

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

Conditions

Early Childhood Caries

Keywords

silver diamine fluoride, application time, preschool children, early childhood caries

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.

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 carious teeth were block-randomized into 9 groups with SDF application times of 3, 5, 10, 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.

Interventions

OTHER3-second SDF application

Dosage: 3-second 38% SDF solution application

OTHER5-second SDF application

Dosage: 5-second 38% SDF solution application

OTHER10-second SDF application

Dosage: 10-second 38% SDF solution application

OTHER15-second SDF application

Dosage: 15-second 38% SDF solution application

OTHER30-second SDF application

Dosage: 30-second 38% SDF solution application

OTHER45-second SDF application

Dosage: 45-second 38% SDF solution application

OTHER60-second SDF application

Dosage: 60-second 38% SDF solution application

OTHER120-second SDF application

Dosage: 120-second 38% SDF solution application

OTHER180-second SDF application

Dosage: 180-second 38% SDF solution application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 5 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Status of Caries Arrest (Surface Hardness)	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).
dmft index	at 6-months follow-up	The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility
The visible plaque index (VPI).	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.

Secondary

Measure	Time frame	Description
Clinical Presentation of Lesion Coloration	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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026