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

Phase 2

Completed

• Conditions: Early Childhood Caries
• Interventions: Other: 10-second SDF application; Other: 3-second SDF application; Other: 5-second SDF application; Other: 60-second SDF application; Other: 15-second SDF application; Other: 30-second SDF application; Other: 45-second SDF application; Other: 180-second SDF application; Other: 120-second SDF application

• Registration Number: NCT04655430
• Lead Sponsor: The University of Hong Kong

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 414 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. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2021-10-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-second SDF application	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.
3-second SDF application	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.
5-second SDF application	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.
60-second SDF application	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.
15-second SDF application	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.
30-second SDF application	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.
45-second SDF application	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.
180-second application time	180-second SDF application	180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
120-second SDF application	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Local kindergartens; 🇭🇰 Hong Kong, Hong Kong