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

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

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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

9

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).	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	The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility	at 6-months follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): June 30, 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 (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: preschool children; silver diamine fluoride; early childhood caries; application time
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• 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