Preventing Early Childhood Caries With Silver Diamine Fluoride

Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial

Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth.

Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds.

Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Device: silver diamine fluoride; Device: sodium fluoride

• Study Type: Interventional
• Enrollment (Anticipated): 730
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chun Hung Chu, PhD; Phone Number: (+852)28590287; Email: chchu@hku.hk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• generally healthy, with parental consents

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: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silver diamine fluoride; 38% silver diamine fluoride	Device: silver diamine fluoride; 38% SDF on primary upper anterior teeth
Active Comparator: sodium fluoride; 5% sodium fluoride	Device: sodium fluoride; 5% NaF on primary upper anterior teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caries prevention	the number of sound tooth surfaces that become cavitated caries per child	at 30-month follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• Gao SS, Chen KJ, Duangthip D, Wong MCM, Lo ECM, Chu CH. Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. Trials. 2020 Feb 4;21(1):140. doi: 10.1186/s13063-020-4088-7.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: UW18-619

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: Yes
• product manufactured in and exported from the U.S.: Yes