Effectiveness of SDF in Arresting Dental Caries in Preschool Children

May 12, 2016 updated by: The University of Hong Kong

Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Preschool Children: a Randomized Clinical Trial With Different Periodicity and Concentration.

Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. Conventional dental care for ECC is neither affordable nor accessible, particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe, cost-effective caries-arresting agent that appears to conform to the World Health Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an evidence base. Therefore it is necessary to find the most suitable SDF concentration and application interval to arrest ECC. The purpose of this randomised controlled trial is to compare the efficacy of two commercially available SDF solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth.

Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. The sample size is sufficient for the appropriate statistical analyses. The children were classified into high and low caries rates and equally allocated into four groups for the caries treatment:

Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children will be followed for 36 months in their kindergartens until they enter primary school. Clinical examinations at 6-month intervals will be conducted to assess whether the caries are 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 follow-ups.

Discussion: This study will help determine the most suitable SDF concentration and application interval to arrest caries in children. Because SDF use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. The applicability of the findings and their impact on public health would be immense.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

888

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The children included in the study should

  1. aged 3-4 years who have tooth decay and are attending the first year of kindergarten,
  2. be generally healthy,
  3. have parental consent, and
  4. have at least 1 tooth with untreated caries that extends into the dentine.

Exclusion Criteria:

  • Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 38% SDF semi-annual
semi-annual application of 38% SDF
Drug: 38% SDF
38% silver diamine fluoride solution, of which the capability of arresting dental caries is known
Other Names:
  • 38% silver diamine fluoride
Experimental: 38% SDF annual
annual application of 38% SDF
Drug: 38% SDF
38% silver diamine fluoride solution, of which the capability of arresting dental caries is known
Other Names:
  • 38% silver diamine fluoride
Active Comparator: 12% SDF semi-annual
semi-annual application of 12% SDF
Drug: 12% SDF
12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure
Other Names:
  • 12% silver diamine fluoride
Active Comparator: 12% SDF annual
annual application of 12% SDF
Drug: 12% SDF
12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure
Other Names:
  • 12% silver diamine fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up
Time Frame: 30-month follow-up
30-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Chun Hung Chu, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU765213M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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