Effectiveness of SDF in Arresting Dental Caries in Preschool Children

NCT02385474 | Completed Phase 3

• 1 other identifier: HKU765213M
• Study Type: interventional
• Target: 888
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries

Keywords

silver diamine fluoride; randomized clinical trial; caries; children; fluoride

Outcome Measures

Primary Outcomes (1)

• change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up

  30-month follow-up

Study Arms (4)

38% SDF semi-annual

EXPERIMENTAL

semi-annual application of 38% SDF

Drug: 38% SDF

38% SDF annual

EXPERIMENTAL

annual application of 38% SDF

Drug: 38% SDF

12% SDF semi-annual

ACTIVE COMPARATOR

semi-annual application of 12% SDF

Drug: 12% SDF

12% SDF annual

ACTIVE COMPARATOR

annual application of 12% SDF

Drug: 12% SDF

Interventions

12% SDF DRUG

12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure

Also known as: 12% silver diamine fluoride

12% SDF annual; 12% SDF semi-annual

38% SDF DRUG

38% silver diamine fluoride solution, of which the capability of arresting dental caries is known

Also known as: 38% silver diamine fluoride

38% SDF annual; 38% SDF semi-annual

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (6)

• Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.

  PMID: 19341576 BACKGROUND

• Chu CH, Fung DS, Lo EC. Dental caries status of preschool children in Hong Kong. Br Dent J. 1999 Dec 11;187(11):616-20; discussion 605. doi: 10.1038/sj.bdj.4800347.

  PMID: 16163284 BACKGROUND

• Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.

  PMID: 12407092 BACKGROUND

• Lo EC, Chu CH, Lin HC. A community-based caries control program for pre-school children using topical fluorides: 18-month results. J Dent Res. 2001 Dec;80(12):2071-4. doi: 10.1177/00220345010800120901.

  PMID: 11808764 BACKGROUND

• Duangthip D, Fung MHT, Wong MCM, Chu CH, Lo ECM. Adverse Effects of Silver Diamine Fluoride Treatment among Preschool Children. J Dent Res. 2018 Apr;97(4):395-401. doi: 10.1177/0022034517746678. Epub 2017 Dec 13.

  PMID: 29237131 DERIVED

• Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Clinical Trial of 12% and 38% Silver Diamine Fluoride Treatment. J Dent Res. 2018 Feb;97(2):171-178. doi: 10.1177/0022034517728496. Epub 2017 Aug 28.

  PMID: 28846469 DERIVED

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• Chun Hung Chu

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 11, 2015
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

CN (1)