Effectiveness of SDF in Arresting Dental Caries in Preschool Children

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385474
• Other study ID #: HKU765213M
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2015
• Last updated: May 12, 2016
• Start date: March 2013

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 888
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 4 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Early Childhood Caries

Intervention

Drug:
• 12% SDF
12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure
• 38% SDF
38% silver diamine fluoride solution, of which the capability of arresting dental caries is known

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up		30-month follow-up	No