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Effectiveness of SDF in Arresting Dental Caries in Preschool Children

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02385474
Enrollment
888
Registered
2015-03-11
Start date
2013-03-31
Completion date
Unknown
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Caries

Keywords

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

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.

Interventions

DRUG12% SDF

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

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up30-month follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026