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Trial record 52 of 1201 for:    tooth decay

Effectiveness of SDF in Arresting Dental Caries in Preschool Children

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ClinicalTrials.gov Identifier: NCT02385474
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Early Childhood Caries Drug: 12% SDF Drug: 38% SDF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 888 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Preschool Children: a Randomized Clinical Trial With Different Periodicity and Concentration.
Study Start Date : March 2013
Actual Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 12% silver diamine fluoride




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385474


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Chun Hung Chu The University of Hong Kong

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02385474     History of Changes
Other Study ID Numbers: HKU765213M
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by The University of Hong Kong:
silver diamine fluoride
randomized clinical trial
caries
children
fluoride

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs