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Trial record 31 of 291 for:    Sodium Fluoride OR Duraphat

Preventing Early Childhood Caries With Silver Diamine Fluoride

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ClinicalTrials.gov Identifier: NCT04075474
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chun-Hung Chu, The University of Hong Kong

Brief Summary:

Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth.

Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds.

Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.


Condition or disease Intervention/treatment Phase
Dental Caries Device: silver diamine fluoride Device: sodium fluoride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: silver diamine fluoride
38% silver diamine fluoride
Device: silver diamine fluoride
38% SDF on primary upper anterior teeth

Active Comparator: sodium fluoride
5% sodium fluoride
Device: sodium fluoride
5% NaF on primary upper anterior teeth




Primary Outcome Measures :
  1. caries prevention [ Time Frame: at 30-month follow-up ]
    the number of sound tooth surfaces that become cavitated caries per child



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Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy, with parental consents

Exclusion Criteria:

  • uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

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): NCT04075474


Contacts
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Contact: Chun Hung Chu, PhD (+852)28590287 chchu@hku.hk

Locations
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Hong Kong
Local kindergartens Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Chun-Hung Chu, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04075474     History of Changes
Other Study ID Numbers: UW18-619
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents