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Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish

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ClinicalTrials.gov Identifier: NCT02019160
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chun-Hung Chu, The University of Hong Kong

Brief Summary:
  • Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
  • Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
  • Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.

Condition or disease Intervention/treatment Phase
Early Childhood Caries Drug: 25% AgNO3 solution followed by 5% NaF varnish Drug: 38% SDF solution followed by placebo varnish Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1070 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial
Study Start Date : September 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silver nitrate
Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.
Drug: 25% AgNO3 solution followed by 5% NaF varnish
Dosage of 4.4μg±1.4μg fluoride per use
Other Names:
  • silver nitrate
  • sodium fluoride

Active Comparator: Silver diamine fluoride
Biannual application of 38% SDF solution followed by placebo varnish.
Drug: 38% SDF solution followed by placebo varnish
Dosage of 8.8μg±2.8μg fluoride per use
Other Name: silver diamine fluoride




Primary Outcome Measures :
  1. The hardness of cavity on tooth by probing [ Time Frame: The follow-up oral examinations will be conducted every 6 months for 30 months totally ]
    We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.

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): NCT02019160


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: Chun-Hung Chu, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02019160     History of Changes
Other Study ID Numbers: chuch14
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Chun-Hung Chu, The University of Hong Kong:
silver nitrate
sodium fluoride
silver diamine fluoride
caries
non-inferiority trial
Additional relevant MeSH terms:
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Listerine
Silver Nitrate
Pharmaceutical Solutions
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents