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Completed

NCT Number: NCT02019160

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

* 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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

25% AgNO3 solution followed by 5% NaF varnish

Drug

Dosage of 4.4μg±1.4μg fluoride per use

Other names: silver nitrate, sodium fluoride

38% SDF solution followed by placebo varnish

Drug

Dosage of 8.8μg±2.8μg fluoride per use

Other names: silver diamine fluoride

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2013
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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