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Completed

NCT Number: NCT03423797

The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children

The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.

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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

About this study

Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children.

Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. 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 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). 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 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have at least one tooth with cavitated dentine carious lesion

Exclusion criteria

  • Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.

Treatment and study plan

25% AgNO3 solution followed by 5% NaF

Drug

Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).

Other names: 5% NaF without fTCP

25% AgNO3 solution followed by 5% NaF with fTCP

Drug

Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).

Other names: 5% NaF with fTCP

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

    The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.

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 With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Nov 4, 2020

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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