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

NCT ID: NCT03423797

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NaF without fTCP

25% AgNO3 solution followed by 5% NaF.

Group Type ACTIVE_COMPARATOR

25% AgNO3 solution followed by 5% NaF

Intervention Type DRUG

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

NaF with fTCP

25% AgNO3 solution followed by 5% NaF with fTCP.

Group Type EXPERIMENTAL

25% AgNO3 solution followed by 5% NaF with fTCP

Intervention Type DRUG

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

Interventions

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25% AgNO3 solution followed by 5% NaF

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

Intervention Type DRUG

25% AgNO3 solution followed by 5% NaF with fTCP

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

Intervention Type DRUG

Other Intervention Names

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5% NaF without fTCP 5% NaF with fTCP

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chun-Hung Chu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Hung Chu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

References

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Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate. J Dent Res. 2021 Jan;100(1):66-73. doi: 10.1177/0022034520952031. Epub 2020 Aug 31.

Reference Type DERIVED
PMID: 32866050 (View on PubMed)

Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial. Trials. 2018 Jul 4;19(1):352. doi: 10.1186/s13063-018-2741-1.

Reference Type DERIVED
PMID: 29973256 (View on PubMed)

Other Identifiers

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UW 17-176

Identifier Type: -

Identifier Source: org_study_id