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

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

1070 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-06-30

Brief Summary

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* 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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Detailed Description

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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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Silver nitrate

Biannual application of 25% AgNO3 solution followed by 5% NaF varnish.

Group Type EXPERIMENTAL

25% AgNO3 solution followed by 5% NaF varnish

Intervention Type DRUG

Dosage of 4.4μg±1.4μg fluoride per use

Silver diamine fluoride

Biannual application of 38% SDF solution followed by placebo varnish.

Group Type ACTIVE_COMPARATOR

38% SDF solution followed by placebo varnish

Intervention Type DRUG

Dosage of 8.8μg±2.8μg fluoride per use

Interventions

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25% AgNO3 solution followed by 5% NaF varnish

Dosage of 4.4μg±1.4μg fluoride per use

Intervention Type DRUG

38% SDF solution followed by placebo varnish

Dosage of 8.8μg±2.8μg fluoride per use

Intervention Type DRUG

Other Intervention Names

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silver nitrate sodium fluoride silver diamine fluoride

Eligibility Criteria

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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.