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

Study Overview
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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.

Official Title
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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

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Drug: 25% AgNO3 solution followed by 5% NaF varnish
* Drug: 38% SDF solution followed by placebo varnish


Participation Criteria
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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. Exclusion Criteria: Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver nitrate<br>Biannual application of 25% AgNO3 solution followed by 5% NaF varnish. | Drug: 25% AgNO3 solution followed by 5% NaF varnish<br>* Dosage of 4.4μg±1.4μg fluoride per use<br>* Other names: sodium fluoride;|
| Active Comparator: Silver diamine fluoride<br>Biannual application of 38% SDF solution followed by placebo varnish. | Drug: 38% SDF solution followed by placebo varnish<br>* Dosage of 8.8μg±2.8μg fluoride per use<br>* Other names: silver diamine fluoride;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, silver nitrate, sodium fluoride, silver diamine fluoride, non-inferiority trial