Effect of Three Types of Fluoride Varnish in Preventing Early Childhood Caries

Study Overview
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Brief Summary
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This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.

Detailed Description
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Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization. However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes. The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.

Official Title
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Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Other: NaF vanish
* Other: NaF-TCP
* Other: NaF-CPP-ACP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children. Exclusion Criteria: Patients who had received professional fluoride application in the past 6 months Patients with underlying medical history or special health care needs Patient who are uncooperative or refuse the treatment Patient who are allergic to milk protein (as MI VarnishTM contains casein, a milk protein) Patient with contraindication for fluoride varnish e.g. hypersensitivity to colophony and/or any other constituents Patient who have primary teeth with enamel hypoplasia

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium fluoride (NaF)<br>Group 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK) | Other: NaF vanish<br>* A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.<br>|
| Experimental: NaF plus tricalcium phosphate (TCP )<br>Group 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA) | Other: NaF-TCP<br>* A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.<br>|
| Experimental: NaF plus CPP-ACP<br>Group 3: Quarterly application of a 5% NaF plus casein phosphopeptide-stabilized amorphous calcium phosphate complexes (CPP-ACP) (MI Varnish TM; GC corporation, Itabashi-Ku, Tokyo, Japan) | Other: NaF-CPP-ACP<br>* A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with new caries and new dmfs. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS growth | Quantity of mutans streptococcus (MS) measured by quantitative polymerase chain reaction (qPCR) | 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries, Fluoride vanish, Calcium phosphate, Randomised clinical trial, Remineralisation