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

Not Applicable

• Conditions: Early Childhood Caries
• Interventions: Other: NaF-CPP-ACP; Other: NaF vanish; Other: NaF-TCP

• Registration Number: NCT04274569
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-03-13
• Study First Submitted: 2019-11-12
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Primary Completion: 2021-07-15
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 570

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaF plus CPP-ACP	NaF-CPP-ACP	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)
Sodium fluoride (NaF)	NaF vanish	Group 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK)
NaF plus tricalcium phosphate (TCP )	NaF-TCP	Group 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA)

Primary Outcome Measures

Name	Time	Method
Proportion of children with new caries and new dmfs.	24 months

Secondary Outcome Measures

Name	Time	Method
MS growth	12 months and 24 months	Quantity of mutans streptococcus (MS) measured by quantitative polymerase chain reaction (qPCR)

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong