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

NCT ID: NCT04274569

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2022-10-01

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.

Conditions

Early Childhood Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Sodium fluoride (NaF)

Group 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK)

Group Type: ACTIVE_COMPARATOR

NaF vanish

Intervention Type: OTHER

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.

NaF plus tricalcium phosphate (TCP )

Group 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA)

Group Type: EXPERIMENTAL

NaF-TCP

Intervention Type: OTHER

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.

NaF plus 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)

Group Type: EXPERIMENTAL

NaF-CPP-ACP

Intervention Type: OTHER

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.

Interventions

NaF vanish

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.

Intervention Type: OTHER

NaF-TCP

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.

Intervention Type: OTHER

NaF-CPP-ACP

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Grants Council, Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Cynthia Kar-Yung Yiu

Clinical Professor in Paediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

GRF Project HKU17106318

Identifier Type: -

Identifier Source: org_study_id