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

NCT04274569 | Unknown

• 1 other identifier: GRF Project HKU17106318
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Caries; Fluoride vanish; Calcium phosphate; Randomised clinical trial; Remineralisation

Outcome Measures

Primary Outcomes (1)

• Proportion of children with new caries and new dmfs.

  24 months

Secondary Outcomes (1)

• MS growth

  12 months and 24 months

Study Arms (3)

Sodium fluoride (NaF)

ACTIVE COMPARATOR

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

Other: NaF vanish

NaF plus tricalcium phosphate (TCP )

EXPERIMENTAL

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

Other: NaF-TCP

NaF plus CPP-ACP

EXPERIMENTAL

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

Interventions

NaF vanish 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.

Sodium fluoride (NaF)

NaF-TCP 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 )

NaF-CPP-ACP 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

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, 999077, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Paediatric Dentistry

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: February 18, 2020
• Study Start: March 13, 2019
• Primary Completion: July 15, 2021
• Study Completion: October 1, 2022
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)