NCT02027922

Brief Summary

The study is to compare the prophylactic and therapeutic clinical effectiveness of two fluoride varnishes in children at high caries risk. It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly to what occurs after the use of Duraphat varnish (C).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

November 14, 2013

Last Update Submit

July 15, 2019

Conditions

White Spot LesionCaries

Keywords

white spot lesioncaries

Outcome Measures

Primary Outcomes (1)

  • the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group.

    The primary outcome were caries prevalence and increment.The primary endpoint for each individual child is whether or not there has been any occurrence of new caries lesions over the 1 year period, as measured by any increase in d3mft at 1 years of follow up compared to the d3mft at baseline (d3mft is dental decay as measured by the dmft scale in the dentine)

    12 months

Study Arms (3)

Fluoride varnish Fluor Protector S

EXPERIMENTAL

Fluoride varnish Fluor Protector S (Ivoclar Vivadent) with 1.5% ammonium fluoride was not scored. The emergence of a new varnish implies the necessity to compare the effectiveness of both agents in preventing caries in deciduous teeth. All of the elements of a clinical trial and the varnish applications will be performed four times at three-month intervals: examination - 0 (initial score), follow-ups to the initial examination and intervention: 1 - after 3 months, 2 - after 6 months, 3 - after 9 months. Changes in OHI-S, spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs, and their components will be scored at follow-up examinations.

Other: Fluor Protector S

Duraphat

ACTIVE COMPARATOR

5% Sodium fluoride varnish Duraphat Colgate implies the necessity to compare the effectiveness with Fluor Protector S in preventing caries in deciduous teeth. All of the elements of a clinical trial and the varnish applications will be performed four times at three-month intervals: examination - 0 (initial score), follow-ups to the initial examination and intervention: 1 - after 3 months, 2 - after 6 months, 3 - after 9 months. Changes in OHI-S, spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs, and their components will be scored at follow-up examinations.

Other: Fluor Protector S

an oral hygiene tutorial

NO INTERVENTION

an oral hygiene tutorial

Interventions

Fluor Protector SOTHER

Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)

Also known as: Duraphat Colgate
DuraphatFluoride varnish Fluor Protector S

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • generally healthy children aged 3-5 years
  • high risk of caries
  • parent/legal guardian consent for participation in research study

You may not qualify if:

  • chronic diseases or medication in medical history
  • planned change of residence within a year
  • aged \<3, \>5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Warsaw, 02-091, Poland

Location

Related Publications (1)

  • Turska-Szybka A, Gozdowski D, Twetman S, Olczak-Kowalczyk D. Clinical Effect of Two Fluoride Varnishes in Caries-Active Preschool Children: A Randomized Controlled Trial. Caries Res. 2021;55(2):137-143. doi: 10.1159/000514168. Epub 2021 Mar 11.

    PMID: 33706305DERIVED

Study Officials

  • Dorota Olczak-Kowalczyk, Professor

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Ass.

Study Record Dates

First Submitted

November 14, 2013

First Posted

January 6, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

PL(1)