Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Groups at High Risk
NCT ID: NCT02027922
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2013-11-30
2016-03-31
Brief Summary
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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).
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Detailed Description
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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).
The question set bases on a Caries Assessment by Risk Management system basing on the occurrence of major caries causative agents (biological and medical), and also of the protective/preventive ones. Questions related to the social and economical status will be left out because of the difficulty of getting them answered honestly. Teeth will be scored according to International Caries Detection System II classification, and oral hygiene according to the Greene and Vermillion simplified Oral Hygiene Index (OHI-S) (1964). Children and their parents/guardians will receive hygienic, dietary and prophylactic guidelines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluoride varnish Fluor Protector S
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.
Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Duraphat
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.
Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
an oral hygiene tutorial
an oral hygiene tutorial
No interventions assigned to this group
Interventions
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Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* high risk of caries
* parent/legal guardian consent for participation in research study
Exclusion Criteria
* planned change of residence within a year
* aged \<3, \>5 years
3 Years
5 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Anna Turska Szybka
Prof Ass.
Principal Investigators
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Dorota Olczak-Kowalczyk, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Warsaw, , Poland
Countries
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References
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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.
Other Identifiers
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Clinical effectiveness of FV
Identifier Type: -
Identifier Source: org_study_id
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