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Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Groups at High Risk

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ClinicalTrials.gov Identifier: NCT02027922
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Turska Szybka, Medical University of Warsaw

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).


Condition or disease Intervention/treatment Phase
White Spot Lesion Caries Other: Fluor Protector S Not Applicable

Detailed Description:

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).

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing the Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Deciduous Teeth in Groups at High Risk
Actual Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: 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.
Other: Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Name: Duraphat Colgate

Active Comparator: 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.
Other: Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Name: Duraphat Colgate

No Intervention: an oral hygiene tutorial
an oral hygiene tutorial



Primary Outcome Measures :
  1. the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group. [ Time Frame: 12 months ]
    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)



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027922


Locations
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Poland
Warsaw, Poland, 02-091
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Dorota Olczak-Kowalczyk, Professor Medical University of Warsaw

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Responsible Party: Anna Turska Szybka, Prof Ass., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02027922     History of Changes
Other Study ID Numbers: Clinical effectiveness of FV
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Keywords provided by Anna Turska Szybka, Medical University of Warsaw:
white spot lesion
caries

Additional relevant MeSH terms:
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Fluorides
Fluorides, Topical
Sodium fluoride topical preparation
Sodium Fluoride
Listerine
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents