Clinical trial NCT02027922: Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Groups at High Risk
Official title: Randomized Clinical Trial Comparing the Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Deciduous Teeth in Groups at High Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Caries
Keywords: white spot lesion
caries
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
Study officials:
affiliation: Medical University of Warsaw
name: Dorota Olczak-Kowalczyk, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.