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

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).

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Key information

Conditions

White Spot Lesion Caries

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warsaw, 02-091, Poland

About this study

The study is to compare the prophylactic and therapeutic clinical effectiveness of two fluoride varnishes in children at high caries risk.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluor Protector S

Other

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

Other names: Duraphat Colgate

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Randomized Clinical Trial Comparing the Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Deciduous Teeth in Groups at High Risk

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Jan 6, 2014
Registry last updated: Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed