NCT02027922

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• White Spot Lesion
• Caries

Interventions

Type	Name	Description
OTHER	Fluor Protector S	Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2014-01-06
• Last updated: 2019-07-18

Locations

1 site across 1 country: Poland