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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027922
• Other study ID #: Clinical effectiveness of FV
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2019
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Dental Caries
• White Spot Lesion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group.	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)	12 months