- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Warsaw, Poland, 02-091
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Names:
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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.
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Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Names:
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No Intervention: an oral hygiene tutorial
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group.
Time Frame: 12 months
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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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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dorota Olczak-Kowalczyk, Professor, Medical University of Warsaw
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clinical effectiveness of FV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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