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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Anna Turska Szybka, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT02027922
First received: November 14, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
White Spot Lesion
Caries
Other: Fluor Protector S

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing the Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Deciduous Teeth in Groups at High Risk

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • the number of caries and white spot lesions in teeth treated with fluoride varnishes comparing to the control group. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: November 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Name: Duraphat Colgate
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.
Other: Fluor Protector S
Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other Name: Duraphat Colgate
No Intervention: an oral hygiene tutorial
an oral hygiene tutorial

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

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027922

Locations
Poland
Warsaw Medical University Not yet recruiting
Warsaw, Poland, 02-091
Contact: Dorota Olczak-Kowalczyk, Prof.    225022031 ext +48    do-k@o2.pl   
Principal Investigator: Dorota Olczak-Kowalczyk, Prof.         
Warsaw Medical University Recruiting
Warsaw, Poland, 02-091
Contact: Dorota Olczak-Kowalczyk, Prof    225022031 ext +48    do-k@o2.pl   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Dorota Olczak-Kowalczyk, Professor Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Anna Turska Szybka, Prof Ass., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02027922     History of Changes
Other Study ID Numbers: Clinical effectiveness of FV
Study First Received: November 14, 2013
Last Updated: January 2, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
white spot lesion
caries

Additional relevant MeSH terms:
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014