MedTrace Logo

Efficacy of Fluor Protector S in the Prevention in Adolescents

NCT03720379 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-06-27

No results posted yet for this study

Summary

Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.

In this study, half of the randomly assigned participants will received fluoride varnish (Fluor Protector S) and will be considered an intervention group. The other half will undergo placebo application.

Conditions

  • Dental Caries
  • Fluor

Interventions

DEVICE

Fluor Protector S

. All of the elements of a clinical trial and the varnish applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.

DEVICE

Placebo

All of the elements of a clinical trial and the placebo applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.

Sponsors & Collaborators

  • Ivoclar Vivadent AG

    collaborator INDUSTRY

  • Wroclaw Medical University

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Dorota Olczak Kowalczyk, PROFESSOR · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-19
Primary Completion
2020-01-31
Completion
2020-05-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720379 on ClinicalTrials.gov