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Nails and Teeth as Biomarkers of Fluoride Exposure

Primary Purpose

Fluorosis, Dental

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fluorosis, Dental focused on measuring Dental fluorosis, Fingernails fluoride concentration, Fluoride toothpaste concentration

Eligibility Criteria

0 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participation in parenting class
  • normal pregnancy

Exclusion Criteria:

  • chronic systemic diseases
  • genetic conditions
  • complications at delivery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    500 ppm

    1000 ppm

    Arm Description

    Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d)

    Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d)

    Outcomes

    Primary Outcome Measures

    Dental fluorosis
    Dean index

    Secondary Outcome Measures

    Fingernails fluoride concentration
    ng/mg

    Full Information

    First Posted
    December 3, 2021
    Last Updated
    June 29, 2022
    Sponsor
    University of Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05442320
    Brief Title
    Nails and Teeth as Biomarkers of Fluoride Exposure
    Official Title
    Influence of Different Toothpaste on Fluoride Concentration in Nails and Dental Fluorosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2010 (Actual)
    Primary Completion Date
    March 5, 2014 (Actual)
    Study Completion Date
    April 20, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.
    Detailed Description
    Toothpaste with 1000 ppm fluoride and above are more effective in a caries prevention in comparison to toothpastes with lower fluoride concentration or to placebo. Higher fluoride concentrations in toothpastes increase risk for development of tooth fluorosis. Children in first three years of life are most susceptible due to formation of permanent incisors and first molars in this period, beside younger children ingest more toothpaste compared to older children. Fluoride exposure can be measured in nails, where the average plasma fluoride concentration is reflected. The aim of our study was to determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In our study were included parents and children who had participated in previous studies from parenting class until children's 3 years of age. At that time children were randomly assigned to one of two groups, of which one was being given a toothpaste with 500 ppm fluoride and the other with 1000 ppm fluoride. Children were examined regularly until the age of 3. Children were invited to participate in another clinical examination at 4 years of age. At the time of examination parents were asked to fulfil a questionnaire about oral hygiene habits and a sample of children's fingernails were taken. A questionnaire fulfilled 200 parents, 169 children were examined, finger nail fluoride was analysed by using a gas chromatography method in 161 children. We determined that in 76 % the toothpaste chosen was not appropriate according to EAPD guidelines, 66 % parents was using toothpaste with 500 ppm fluoride for their children. The mean fingernail concentration was 1,43 ng/mg (SD = 0,08). The difference between groups using toothpastes with different fluoride concentrations, and compared with other factors, was not statistically significant. The mean concentration of fluoride in nails of our test group was low compared to reported values in similar studies and there was no significant difference between groups regarding to toothpaste used. In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fluorosis, Dental
    Keywords
    Dental fluorosis, Fingernails fluoride concentration, Fluoride toothpaste concentration

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two parallel groups with different toothpaste fluoride concentrations (500 ppm, 1000 ppm)
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Same packages of toothpastes with different concentration Key known only to principal investigator
    Allocation
    Randomized
    Enrollment
    342 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    500 ppm
    Arm Type
    Active Comparator
    Arm Description
    Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d)
    Arm Title
    1000 ppm
    Arm Type
    Experimental
    Arm Description
    Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d)
    Intervention Type
    Device
    Intervention Name(s)
    Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)
    Intervention Description
    Toothpaste with 500 or 1000 ppm of fluoride
    Primary Outcome Measure Information:
    Title
    Dental fluorosis
    Description
    Dean index
    Time Frame
    6 years after permanent incisor eruption
    Secondary Outcome Measure Information:
    Title
    Fingernails fluoride concentration
    Description
    ng/mg
    Time Frame
    4 years of age
    Other Pre-specified Outcome Measures:
    Title
    Caries in primary dentition
    Description
    ICDAS
    Time Frame
    4 years of age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: participation in parenting class normal pregnancy Exclusion Criteria: chronic systemic diseases genetic conditions complications at delivery

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Nails and Teeth as Biomarkers of Fluoride Exposure

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