Nails and Teeth as Biomarkers of Fluoride Exposure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Different Toothpaste on Fluoride Concentration in Nails and Dental Fluorosis

Conditions
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Fluorosis, Dental

Intervention / Treatment
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* Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participation in parenting class normal pregnancy Exclusion Criteria: chronic systemic diseases genetic conditions complications at delivery

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel groups with different toothpaste fluoride concentrations (500 ppm, 1000 ppm)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 500 ppm<br>Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d) | Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)<br>* Toothpaste with 500 or 1000 ppm of fluoride<br>|
| Experimental: 1000 ppm<br>Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d) | Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)<br>* Toothpaste with 500 or 1000 ppm of fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental fluorosis | Dean index | 6 years after permanent incisor eruption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fingernails fluoride concentration | ng/mg | 4 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental fluorosis, Fingernails fluoride concentration, Fluoride toothpaste concentration