Nails and Teeth as Biomarkers of Fluoride Exposure

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

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.

Study Overview

• Status: Completed
• Conditions: Fluorosis, Dental
• Intervention / Treatment: Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)

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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• participation in parenting class
• normal pregnancy

Exclusion Criteria:

• chronic systemic diseases
• genetic conditions
• complications at delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries in primary dentition	ICDAS	4 years of age

Collaborators and Investigators

• Sponsor: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2010
• Primary Completion (Actual): March 5, 2014
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Dental fluorosis; Fingernails fluoride concentration; Fluoride toothpaste concentration
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Stomatognathic Diseases; Tooth Diseases; Poisoning; Fluorosis, Dental; Fluoride Poisoning
• Other Study ID Numbers: NAIL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No