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
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
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
NCT ID
NCT05442320
First Posted
December 3, 2021
Last Updated
June 29, 2022
Sponsor
University of Ljubljana
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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