Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05442320 |
| Other study ID # |
NAIL1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2010 |
| Est. completion date |
April 20, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
University of Ljubljana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
