Fluorosis, DentalNCT05442320
Nails and Teeth as Biomarkers of Fluoride Exposure
A study testing Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia) in people with Fluorosis, Dental, run by University of Ljubljana.
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. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Fluorosis, Dental
- What is being tested?
- Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2010to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- participation in parenting class
- normal pregnancy
Who cannot join
- chronic systemic diseases
- genetic conditions
- complications at delivery
About this study
Official title: 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.
Read the 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.
- Conditions
- Fluorosis, Dental
- Being tested
- Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)
- Keywords
- Dental fluorosis, Fingernails fluoride concentration, Fluoride toothpaste concentration
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)Device
Toothpaste with 500 or 1000 ppm of fluoride
| Study group | Role | What they receive |
|---|---|---|
| 500 ppm | Active comparator | Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d) Receives: Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia) |
| 1000 ppm | Experimental | Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d) Receives: Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental fluorosis
Dean index
Measured: 6 years after permanent incisor eruption
Secondary outcomes (1)
Fingernails fluoride concentration
ng/mg
Measured: 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start3 Jan 2010
- Primary completion5 Mar 2014
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorosis, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups with different toothpaste fluoride concentrations (500 ppm, 1000 ppm)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442320
- Sponsor's protocol ID
- NAIL1
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Toothpaste on Fluoride Concentration in Nails and Dental Fluorosis
- ClinicalTrials.gov ID
- NCT05442320
- Acronym / sponsor ID
- NAIL1
- Conditions
- Fluorosis, Dental
- Keywords
- Dental fluorosis, Fingernails fluoride concentration, Fluoride toothpaste concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 3 Jan 2010 (actual)
- Primary completion
- 5 Mar 2014 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups with different toothpaste fluoride concentrations (500 ppm, 1000 ppm)
| Arm | Type | Receives |
|---|---|---|
| 500 ppm | Active comparator | Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d) |
| 1000 ppm | Experimental | Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d) |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- participation in parenting class
- normal pregnancy
Key exclusion criteria (3 listed)
- chronic systemic diseases
- genetic conditions
- complications at delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)Toothpaste with 500 or 1000 ppm of fluoride | Device | 1000 ppm, 500 ppm |
Primary outcome
Dental fluorosis
Time frame: 6 years after permanent incisor eruption
Dean index
1 secondary outcome
Fingernails fluoride concentration
Time frame: 4 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia) in people with Fluorosis, Dental, run by University of Ljubljana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental fluorosis (time frame: 6 years after permanent incisor eruption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.