DNA DamageNCT05596149
Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
A study testing Toothpaste without fluoride, Toothpaste with sodium fluoride and Toothpaste with sodium monofluorophosphate in people with DNA Damage, run by University of Zagreb at 1 site in Croatia.
Trial summary
The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage
- What is being tested?
- Toothpaste without fluoride, Toothpaste with sodium fluoride and Toothpaste with sodium monofluorophosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2022to 1 Nov 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 18 and older
- good oral and general health
- non smokers
Who cannot join
- subjects suffering from infectious diseases or chronic inflammatory diseases
- use of antibiotics, corticosteroids and anti-inflammatory drugs in the last six months
- damage to the mucous membrane of the oral cavity
- subjects who have fixed-prosthetic works and orthodontic braces
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
School of Dental Medicine, University of Zagreb
Zagreb, 10000
Jasen Vladislavić, MD, +385958483757, jvladislavic4@gmail.com
About this study
The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but there are no studies examining the effect of fluoride on cells of the buccal mucosa. In vitro studies have shown that sodium fluoride can be toxic to fibroblasts of the oral mucosa by inhibiting protein synthesis, suppressing mitochondrial function and consequently reducing the amount of intracellular ATP.
The study would include 80 participants, aged between 18 and 75. All subjects would use the same toothpaste without fluoride for the first month, and then they would be randomly divided into four groups, where three groups would receive a toothpaste with fluoride with one of the active substances (sodium fluoride, sodium monofluorophosphate, amine fluoride) for the next 60 days, while the control group would continue to use the toothpaste without fluorine. Swabs of the buccal mucosa would be taken at 0 (before the start of use) and 30, 45 and 60 days after the start of using the tested toothpastes.
The aim of this research would be to examine the cytotoxic and genotoxic effect of toothpastes containing fluoride with different active substances and to compare their effect. As a measure of genotoxicity and cytotoxicity in cells, the micronucleus test will be used.
- Conditions
- DNA Damage
- Being tested
- Toothpaste without fluoride, Toothpaste with sodium fluoride, Toothpaste with sodium monofluorophosphate, Toothpaste with amine fluoride
- Keywords
- Fluoride, Toothpaste, Cytotoxicity, Genotoxicity, Buccal mucosa, DNA damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste without fluorideOther
A sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste without fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product.
Toothpaste with sodium fluorideOther
A sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with sodium fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product.
Toothpaste with sodium monofluorophosphateOther
A sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with sodium monofluorophosphate and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product.
Toothpaste with amine fluorideOther
A sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with amine fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product.
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste without fluoride | Active comparator | A group of participants that will be using toothpaste without fluoride. Receives: Other: Toothpaste without fluoride |
| Toothpaste with sodium fluoride | Experimental | A group of participants that will be using toothpaste with sodium fluoride. Receives: Other: Toothpaste with sodium fluoride |
| Toothpaste with sodium monofluorophosphate | Experimental | A group of participants that will be using toothpaste with sodium monofluorophosphate. Receives: Other: Toothpaste with sodium monofluorophosphate |
| Toothpaste with amine fluoride | Experimental | A group of participants that will be using toothpaste with amine fluoride. Receives: Other: Toothpaste with amine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with cytotoxic and genotoxic effect of fluoridated toothpastes in buccal cells, assessed by micronucleus test
The micronucleus test is used to determine whether a compound is genotoxic by assessing the presence of micronuclei. Micronuclei can originate from chromosome fragments or whole chromosomes that cannot migrate to the poles during the anaphase phase of cell division. This test is widely used for monitoring buccal cells because of its precision for detecting chromosomal damage. The cells of the buccal mucosa will be taken with a cytological brush, the cell suspension is centrifuged, then applied to a microscope slide and fixed with methanol. The slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA DamageStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University of Split, School of Medicine
- Responsible party
- Principal investigator, Jasen Vladislavić, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596149
- Sponsor's protocol ID
- 2181-198-03-04-22-0003
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
- ClinicalTrials.gov ID
- NCT05596149
- Acronym / sponsor ID
- 2181-198-03-04-22-0003
- Conditions
- DNA Damage
- Keywords
- Fluoride, Toothpaste, Cytotoxicity, Genotoxicity, Buccal mucosa, DNA damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- University of Split, School of Medicine
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Oct 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.
The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but there are no studies examining the effect of fluoride on cells of the buccal mucosa. In vitro studies have shown that sodium fluoride can be toxic to fibroblasts of the oral mucosa by inhibiting protein synthesis, suppressing mitochondrial function and consequently reducing the amount of intracellular ATP.
The study would include 80 participants, aged between 18 and 75. All subjects would use the same toothpaste without fluoride for the first month, and then they would be randomly divided into four groups, where three groups would receive a toothpaste with fluoride with one of the active substances (sodium fluoride, sodium monofluorophosphate, amine fluoride) for the next 60 days, while the control group would continue to use the toothpaste without fluorine. Swabs of the buccal mucosa would be taken at 0 (before the start of use) and 30, 45 and 60 days after the start of using the tested toothpastes.
The aim of this research would be to examine the cytotoxic and genotoxic effect of toothpastes containing fluoride with different active substances and to compare their effect. As a measure of genotoxicity and cytotoxicity in cells, the micronucleus test will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Toothpaste without fluoride | Active comparator | Other: Toothpaste without fluorideA group of participants that will be using toothpaste without fluoride. |
| Toothpaste with sodium fluoride | Experimental | Other: Toothpaste with sodium fluorideA group of participants that will be using toothpaste with sodium fluoride. |
| Toothpaste with sodium monofluorophosphate | Experimental | Other: Toothpaste with sodium monofluorophosphateA group of participants that will be using toothpaste with sodium monofluorophosphate. |
| Toothpaste with amine fluoride | Experimental | Other: Toothpaste with amine fluorideA group of participants that will be using toothpaste with amine fluoride. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of 18 and older
- good oral and general health
- non smokers
Key exclusion criteria (4 listed)
- subjects suffering from infectious diseases or chronic inflammatory diseases
- use of antibiotics, corticosteroids and anti-inflammatory drugs in the last six months
- damage to the mucous membrane of the oral cavity
- subjects who have fixed-prosthetic works and orthodontic braces
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 |
|---|---|---|
| Toothpaste without fluorideA sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste without fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product. | Other | Toothpaste without fluoride |
| Toothpaste with sodium fluorideA sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with sodium fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product. | Other | Toothpaste with sodium fluoride |
| Toothpaste with sodium monofluorophosphateA sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with sodium monofluorophosphate and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product. | Other | Toothpaste with sodium monofluorophosphate |
| Toothpaste with amine fluorideA sample of cells from the area of the buccal mucosa of each of the subjects will be taken with a cytological brush just before the start of using the toothpaste with amine fluoride and 30, 45 and 60 days after the start of use. Cell suspension is applied on a microscopy slide. Slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope. After using each tested toothpaste, the respondents will be given a specially designed questionnaire with questions related to their opinion about the used oral hygiene product. | Other | Toothpaste with amine fluoride |
Primary outcome
Number of patients with cytotoxic and genotoxic effect of fluoridated toothpastes in buccal cells, assessed by micronucleus test
Time frame: 90 days
The micronucleus test is used to determine whether a compound is genotoxic by assessing the presence of micronuclei. Micronuclei can originate from chromosome fragments or whole chromosomes that cannot migrate to the poles during the anaphase phase of cell division. This test is widely used for monitoring buccal cells because of its precision for detecting chromosomal damage. The cells of the buccal mucosa will be taken with a cytological brush, the cell suspension is centrifuged, then applied to a microscope slide and fixed with methanol. The slides will be stained with Fast Green FCF dye and analyzed with an epifluorescence microscope.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste without fluoride, Toothpaste with sodium fluoride and Toothpaste with sodium monofluorophosphate in people with DNA Damage, run by University of Zagreb at 1 site in Croatia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with cytotoxic and genotoxic effect of fluoridated toothpastes in buccal cells, assessed by micronucleus test (time frame: 90 days). 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 27 Oct 2022.