Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
NCT ID: NCT05596149
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-11-01
2023-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Toothpaste without fluoride
A group of participants that will be using toothpaste without fluoride.
Toothpaste without fluoride
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 fluoride
A group of participants that will be using toothpaste with sodium fluoride.
Toothpaste with sodium fluoride
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 monofluorophosphate
A group of participants that will be using toothpaste with sodium monofluorophosphate.
Toothpaste with sodium monofluorophosphate
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 fluoride
A group of participants that will be using toothpaste with amine fluoride.
Toothpaste with amine fluoride
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.
Interventions
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Toothpaste without fluoride
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 fluoride
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 monofluorophosphate
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 fluoride
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.
Eligibility Criteria
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Inclusion Criteria
* good oral and general health
* non smokers
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University of Split, School of Medicine
OTHER
University of Zagreb
OTHER
Responsible Party
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Jasen Vladislavić
Pulmonology Resident, Medical Doctor
Locations
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School of Dental Medicine, University of Zagreb
Zagreb, , Croatia
Countries
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Facility Contacts
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Other Identifiers
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2181-198-03-04-22-0003
Identifier Type: -
Identifier Source: org_study_id
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