Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
1 other identifier
interventional
80
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedOctober 27, 2022
October 1, 2022
3 months
October 4, 2022
October 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 days
Study Arms (4)
Toothpaste without fluoride
ACTIVE COMPARATORA group of participants that will be using toothpaste without fluoride.
Toothpaste with sodium fluoride
EXPERIMENTALA group of participants that will be using toothpaste with sodium fluoride.
Toothpaste with sodium monofluorophosphate
EXPERIMENTALA group of participants that will be using toothpaste with sodium monofluorophosphate.
Toothpaste with amine fluoride
EXPERIMENTALA group of participants that will be using toothpaste with amine fluoride.
Interventions
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.
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.
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.
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
You may qualify if:
- age of 18 and older
- good oral and general health
- non smokers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zagreblead
- University of Split, School of Medicinecollaborator
Study Sites (1)
School of Dental Medicine, University of Zagreb
Zagreb, 10000, Croatia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pulmonology Resident, Medical Doctor
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 27, 2022
Study Start
November 1, 2022
Primary Completion
February 1, 2023
Study Completion
November 1, 2023
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share