Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa

October 23, 2022 updated by: Jasen Vladislavić, University of Zagreb

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • School of Dental Medicine, University of Zagreb
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age of 18 and older
  • good oral and general health
  • non smokers

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Toothpaste without fluoride
A group of participants that will be using toothpaste without fluoride.
Other: 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.
Experimental: Toothpaste with sodium fluoride
A group of participants that will be using toothpaste with sodium fluoride.
Other: 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.
Experimental: Toothpaste with sodium monofluorophosphate
A group of participants that will be using toothpaste with sodium monofluorophosphate.
Other: 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.
Experimental: Toothpaste with amine fluoride
A group of participants that will be using toothpaste with amine fluoride.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zagreb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Split, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2181-198-03-04-22-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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