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

University of Zagreb

Status: Enrolling

Conditions: DNA Damage

Treatments: Other: Toothpaste with sodium monofluorophosphate; Other: Toothpaste with sodium fluoride; Other: Toothpaste with amine fluoride; Other: Toothpaste without fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT05596149

2181-198-03-04-22-0003

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Toothpaste without fluoride

Active Comparator group

Description:

A group of participants that will be using toothpaste without fluoride.

Treatment:

Other: Toothpaste without fluoride

Toothpaste with sodium fluoride

Experimental group

Description:

A group of participants that will be using toothpaste with sodium fluoride.

Treatment:

Other: Toothpaste with sodium fluoride

Toothpaste with sodium monofluorophosphate

Experimental group

Description:

A group of participants that will be using toothpaste with sodium monofluorophosphate.

Treatment:

Other: Toothpaste with sodium monofluorophosphate

Toothpaste with amine fluoride

Experimental group

Description:

A group of participants that will be using toothpaste with amine fluoride.

Treatment:

Other: Toothpaste with amine fluoride