In Vivo Assessment of Geno- and Cytotoxicity of Fluoridated Toothpastes and Mouthrinses on Buccal Epithelial Cells

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-31

Brief Summary

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Buccal cells represent the first barrier to the oral hygiene products' potential toxic effect. The usual concentration of fluoride in toothpastes is 1000/1100 parts per million (ppm F); toothpastes with higher (1500 ppm F) and lower than conventional fluoride levels (around 500 ppm F) are available in many countries. Toothpastes containing higher concentrations of fluoride confer greater protection against caries but at the same time the fluoride is able to induce harmful effects on oral mucosa cells.

The study would include around 40 participants, aged between 20 and 65, divided in two groups. Each group will use fluoride free toothpaste for 28 days, than afterwards group B will get toothpastes (each for 28 days) with no fluoride, 1045 ppm F and 1450 ppm F used together with mouthrinse containing 450 ppm F, while the group A will have everything the same except the mouthrinse that will contain no fluoride - a placebo mouthrinse.

Every 28 days buccal cells samples would be collected from each participant and a Buccal micronucleus cytome assay would be performed according to Nature protocols: Thomas et all.

The aim of this study would be to assess the possible cumulative effect of together use of fluoridated toothpastes and mouthrinses, since population worldwide uses them together without any exact studies about toxicity.

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Detailed Description

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Conditions

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DNA Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo mouthrinse

Group that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse without flouride for 28 days; toothpaste with 1050 ppm F and mouthrinse without flouride for 28 days; toothpaste with 1450 ppm F and mouthrinse without flouride for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo mouthrinse

Intervention Type OTHER

Mouthrinses without flouride

Fluoride in mouthrinses

Group that uses just toothpaste without fluoride for 28 days; toothpaste without flouride and mouthrinse with 450 ppm F for 28 days; toothpaste with 1050 ppm F and mouthrinse with 450 ppm F for 28 days; toothpaste with 1450 ppm F and mouthrinse with 450 ppm F for 28 days.

Group Type EXPERIMENTAL

Flouride in mouthrinses

Intervention Type OTHER

Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.

Interventions

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Flouride in mouthrinses

Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.

Intervention Type OTHER

Placebo mouthrinse

Mouthrinses without flouride

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subjects
* a sufficient level of education to understand the procedures
* patients not younger than 18 and not older than 65 years
* non-smokers
* patients without exposure to any x-ray examination in last 6 months