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

January 27, 2022 updated by: Ema Puizina Mladinić, MD, University of Split, School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • 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 Contact

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Recruiting
        • University of Split School of Medicine
        • 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

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • subjects with use of any medications
  • subjects that use alcohol
  • subjects with oral lesions
  • subjects with history of chronic health conditions

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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.
Other: Placebo mouthrinse
Mouthrinses without flouride
EXPERIMENTAL: 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.
Other: Flouride in mouthrinses
Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay.
Time Frame: 112 days (4 periods of 28 days)
Method used is Buccal Micronucleus Cytome (BMCyt) assay as minimally invasive method for studying DNA damage, chromosomal instability, cell death and the regenerative potential of human buccal mucosal tissue. This is one of the current established methods for buccal cell collection using a small-headed toothbrush, the generation of a single-cell suspension, slide preparation using cytocentrifugation, fixation and staining using Feulgen and Light Green for both bright field and fluorescence microscopic analysis.
112 days (4 periods of 28 days)

Collaborators and Investigators

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

Sponsor

University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

February 21, 2021

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (ACTUAL)

March 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • EPuizina

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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