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

Not Applicable

• Conditions: DNA Damage
• Interventions: Other: Placebo mouthrinse; Other: Flouride in mouthrinses

• Registration Number: NCT04801576
• Lead Sponsor: University of Split, School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-02-21
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-17
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo mouthrinse	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.
Fluoride in mouthrinses	Flouride 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.

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay.	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.

Trial Locations

Locations (1)

University of Split School of medicine; 🇭🇷 Split, Croatia