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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801576
• Other study ID #: EPuizina
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2022
• Source: University of Split, School of Medicine
• Contact: Ema Puizina Mladinic, M.D.
• Phone: 00385955749644
• Email: e.puizina[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2023
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• DNA Damage

Intervention

Other:
• Flouride in mouthrinses
Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.
• Placebo mouthrinse
Mouthrinses without flouride

Locations

Country	Name	City	State
Croatia	University of Split School of medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (5)

Ribeiro DA, Cardoso CM, Yujra VQ, DE Barros Viana M, Aguiar O Jr, Pisani LP, Oshima CTF. Fluoride Induces Apoptosis in Mammalian Cells: In Vitro and In Vivo Studies. Anticancer Res. 2017 Sep;37(9):4767-4777. Review. — View Citation

Tadin A, Gavic L, Govic T, Galic N, Zorica Vladislavic N, Zeljezic D. In vivo evaluation of fluoride and sodium lauryl sulphate in toothpaste on buccal epithelial cells toxicity. Acta Odontol Scand. 2019 Jul;77(5):386-393. doi: 10.1080/00016357.2019.1577988. Epub 2019 Feb 20. Erratum in: Acta Odontol Scand. 2019 Aug;77(6):483. — View Citation

Tadin A, Gavic L, Zeravica A, Ugrin K, Galic N, Zeljezic D. Assessment of cytotoxic and genotoxic effects of conventional and whitening kinds of toothpaste on oral mucosa cells. Acta Odontol Scand. 2018 Jan;76(1):64-70. doi: 10.1080/00016357.2017.1384567. — View Citation

Tadin A, Marovic D, Galic N, Kovacic I, Zeljezic D. Composite-induced toxicity in human gingival and pulp fibroblast cells. Acta Odontol Scand. 2014 May;72(4):304-11. doi: 10.3109/00016357.2013.824607. Epub 2013 Aug 22. — View Citation

Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-related cytotoxic and genotoxic events in buccal cells assessed by buccal cytome micronucleus assay.	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)