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

NCT04801576 | Unknown

• 1 other identifier: EPuizina
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

DNA Damage

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Placebo mouthrinse

PLACEBO COMPARATOR

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

Fluoride in mouthrinses

EXPERIMENTAL

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

Interventions

Flouride in mouthrinses OTHER

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

Fluoride in mouthrinses

Placebo mouthrinse OTHER

Mouthrinses without flouride

Placebo mouthrinse

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of medicine

Split, 21000, Croatia

RECRUITING

Related Publications (5)

• 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.

  PMID: 30784350 BACKGROUND

• 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. Epub 2017 Sep 29.

  PMID: 28959909 RESULT

• 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.

  PMID: 23964631 RESULT

• 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. doi: 10.21873/anticanres.11883.

  PMID: 28870895 RESULT

• 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.

  PMID: 19444240 RESULT

Central Study Contacts

Ema Puizina Mladinić, M.D.

CONTACT

00385955749644; e.puizina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2021
• Primary Completion: February 21, 2021
• Study Completion: July 31, 2023
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)