Cytogenetic Damage in Buccal Cells Caused by Toothpaste

NCT03325400 | Completed

• 1 other identifier: USplitSM
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives. Toothpaste contains many potentially harmful ingredients, including some that can lead to serious long-term health problems. Everyday use of oral health care products has increased, highlighting the need for healthcare clinicians and consumers to be informed of the potential benefits and risks associated with these products. The aim of this study is to evaluate possible DNA damages to oral epithelial cells in participants exposed to toothpaste containing fluoride as opposed to the effects of non-fluoride toothpaste. Materials and Methods. Forty volunteers were selected among students of dental medicine and assigned into two experimental groups. Each group used regular non-fluoride toothpaste for initial two months, followed by the use of fluoride toothpaste of the same brand for the next two months. The buccal epithelial cells were sampled at baseline and 30, 60, 90 and 120 days after the beginning of the research. Chromosomal damages were analyzed by micronucleus assay.

Conditions

Toxicity

Keywords

Fluoride toothpaste; Cytogenetic damage; Exfoliated buccal cells; Micronucleus assay

Outcome Measures

Primary Outcomes (1)

• Cytogenetic damage

  The aim of this study was to assess the number of buccal epithelial cells with cytogenetic defects in participants using commercial toothpaste with and without fluoride of the same manufactures and similar composition. Using the micronucleus assay, the effect of toothpaste on the buccal cells was monitored, depending on the time of the exposure.

  four months

Study Arms (2)

Non-fluoride toothpaste

OTHER

Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Contemporary, participants did not use other agents for oral hygiene such as mouthwash or topical fluoridation.

Other: Toothpaste non-fluoride and fluoride

Fluoride toothpaste

ACTIVE COMPARATOR

Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Contemporary, participants did not use other agents for oral hygiene such as mouthwash or topical fluoridation.

Other: Toothpaste non-fluoride and fluoride

Interventions

Toothpaste non-fluoride and fluoride OTHER

Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Contemporary, participants did not use other agents for oral hygiene such as mouthwash or topical fluoridation.

Also known as: Sensodyne Classic (GlaxoSmithKline, UK), Sensodyne Fluor (GlaxoSmithKline, UK), Plidenta 15 Seconds (Neva Ltd., Croatia), Plidenta Sensitive (Neva Ltd., Croatia)

Fluoride toothpaste; Non-fluoride toothpaste

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• completely healthy (no systemic disorders and diseases)

You may not qualify if:

• consuming two or more alcohol units for three or more times a week
• patients with oral lesions
• history of malignancy
• patients with removable and fixed prosthodontics, orthodontic appliances.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Interventions

Fluorides; halofantrine

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: January 1, 2016
• Primary Completion: June 15, 2016
• Study Completion: July 20, 2016
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share