Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells

Summary

Bleaching discolored vital teeth is one of the most popular aesthetic treatment in dentistry in the last decade. Teeth whitening can be performed by professionals/dentists in the dental office ("in-office") and by the patients themselves at home (over-the-counter). A generally available method for teeth whitening is to use toothpastes which contain whitening ingredients. This method presents commercial option to remove discolorations on the enamel surface of vital teeth. There are many commercially available dentifrices that contain whitening agents, such as abrasives, chemical or optical agents. It has been noticed that whitening agents added in toothpastes can provide whitening effect visible to human eye that can objectively be evaluated by using sprectrophotometers. The results of teeth whitening can also be obtained subjectively by observation and comparison to tooth shade guide. Also, these products must be used with caution as they may cause some negative effects, such as dentinal hypersensitivity, irritations, peeling/exfoliation, dry mouth, rougher teeth and cytotoxic and genotoxic effect on oral mucosa cells. Studies that have already been conducted with whitening agents are based on abrasives, peroxides, optical agents and activated charcoal.

The main objective in this study is to investigate the effectiveness of different brands of toothpastes with whitening effect and their performance (effect) on oral mucosa cells. As a measure of genotoxicity and cytotoxicity in cells, the number of micronuclei and other morphological changes of the nucleus are determined (micronucleus assay). Other specific objectives are to investigate the patient satisfaction with the characteristic of treatment such as final tooth color, color stability, length of treatment, comfort during treatment and overall participant satisfaction.

Conditions

• Teeth Whitening

Interventions

OTHER

Control group

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

OTHER

Whitening toothpaste 1

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

OTHER

Whitening toothpaste 2

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

OTHER

Whitening toothpaste 3

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

OTHER

Whitening toothpaste 4

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

OTHER

Whitening toothpaste 5

A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage. Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day. Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.

Sponsors & Collaborators

• University of Zagreb

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2020-07-31

Completion

2020-09-30

Countries

• Croatia

Study Locations