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

NCT04460755 | Unknown

• 2 other identifiers: 05-PA-30-9/2018.2181-198-03-04-17-0063
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Color assessment before the treatment (T0)

  The following measurements were will be recorded: L\*,a\*, b\* values for all teeth as well as the tooth shade. The color was will be established by CIELAB color space. ΔE is will be calculated using the following formula: ΔE=√(〖(ΔL\*)〗\^2+〖(Δa\*)〗\^2+〖(Δb\*)〗\^2 ). The color changes between the evaluation times in each tested group and between groups were will be analysed using the ΔE, ΔL\*, Δa\* and Δb\*values. To calculate the difference in tooth shade according to the Vita Classical scale, the recorded values were will be ordered in scores from 1 to 16 in a luminosity sequence.

  0 days

• Color change after 30 days of treatment (T1)

  The following measurements were will be recorded: L\*,a\*, b\* values for all teeth as well as the tooth shade. The color was will be established by CIELAB color space. ΔE is will be calculated using the following formula: ΔE=√(〖(ΔL\*)〗\^2+〖(Δa\*)〗\^2+〖(Δb\*)〗\^2 ). The color changes between the evaluation times in each tested group and between groups were will be analysed using the ΔE, ΔL\*, Δa\* and Δb\*values. To calculate the difference in tooth shade according to the Vita Classical scale, the recorded values were will be ordered in scores from 1 to 16 in a luminosity sequence.

  30 days

• Color change after 60 days of treatment (T2)

  The following measurements were will be recorded: L\*,a\*, b\* values for all teeth as well as the tooth shade. The color was will be established by CIELAB color space. ΔE is will be calculated using the following formula: ΔE=√(〖(ΔL\*)〗\^2+〖(Δa\*)〗\^2+〖(Δb\*)〗\^2 ). The color changes between the evaluation times in each tested group and between groups were will be analysed using the ΔE, ΔL\*, Δa\* and Δb\*values. To calculate the difference in tooth shade according to the Vita Classical scale, the recorded values were will be ordered in scores from 1 to 16 in a luminosity sequence.

  60 days

• Color change 30 days after the treatment (90 days from the beginning of treatment) (T3)

  The following measurements were will be recorded: L\*,a\*, b\* values for all teeth as well as the tooth shade. The color was will be established by CIELAB color space. ΔE is will be calculated using the following formula: ΔE=√(〖(ΔL\*)〗\^2+〖(Δa\*)〗\^2+〖(Δb\*)〗\^2 ). The color changes between the evaluation times in each tested group and between groups were will be analysed using the ΔE, ΔL\*, Δa\* and Δb\*values. To calculate the difference in tooth shade according to the Vita Classical scale, the recorded values were will be ordered in scores from 1 to 16 in a luminosity sequence.

  90 days

• Assessment of biocompatibility before the treatment (T0)

  Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.

  0 days

• Assessment of biocompatibility after 30 days of treatment (T1)

  Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.

  30 days

• Assessment of biocompatibility after 60 days of treatment (T2)

  Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.

  60 days

• Assessment of biocompatibility 30 days after the treatment (90 days from the beginning of treatment) (T3)

  Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.

  90 days

Secondary Outcomes (2)

• Assessment of participant's satisfaction with treatment and used toothpaste after 60 days of treatment

  60 days

• Assessment of participant's satisfaction with treatment of used toothpaste 30 days after the treatment (90 days from the beginning of treatment)

  90 days

Study Arms (6)

Control group

ACTIVE COMPARATOR

A group of participants that will be using toothpaste without tooth whitening ingredients.

Other: Control group

Whitening toothpaste 1

EXPERIMENTAL

A group of participants that will be using urea peroxide whitening toothpastes.

Other: Whitening toothpaste 1

Whitening toothpaste 2

EXPERIMENTAL

A group of participants that will be using hydrogen peroxide whitening toothpastes.

Other: Whitening toothpaste 2

Whitening toothpaste 3

EXPERIMENTAL

A group of participants that will be using whitening toothpastes that contain abrasive ingredients.

Other: Whitening toothpaste 3

Whitening toothpaste 4

EXPERIMENTAL

A group of participants that will be using whitening toothpastes that contain enzymes as whitening ingredients.

Other: Whitening toothpaste 4

Whitening toothpaste 5

EXPERIMENTAL

A group of participants that will be using toothpastes that contain an activated charcoal.

Other: Whitening toothpaste 5

Interventions

Control group OTHER

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.

Control group

Whitening toothpaste 1 OTHER

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.

Whitening toothpaste 1

Whitening toothpaste 2 OTHER

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.

Whitening toothpaste 2

Whitening toothpaste 3 OTHER

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.

Whitening toothpaste 3

Whitening toothpaste 4 OTHER

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.

Whitening toothpaste 4

Whitening toothpaste 5 OTHER

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.

Whitening toothpaste 5

Eligibility Criteria

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

You may qualify if:

• age of 18 and older
• non smokers
• good oral and general health
• excellent oral hygiene
• vital six anterior maxillary teeth free of caries or restorations
• tooth shade A2 or darker
• no cervical lesions or prosthodontic treatments
• no periodontal disease

You may not qualify if:

• pregnant women
• breastfeeding women
• individuals with discolored teeth (tetracycline stain, fluorosis)
• tooth sensitivity
• history of allergy to any dental hygiene product
• individuals who had previously undergone any tooth whitening treatment

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of the Medicine, University of Split

Split, 21000, Croatia

Location

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MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells

Model Details: The study is randomized, prospective clinical trial.

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 8, 2020
• Study Start: January 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CR (1)