Teeth WhiteningNCT04460755
Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells
A study testing Whitening toothpaste 1, Whitening toothpaste 2 and Whitening toothpaste 3 in people with Teeth Whitening, run by University of Zagreb at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Whitening
- What is being tested?
- Whitening toothpaste 1, Whitening toothpaste 2 and Whitening toothpaste 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Sample description and study design for this research was performed at the School of the Medicine, University of Split, Croatia.
Respondents are the students and employees of the School of the Medicine University of Split, Croatia. They will be divided in groups where different types of whitening toothpaste will be used. One group will use control non-whitening toothpaste. All respondents will use the same toothbrush during the research. Before using whitening toothpastes, all participants will use the same non-whitening toothpaste for one month. All participants will sign informed consent for participation in the research. Their participation will be voluntary. Respondents will be able to refuse to participate in the research without any consequences.
This study is approved by Ethic Committee of the School of Dental Medicine, Zagreb, Croatia (09.2018.) and Ethic Committee of the School of the Medicine University of Split, Croatia (12.2017). The study is randomized, prospective clinical trial.
The participants will be randomly selected for the whitening toothpaste groups and for the control non-whitening group. A sample of cells from the buccal mucosa area will be taken from each patient prior using the toothpastes under test, 30 and 60 days after the beginning and 30 days after using the toothpastes under test. Color assessment will be performed four times using the Vita Easyshade digital spectrophotometer: T0- before treatment (initial); T1- 30 days after the beginning; T2- 60 days after the beginning and T3- 90 days after the beginning of the study (i.e. 30 days after completing the treatment). The color reading will be performed in the middle third of the labial surface of the tooth, in the same environment and with the same light conditions. The measurement will be performed on all vital six anterior maxillary teeth, free of caries and restorations. Participant's satisfaction with the treatment and the toothpaste used will be assessed using the prepared questionnaires.
Participants will use toothpastes under test for two months. Toothpaste will be applied twice a day, in the morning and in the evening, for three minutes for 1g (app. 2 cm). During the experiment, the examinees will not use any toothpaste other than the one under test. Participants will use no other agents for oral hygiene.
- Conditions
- Teeth Whitening
- Being tested
- Control group, Whitening toothpaste 1, Whitening toothpaste 2, Whitening toothpaste 3, Whitening toothpaste 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
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 1Other
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 2Other
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 3Other
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 4Other
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 5Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | A group of participants that will be using toothpaste without tooth whitening ingredients. Receives: Other: Control group |
| Whitening toothpaste 1 | Experimental | A group of participants that will be using urea peroxide whitening toothpastes. Receives: Other: Whitening toothpaste 1 |
| Whitening toothpaste 2 | Experimental | A group of participants that will be using hydrogen peroxide whitening toothpastes. Receives: Other: Whitening toothpaste 2 |
| Whitening toothpaste 3 | Experimental | A group of participants that will be using whitening toothpastes that contain abrasive ingredients. Receives: Other: Whitening toothpaste 3 |
| Whitening toothpaste 4 | Experimental | A group of participants that will be using whitening toothpastes that contain enzymes as whitening ingredients. Receives: Other: Whitening toothpaste 4 |
| Whitening toothpaste 5 | Experimental | A group of participants that will be using toothpastes that contain an activated charcoal. Receives: Other: Whitening toothpaste 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (2)
Assessment of participant's satisfaction with treatment and used toothpaste after 60 days of treatment
Assessment of participant's satisfaction with treatment and used toothpaste will be performed by prepared questionnaire for the study. Respondents will complete a questionnaire of eating and living habits, too
Measured: 60 days
Assessment of participant's satisfaction with treatment of used toothpaste 30 days after the treatment (90 days from the beginning of treatment)
Assessment of participant's satisfaction with treatment and used toothpaste will be performed by prepared questionnaire for the study.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jan 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Teeth WhiteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is randomized, prospective clinical trial.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Zorica Vladislavic, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460755
- Sponsor's protocol ID
- 05-PA-30-9/2018.
- Other IDs
- 2181-198-03-04-17-0063
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joiner A. Whitening toothpastes: a review of the literature. J Dent. 2010;38 Suppl 2:e17-24. doi: 10.1016/j.jdent.2010.05.017. Epub 2010 May 24.
PubMed 20562012Epple M, Meyer F, Enax J. A Critical Review of Modern Concepts for Teeth Whitening. Dent J (Basel). 2019 Aug 1;7(3):79. doi: 10.3390/dj7030079.
PubMed 31374877van Loveren C, Duckworth RM. Anti-calculus and whitening toothpastes. Monogr Oral Sci. 2013;23:61-74. doi: 10.1159/000350698. Epub 2013 Jun 28.
PubMed 23817060Lippert F. An introduction to toothpaste - its purpose, history and ingredients. Monogr Oral Sci. 2013;23:1-14. doi: 10.1159/000350456. Epub 2013 Jun 28.
PubMed 23817056Pickles MJ, Evans M, Philpotts CJ, Joiner A, Lynch RJ, Noel N, Laucello M. In vitro efficacy of a whitening toothpaste containing calcium carbonate and perlite. Int Dent J. 2005;55(3 Suppl 1):197-202. doi: 10.1111/j.1875-595x.2005.tb00060.x.
PubMed 16004254Collins LZ, Naeeni M, Schafer F, Brignoli C, Schiavi A, Roberts J, Colgan P. The effect of a calcium carbonate/perlite toothpaste on the removal of extrinsic tooth stain in two weeks. Int Dent J. 2005;55(3 Suppl 1):179-82. doi: 10.1111/j.1875-595x.2005.tb00056.x.
PubMed 16004250Kalliath C, Mukunda A, Pynadath M, Venugopal V, Prethweeraj J. Comparison between the effect of commercially available chemical teeth whitening paste and teeth whitening paste containing ingredients of herbal origin on human enamel. Ayu. 2018 Apr-Jun;39(2):113-117. doi: 10.4103/ayu.AYU_82_18.
PubMed 30783367Patil PA, Ankola AV, Hebbal MI, Patil AC. Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial. Int J Dent Hyg. 2015 Feb;13(1):25-9. doi: 10.1111/idh.12090. Epub 2014 Jul 21.
PubMed 25046241Kalyana P, Shashidhar A, Meghashyam B, Sreevidya KR, Sweta S. Stain removal efficacy of a novel dentifrice containing papain and Bromelain extracts--an in vitro study. Int J Dent Hyg. 2011 Aug;9(3):229-33. doi: 10.1111/j.1601-5037.2010.00473.x. Epub 2010 Jul 1.
PubMed 21356017Hara AT, Turssi CP. Baking soda as an abrasive in toothpastes: Mechanism of action and safety and effectiveness considerations. J Am Dent Assoc. 2017 Nov;148(11S):S27-S33. doi: 10.1016/j.adaj.2017.09.007.
PubMed 29056187Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S. Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth. J Clin Dent. 2012;23(3):86-91.
PubMed 23210419Vaz VTP, Jubilato DP, Oliveira MRM, Bortolatto JF, Floros MC, Dantas AAR, Oliveira Junior OB. Whitening toothpaste containing activated charcoal, blue covarine, hydrogen peroxide or microbeads: which one is the most effective? J Appl Oral Sci. 2019 Jan 14;27:e20180051. doi: 10.1590/1678-7757-2018-0051.
PubMed 30673027Franco MC, Uehara J, Meroni BM, Zuttion GS, Cenci MS. The Effect of a Charcoal-based Powder for Enamel Dental Bleaching. Oper Dent. 2020 Nov 1;45(6):618-623. doi: 10.2341/19-122-L.
PubMed 32243248Joiner A, Luo W. Tooth colour and whiteness: A review. J Dent. 2017 Dec;67S:S3-S10. doi: 10.1016/j.jdent.2017.09.006. Epub 2017 Sep 18.
PubMed 28928097Korifi R, Le Dreau Y, Antinelli JF, Valls R, Dupuy N. CIEL*a*b* color space predictive models for colorimetry devices--analysis of perfume quality. Talanta. 2013 Jan 30;104:58-66. doi: 10.1016/j.talanta.2012.11.026. Epub 2012 Nov 23.
PubMed 23597889
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells
- ClinicalTrials.gov ID
- NCT04460755
- Acronym / sponsor ID
- 05-PA-30-9/2018.
- Conditions
- Teeth Whitening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample description and study design for this research was performed at the School of the Medicine, University of Split, Croatia.
Respondents are the students and employees of the School of the Medicine University of Split, Croatia. They will be divided in groups where different types of whitening toothpaste will be used. One group will use control non-whitening toothpaste. All respondents will use the same toothbrush during the research. Before using whitening toothpastes, all participants will use the same non-whitening toothpaste for one month. All participants will sign informed consent for participation in the research. Their participation will be voluntary. Respondents will be able to refuse to participate in the research without any consequences.
This study is approved by Ethic Committee of the School of Dental Medicine, Zagreb, Croatia (09.2018.) and Ethic Committee of the School of the Medicine University of Split, Croatia (12.2017). The study is randomized, prospective clinical trial.
The participants will be randomly selected for the whitening toothpaste groups and for the control non-whitening group. A sample of cells from the buccal mucosa area will be taken from each patient prior using the toothpastes under test, 30 and 60 days after the beginning and 30 days after using the toothpastes under test. Color assessment will be performed four times using the Vita Easyshade digital spectrophotometer: T0- before treatment (initial); T1- 30 days after the beginning; T2- 60 days after the beginning and T3- 90 days after the beginning of the study (i.e. 30 days after completing the treatment). The color reading will be performed in the middle third of the labial surface of the tooth, in the same environment and with the same light conditions. The measurement will be performed on all vital six anterior maxillary teeth, free of caries and restorations. Participant's satisfaction with the treatment and the toothpaste used will be assessed using the prepared questionnaires.
Participants will use toothpastes under test for two months. Toothpaste will be applied twice a day, in the morning and in the evening, for three minutes for 1g (app. 2 cm). During the experiment, the examinees will not use any toothpaste other than the one under test. Participants will use no other agents for oral hygiene.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The study is randomized, prospective clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupA group of participants that will be using toothpaste without tooth whitening ingredients. |
| Whitening toothpaste 1 | Experimental | Other: Whitening toothpaste 1A group of participants that will be using urea peroxide whitening toothpastes. |
| Whitening toothpaste 2 | Experimental | Other: Whitening toothpaste 2A group of participants that will be using hydrogen peroxide whitening toothpastes. |
| Whitening toothpaste 3 | Experimental | Other: Whitening toothpaste 3A group of participants that will be using whitening toothpastes that contain abrasive ingredients. |
| Whitening toothpaste 4 | Experimental | Other: Whitening toothpaste 4A group of participants that will be using whitening toothpastes that contain enzymes as whitening ingredients. |
| Whitening toothpaste 5 | Experimental | Other: Whitening toothpaste 5A group of participants that will be using toothpastes that contain an activated charcoal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- pregnant women
- breastfeeding women
- individuals with discolored teeth (tetracycline stain, fluorosis)
- tooth sensitivity
- history of allergy to any dental hygiene product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupA 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 | Control group |
| Whitening toothpaste 1A 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 |
| Whitening toothpaste 2A 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 |
| Whitening toothpaste 3A 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 |
| Whitening toothpaste 4A 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 |
| Whitening toothpaste 5A 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 |
Primary outcome
Color assessment before the treatment (T0)
Time frame: 0 days
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.
Color change after 30 days of treatment (T1)
Time frame: 30 days
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.
Color change after 60 days of treatment (T2)
Time frame: 60 days
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.
Color change 30 days after the treatment (90 days from the beginning of treatment) (T3)
Time frame: 90 days
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.
Assessment of biocompatibility before the treatment (T0)
Time frame: 0 days
Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.
Assessment of biocompatibility after 30 days of treatment (T1)
Time frame: 30 days
Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.
Assessment of biocompatibility after 60 days of treatment (T2)
Time frame: 60 days
Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.
Assessment of biocompatibility 30 days after the treatment (90 days from the beginning of treatment) (T3)
Time frame: 90 days
Assessment of biocompatibility through cytotoxicity and genotoxicity parameters of commercially available toothpastes with whitening effect will be performed using micronucleus assay.
2 secondary outcomes
Assessment of participant's satisfaction with treatment and used toothpaste after 60 days of treatment
Time frame: 60 days
Assessment of participant's satisfaction with treatment of used toothpaste 30 days after the treatment (90 days from the beginning of treatment)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 20562012Joiner A. Whitening toothpastes: a review of the literature. J Dent. 2010;38 Suppl 2:e17-24. doi: 10.1016/j.jdent.2010.05.017. Epub 2010 May 24.
- Background: PubMed 31374877Epple M, Meyer F, Enax J. A Critical Review of Modern Concepts for Teeth Whitening. Dent J (Basel). 2019 Aug 1;7(3):79. doi: 10.3390/dj7030079.
- Background: PubMed 23817060van Loveren C, Duckworth RM. Anti-calculus and whitening toothpastes. Monogr Oral Sci. 2013;23:61-74. doi: 10.1159/000350698. Epub 2013 Jun 28.
- Background: PubMed 23817056Lippert F. An introduction to toothpaste - its purpose, history and ingredients. Monogr Oral Sci. 2013;23:1-14. doi: 10.1159/000350456. Epub 2013 Jun 28.
- Background: PubMed 16004254Pickles MJ, Evans M, Philpotts CJ, Joiner A, Lynch RJ, Noel N, Laucello M. In vitro efficacy of a whitening toothpaste containing calcium carbonate and perlite. Int Dent J. 2005;55(3 Suppl 1):197-202. doi: 10.1111/j.1875-595x.2005.tb00060.x.
- Background: PubMed 16004250Collins LZ, Naeeni M, Schafer F, Brignoli C, Schiavi A, Roberts J, Colgan P. The effect of a calcium carbonate/perlite toothpaste on the removal of extrinsic tooth stain in two weeks. Int Dent J. 2005;55(3 Suppl 1):179-82. doi: 10.1111/j.1875-595x.2005.tb00056.x.
- Background: PubMed 30783367Kalliath C, Mukunda A, Pynadath M, Venugopal V, Prethweeraj J. Comparison between the effect of commercially available chemical teeth whitening paste and teeth whitening paste containing ingredients of herbal origin on human enamel. Ayu. 2018 Apr-Jun;39(2):113-117. doi: 10.4103/ayu.AYU_82_18.
- Background: PubMed 25046241Patil PA, Ankola AV, Hebbal MI, Patil AC. Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial. Int J Dent Hyg. 2015 Feb;13(1):25-9. doi: 10.1111/idh.12090. Epub 2014 Jul 21.
- Background: PubMed 21356017Kalyana P, Shashidhar A, Meghashyam B, Sreevidya KR, Sweta S. Stain removal efficacy of a novel dentifrice containing papain and Bromelain extracts--an in vitro study. Int J Dent Hyg. 2011 Aug;9(3):229-33. doi: 10.1111/j.1601-5037.2010.00473.x. Epub 2010 Jul 1.
- Background: PubMed 29056187Hara AT, Turssi CP. Baking soda as an abrasive in toothpastes: Mechanism of action and safety and effectiveness considerations. J Am Dent Assoc. 2017 Nov;148(11S):S27-S33. doi: 10.1016/j.adaj.2017.09.007.
- Background: PubMed 23210419Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S. Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth. J Clin Dent. 2012;23(3):86-91.
- Background: PubMed 30673027Vaz VTP, Jubilato DP, Oliveira MRM, Bortolatto JF, Floros MC, Dantas AAR, Oliveira Junior OB. Whitening toothpaste containing activated charcoal, blue covarine, hydrogen peroxide or microbeads: which one is the most effective? J Appl Oral Sci. 2019 Jan 14;27:e20180051. doi: 10.1590/1678-7757-2018-0051.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whitening toothpaste 1, Whitening toothpaste 2 and Whitening toothpaste 3 in people with Teeth Whitening, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color assessment before the treatment (T0) (time frame: 0 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460755, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.