Teeth Whitening Clinical Trial
Official title:
Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06035588 -
Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days
|
N/A |