Tooth Whitening Clinical Trial
Official title:
Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
The study investigates the effect of toothbrushing with a toothpaste containing blue covarine
compared to a control toothpaste without blue covarine on tooth color. Participants brush
their teeth once with either the blue covarine containing toothpaste or a control toothpaste
for two minutes. Before and after brushing, tooth color is assessed with a spectrophotometer.
Moreover, satisfaction of the participants with their tooth color is assessed using a numeric
analogue scale before and after treatment.
The null hypotheses are that neither brushing with the toothpaste containing blue covarine
nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of
the participants with their tooth color.
Participants are recruited by advertizing in several public areas in Aarhus, Denmark.
Written and oral information on the study is provided, eligibility criteria are checked, and
informed consent is given by the participants.
The upper front teeth of the participants are cleaned with pumice and a rubber cup by
operator A.
Participants look at the color of their upper front teeth with a mirror, in a room with
controlled lighting conditions.
Thereafter, participants rate their satisfaction with the color of their teeth using an
11-point aesthetic numeric analogue scale.
Tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and
a positioning device to standardize measurements. Measurements are performed in a room with
controlled lighting conditions. VITA SYSTEM 3D-MASTER color, L*, a* and b* are recorded.
Participants are then randomly assigned to either the blue covarine toothpaste group or the
control toothpaste group.
They are given a short video introduction to the Bass toothbrushing technique by operator C
(caregiver).
Operator C provides a toothbrush and 1 g of either blue covarine toothpaste or control
toothpaste, according to the randomization scheme.
Participants brush their teeth for two min, starting with the upper front teeth, and then
rinse their mouth with tap water.
Thereafter, participants look again at the color of their upper front teeth with a mirror, in
the same room as before treatment.
They rate their satisfaction with the color of their teeth using the 11-point aesthetic
numeric analogue scale.
Moreover, they rate the color difference before and after treatment on an 11-point aesthetic
numeric analogue scale.
Again, tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade
Advance) and a positioning device to standardize measurements. Measurements are performed in
the room with controlled lighting conditions. Again VITA SYSTEM 3D-MASTER color, L*, a* and
b* are recorded.
The null hypotheses of the study are that neither brushing with the toothpaste containing
blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the
satisfaction of the participants with their tooth color.
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