An interventional study of Blue covarine toothpaste and Control toothpaste in Tooth Whitening, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste containing blue covarine (Pepsodent White Now Gold, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.
Other: Blue covarine toothpaste
After a short video introduction to the bass technique, participants brush their teeth once with a silica toothpaste (Colgate Advanced Whitening, 1 g) for 2 min, starting with the upper front teeth. Thereafter, participants rinse their mouth with of tap water.
Other: Control toothpaste
2 min toothbrushing with 1 g of Pepsodent White Now Gold
Also known as: Pepsodent White Now Gold
2 min toothbrushing with 1 g of Colgate Advanced Whitening
Also known as: Colgate Advanced Whitening
3D VITA SYSTEM 3D-MASTER tooth color change
Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Time frame: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.
Change of participant satisfaction with the tooth color
Change of participant satisfaction with the color of their upper front teeth is assessed after toothbrushing compared to baseline using an 11 step aesthetic numeric analogue scale (ANA scale, Funk et al., 2011; DOI: https://doi.org/10.1016/j.jcms.2011.07.018).
Time frame: Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.
Change of blue-yellow color component of the tooth (b* in the CIELAB color space)
The change of the blue-yellow color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Time frame: The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.
Change of the green-red color component of the tooth (a* in the CIELAB color space)
The change of the green-red color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Time frame: The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.
Change of the tooth lightness value (L* in the CIELAB color space)
The change of lightness of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Time frame: The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.
Participant evaluation of tooth color change
The color change of their upper front teeth is assessed visually by the participants using an 11 step aesthetic numeric analogue scale (ANA scale, Funk et al., 2011; DOI: https://doi.org/10.1016/j.jcms.2011.07.018).
Time frame: The color change of the upper front teeth is assessed once: immediately after toothbrushing.
Plan to share: No — Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.
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University of Aarhus