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
Verified date | November 2018 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 23, 2018 |
Est. primary completion date | November 23, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Dental caries in the upper front teeth - Intrinsic stain of the upper front teeth, including tetracyclin stains, fluorosis, and staining due to pulpitis or pulp necrosis - Dental restorations in the upper front teeth, including fillings, veneers, crowns, and root canal fillings - Dental anomalies of the upper front teeth, including molar incisor hypomineralisation, amelogenesis imperfecta, and dentinogenesis imperfecta |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University, Department of Dentistry and Oral Health | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Tooth color is measured twice, right before (baseline) and immediately after toothbrushing. | |
Primary | 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). | Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing. | |
Secondary | 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. | The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing. | |
Secondary | 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. | The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing. | |
Secondary | 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. | The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing. | |
Secondary | 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). | The color change of the upper front teeth is assessed once: immediately after toothbrushing. |
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