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Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine

Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03760367
Enrollment
24
Registered
2018-11-30
Start date
2018-11-13
Completion date
2018-11-23
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Whitening

Keywords

blue covarine, numeric analogue scale, spectrophotometry, tooth bleaching

Brief summary

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.

Detailed description

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.

Interventions

OTHERBlue covarine toothpaste

2 min toothbrushing with 1 g of Pepsodent White Now Gold

2 min toothbrushing with 1 g of Colgate Advanced Whitening

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants are randomly assigned to one of the two arms and perform the treatment without knowing whether they use the blue covarine toothpaste or the control toothpaste. Treatment outcomes are assessed by a) a blinded operator and b) the blinded participants in a different room. Allocation of treatment groups will be revealed to the principal investigator after all data have been collected.

Intervention model description

Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
3D VITA SYSTEM 3D-MASTER tooth color changeTooth color is measured twice, right before (baseline) and immediately after toothbrushing.Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Change of participant satisfaction with the tooth colorParticipant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.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).

Secondary

MeasureTime frameDescription
Change of blue-yellow color component of the tooth (b* in the CIELAB color space)The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.The change of the blue-yellow color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Change of the green-red color component of the tooth (a* in the CIELAB color space)The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.The change of the green-red color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Change of the tooth lightness value (L* in the CIELAB color space)The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.The change of lightness of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
Participant evaluation of tooth color changeThe color change of the upper front teeth is assessed once: immediately after toothbrushing.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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026