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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760367
Other study ID # IOOS_TA_01_2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 13, 2018
Est. completion date November 23, 2018

Study information

Verified date November 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blue covarine toothpaste
2 min toothbrushing with 1 g of Pepsodent White Now Gold
Control toothpaste
2 min toothbrushing with 1 g of Colgate Advanced Whitening

Locations

Country Name City State
Denmark Aarhus University, Department of Dentistry and Oral Health Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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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