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

Not Applicable

Completed

• Conditions: Tooth Whitening
• Interventions: Other: Blue covarine toothpaste; Other: Control toothpaste

• Registration Number: NCT03760367
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-13
• Study First Submitted: 2018-11-19
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy volunteers

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue Covarine Toothpaste	Blue covarine toothpaste	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.
Control Toothpaste	Control 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.

Primary Outcome Measures

Name	Time	Method
Change of participant satisfaction with the tooth color	Participant 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).
3D VITA SYSTEM 3D-MASTER tooth color change	Tooth 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.

Secondary Outcome Measures

Name	Time	Method
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 change	The 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).

Trial Locations

Locations (1)

Aarhus University, Department of Dentistry and Oral Health; 🇩🇰 Aarhus, Denmark