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Completed

NCT Number: NCT03760367

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue covarine toothpaste

Other

2 min toothbrushing with 1 g of Pepsodent White Now Gold

Other names: Pepsodent White Now Gold

Control toothpaste

Other

2 min toothbrushing with 1 g of Colgate Advanced Whitening

Other names: Colgate Advanced Whitening

Primary outcomes

  1. 3D VITA SYSTEM 3D-MASTER tooth color change

    Time frame: 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.

  2. Change of participant satisfaction with the tooth color

    Time frame: 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).

Secondary outcomes

  1. Change of blue-yellow color component of the tooth (b* in the CIELAB color space)

    Time frame: 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.

  2. Change of the green-red color component of the tooth (a* in the CIELAB color space)

    Time frame: 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.

  3. Change of the tooth lightness value (L* in the CIELAB color space)

    Time frame: 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.

  4. Participant evaluation of tooth color change

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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