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

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ClinicalTrials.gov Identifier: NCT03760367
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Tooth Whitening Other: Blue covarine toothpaste Other: Control toothpaste Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.
Masking: Triple (Participant, 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.
Primary Purpose: Treatment
Official Title: Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Blue covarine toothpaste
2 min toothbrushing with 1 g of Pepsodent White Now Gold
Other Name: Pepsodent White Now Gold

Active Comparator: 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.
Other: Control toothpaste
2 min toothbrushing with 1 g of Colgate Advanced Whitening
Other Name: Colgate Advanced Whitening




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change of blue-yellow color component of the tooth (a* 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 (b* 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760367


Contacts
Contact: Sebastian Schlafer, Dr. +45-87167451 sebastians@dent.au.dk

Locations
Denmark
Aarhus University, Department of Dentistry and Oral Health Recruiting
Aarhus, Denmark, 8000
Contact: Sebastian Schlafer, Dr.    +45-87167451    sebastians@dent.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Sebastian Schlafer, Dr. Aarhus University, Department of Dentistry and Oral Health

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03760367     History of Changes
Other Study ID Numbers: IOOS_TA_01_2018
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
blue covarine
numeric analogue scale
spectrophotometry
tooth bleaching

Additional relevant MeSH terms:
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents