Tooth WhiteningNCT03760367
Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine
A study testing Blue covarine toothpaste in people with Tooth Whitening, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Whitening
- What is being tested?
- Blue covarine toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Nov 2018to 23 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Dentistry and Oral Health
Aarhus, 8000
About this study
Official title: Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Tooth Whitening
- Being tested
- Blue covarine toothpaste, Control toothpaste
- Keywords
- blue covarine, numeric analogue scale, spectrophotometry, tooth bleaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue covarine toothpasteOther
Also called Pepsodent White Now Gold
2 min toothbrushing with 1 g of Pepsodent White Now Gold
Control toothpasteOther
Also called Colgate Advanced Whitening
2 min toothbrushing with 1 g of Colgate Advanced Whitening
| Study group | Role | What they receive |
|---|---|---|
| Blue Covarine Toothpaste | Experimental | 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. Receives: Other: Blue covarine toothpaste |
| Control Toothpaste | Active comparator | 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. Receives: Other: Control toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.
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).
Measured: Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.
Secondary outcomes (4)
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.
Measured: The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.
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.
Measured: The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.
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.
Measured: The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.
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).
Measured: The color change of the upper front teeth is assessed once: immediately after toothbrushing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start13 Nov 2018
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WhiteningStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Schlafer, Dr., Principal investigator, Aarhus University, Department of Dentistry and Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760367
- Sponsor's protocol ID
- IOOS_TA_01_2018
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03760367
- Acronym / sponsor ID
- IOOS_TA_01_2018
- Conditions
- Tooth Whitening
- Keywords
- blue covarine, numeric analogue scale, spectrophotometry, tooth bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.
| Arm | Type | Receives |
|---|---|---|
| Blue Covarine Toothpaste | Experimental | Other: Blue covarine toothpasteAfter 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 | Active comparator | Other: Control toothpasteAfter 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue covarine toothpasteAlso: Pepsodent White Now Gold2 min toothbrushing with 1 g of Pepsodent White Now Gold | Other | Blue Covarine Toothpaste |
| Control toothpasteAlso: Colgate Advanced Whitening2 min toothbrushing with 1 g of Colgate Advanced Whitening | Other | Control Toothpaste |
Primary outcome
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.
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).
4 secondary outcomes
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.
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.
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.
Participant evaluation of tooth color change
Time frame: The color change of the upper front teeth is assessed once: immediately after toothbrushing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Schlafer, Dr. principal investigator
Aarhus University, Department of Dentistry and Oral Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue covarine toothpaste in people with Tooth Whitening, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D VITA SYSTEM 3D-MASTER tooth color change (time frame: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.