Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-03 @ 3:22 AM
Study NCT ID:
NCT03760367
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2018-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: