Clinical trial NCT03760367: Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine
Official title: Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Whitening
Keywords: blue covarine
numeric analogue scale
spectrophotometry
tooth bleaching
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 3D VITA SYSTEM 3D-MASTER tooth color change
timeFrame: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.
measure: Change of participant satisfaction with the tooth color
timeFrame: Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.
Secondary outcomes:
measure: Change of blue-yellow color component of the tooth (b* in the CIELAB color space)
timeFrame: The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.
measure: Change of the green-red color component of the tooth (a* in the CIELAB color space)
timeFrame: The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.
measure: Change of the tooth lightness value (L* in the CIELAB color space)
timeFrame: The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.
measure: Participant evaluation of tooth color change
timeFrame: The color change of the upper front teeth is assessed once: immediately after toothbrushing.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Dentistry and Oral Health
Study officials:
affiliation: Aarhus University, Department of Dentistry and Oral Health
name: Sebastian Schlafer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: