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

NCT03760367 | Completed DMC

• 1 other identifier: IOOS_TA_01_2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Whitening

Keywords

blue covarine; numeric analogue scale; spectrophotometry; tooth bleaching

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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 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 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 tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.

• Participant evaluation of tooth color change

  The color change of the upper front teeth is assessed once: immediately after toothbrushing.

Study Arms (2)

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.

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.

Other: Control toothpaste

Interventions

Blue covarine toothpaste OTHER

2 min toothbrushing with 1 g of Pepsodent White Now Gold

Also known as: Pepsodent White Now Gold

Blue Covarine Toothpaste

Control toothpaste OTHER

2 min toothbrushing with 1 g of Colgate Advanced Whitening

Also known as: Colgate Advanced Whitening

Control Toothpaste

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University, Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

Location

Study Officials

• Sebastian Schlafer, Dr.

  Aarhus University, Department of Dentistry and Oral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 30, 2018
• Study Start: November 13, 2018
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: November 19, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)