Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine
Condition: Tooth Whitening
Study type: Interventional

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.
    

Intervention name(s): Blue covarine toothpaste; Control toothpaste
Intervention type(s): Other; Other
Intervention description(s): 2 min toothbrushing with 1 g of Pepsodent White Now Gold; 2 min toothbrushing with 1 g of Colgate Advanced Whitening
Other intervention name(s): Pepsodent White Now Gold; Colgate Advanced Whitening
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)
Primary purpose: Treatment
Keywords: blue covarine; numeric analogue scale; spectrophotometry; tooth bleaching