<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760367</url>
  </required_header>
  <id_info>
    <org_study_id>IOOS_TA_01_2018</org_study_id>
    <nct_id>NCT03760367</nct_id>
  </id_info>
  <brief_title>Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine</brief_title>
  <official_title>Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates the effect of toothbrushing with a toothpaste containing blue covarine&#xD;
      compared to a control toothpaste without blue covarine on tooth color. Participants brush&#xD;
      their teeth once with either the blue covarine containing toothpaste or a control toothpaste&#xD;
      for two minutes. Before and after brushing, tooth color is assessed with a spectrophotometer.&#xD;
      Moreover, satisfaction of the participants with their tooth color is assessed using a numeric&#xD;
      analogue scale before and after treatment.&#xD;
&#xD;
      The null hypotheses are that neither brushing with the toothpaste containing blue covarine&#xD;
      nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of&#xD;
      the participants with their tooth color.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are recruited by advertizing in several public areas in Aarhus, Denmark.&#xD;
&#xD;
      Written and oral information on the study is provided, eligibility criteria are checked, and&#xD;
      informed consent is given by the participants.&#xD;
&#xD;
      The upper front teeth of the participants are cleaned with pumice and a rubber cup by&#xD;
      operator A.&#xD;
&#xD;
      Participants look at the color of their upper front teeth with a mirror, in a room with&#xD;
      controlled lighting conditions.&#xD;
&#xD;
      Thereafter, participants rate their satisfaction with the color of their teeth using an&#xD;
      11-point aesthetic numeric analogue scale.&#xD;
&#xD;
      Tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade Advance) and&#xD;
      a positioning device to standardize measurements. Measurements are performed in a room with&#xD;
      controlled lighting conditions. VITA SYSTEM 3D-MASTER color, L*, a* and b* are recorded.&#xD;
&#xD;
      Participants are then randomly assigned to either the blue covarine toothpaste group or the&#xD;
      control toothpaste group.&#xD;
&#xD;
      They are given a short video introduction to the Bass toothbrushing technique by operator C&#xD;
      (caregiver).&#xD;
&#xD;
      Operator C provides a toothbrush and 1 g of either blue covarine toothpaste or control&#xD;
      toothpaste, according to the randomization scheme.&#xD;
&#xD;
      Participants brush their teeth for two min, starting with the upper front teeth, and then&#xD;
      rinse their mouth with tap water.&#xD;
&#xD;
      Thereafter, participants look again at the color of their upper front teeth with a mirror, in&#xD;
      the same room as before treatment.&#xD;
&#xD;
      They rate their satisfaction with the color of their teeth using the 11-point aesthetic&#xD;
      numeric analogue scale.&#xD;
&#xD;
      Moreover, they rate the color difference before and after treatment on an 11-point aesthetic&#xD;
      numeric analogue scale.&#xD;
&#xD;
      Again, tooth color is assessed by operator B using a spectrophotometer (VITA Easyshade&#xD;
      Advance) and a positioning device to standardize measurements. Measurements are performed in&#xD;
      the room with controlled lighting conditions. Again VITA SYSTEM 3D-MASTER color, L*, a* and&#xD;
      b* are recorded.&#xD;
&#xD;
      The null hypotheses of the study are that neither brushing with the toothpaste containing&#xD;
      blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the&#xD;
      satisfaction of the participants with their tooth color.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">November 23, 2018</completion_date>
  <primary_completion_date type="Actual">November 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>3D VITA SYSTEM 3D-MASTER tooth color change</measure>
    <time_frame>Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.</time_frame>
    <description>Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of participant satisfaction with the tooth color</measure>
    <time_frame>Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of blue-yellow color component of the tooth (b* in the CIELAB color space)</measure>
    <time_frame>The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.</time_frame>
    <description>The change of the blue-yellow color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the green-red color component of the tooth (a* in the CIELAB color space)</measure>
    <time_frame>The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.</time_frame>
    <description>The change of the green-red color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the tooth lightness value (L* in the CIELAB color space)</measure>
    <time_frame>The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.</time_frame>
    <description>The change of lightness of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant evaluation of tooth color change</measure>
    <time_frame>The color change of the upper front teeth is assessed once: immediately after toothbrushing.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Tooth Whitening</condition>
  <arm_group>
    <arm_group_label>Blue Covarine Toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Toothpaste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blue covarine toothpaste</intervention_name>
    <description>2 min toothbrushing with 1 g of Pepsodent White Now Gold</description>
    <arm_group_label>Blue Covarine Toothpaste</arm_group_label>
    <other_name>Pepsodent White Now Gold</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control toothpaste</intervention_name>
    <description>2 min toothbrushing with 1 g of Colgate Advanced Whitening</description>
    <arm_group_label>Control Toothpaste</arm_group_label>
    <other_name>Colgate Advanced Whitening</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dental caries in the upper front teeth&#xD;
&#xD;
          -  Intrinsic stain of the upper front teeth, including tetracyclin stains, fluorosis, and&#xD;
             staining due to pulpitis or pulp necrosis&#xD;
&#xD;
          -  Dental restorations in the upper front teeth, including fillings, veneers, crowns, and&#xD;
             root canal fillings&#xD;
&#xD;
          -  Dental anomalies of the upper front teeth, including molar incisor hypomineralisation,&#xD;
             amelogenesis imperfecta, and dentinogenesis imperfecta&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Schlafer, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University, Department of Dentistry and Oral Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University, Department of Dentistry and Oral Health</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blue covarine</keyword>
  <keyword>numeric analogue scale</keyword>
  <keyword>spectrophotometry</keyword>
  <keyword>tooth bleaching</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760367
org study id: IOOS_TA_01_2018
nct id: NCT03760367
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of two groups - blue covarine toothpaste and control toothpaste group.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: 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.
measure: 3D VITA SYSTEM 3D-MASTER tooth color change
time frame: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.
description: Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
measure: Change of participant satisfaction with the tooth color
time frame: Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.
description: 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).
measure: 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.
description: The change of the blue-yellow color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
measure: 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.
description: The change of the green-red color component of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
measure: 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.
description: The change of lightness of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
measure: Participant evaluation of tooth color change
time frame: The color change of the upper front teeth is assessed once: immediately after toothbrushing.
description: 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).
arm group label: Blue Covarine Toothpaste
arm group type: Experimental
description: 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.
arm group label: Control Toothpaste
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Blue covarine toothpaste
description: 2 min toothbrushing with 1 g of Pepsodent White Now Gold
arm group label: Blue Covarine Toothpaste
other name: Pepsodent White Now Gold
intervention type: Other
intervention name: Control toothpaste
description: 2 min toothbrushing with 1 g of Colgate Advanced Whitening
arm group label: Control Toothpaste
other name: Colgate Advanced Whitening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian Schlafer, Dr.
role: Principal Investigator
affiliation: Aarhus University, Department of Dentistry and Oral Health
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: No
ipd description: 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.