<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/NCT03039270</url>
  </required_header>
  <id_info>
    <org_study_id>49123715.1.0000.5020</org_study_id>
    <secondary_id>1.310.594</secondary_id>
    <nct_id>NCT03039270</nct_id>
  </id_info>
  <brief_title>Evaluation of Sensitivity With and Without Sonic Activation of a Desensitizing Gel Before in Office Bleaching in Adults</brief_title>
  <official_title>Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Amazonas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coordination for the Improvement of Higher Education Personnel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Amazonas</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>
      This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted&#xD;
      aiming to assess the absolute risk of sensitivity with and without sonic activation of a&#xD;
      desensitizing gel previously to the in-office bleaching in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial evaluated the effect of sonic activation of a desensitizing gel on the&#xD;
      occurrence of sensitivity associated with office bleaching. For this, 31 patients had their&#xD;
      anterior superior teeth divided into right and left, according to the sonic activation (AS)&#xD;
      or not (SS) of the desensitizer. Prior to bleaching, a desensitizing gel containing 5%&#xD;
      potassium nitrate and 2% sodium fluoride (Desensibilize KF2%, FGM Dental Products,SC, Brazil)&#xD;
      was applied. Sonic activation was performed with a sonic device (Smart, FGM Dental Products,&#xD;
      SC, Brazil) at the 170 MHz frequency. A hydrogen peroxide gel (Whiteness HP Maxx, FGM Dental&#xD;
      Products, SC, Brazil) was used in two whitening sessions. It was also performed, evaluation&#xD;
      of the presence of cracks in enamel, through transillumination. The color change was verified&#xD;
      using two color scales and a spectrophotometer. The dental sensitivity was recorded through a&#xD;
      sensitivity diary answered by the patient, in the period up to 48 hours after each bleaching&#xD;
      session. The absolute risk of tooth sensitivity was compared using the McNemar test (= 5%).&#xD;
      The color change was analyzed from the variation of units of scale vita (SGU) and through the&#xD;
      value of ΔE, which were compared through Student t test (α = 5%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2016</start_date>
  <completion_date type="Actual">April 15, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</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>Randomized, controlled clinical trial, triple-blind, split-mouth type.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Neither the color evaluator nor the statistician were aware of the allocation of the hemiarcs, according to the sonic activation or not of them. In the execution of the intervention, the sonic activation was applied in sites such as marginal gingiva, premolars, palatal face of the teeth, in order to mask the treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute risk of tooth sensitivity</measure>
    <time_frame>Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.</time_frame>
    <description>Number of patients experiencing sensitivity at least once during the two whitening sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleaching effectiveness</measure>
    <time_frame>Measured by the difference between the baseline color and 30 days after the second bleaching session.</time_frame>
    <description>Change of color of teeth after bleaching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain experienced, as measured by two pain scales.</measure>
    <time_frame>Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.</time_frame>
    <description>Intensity of pain experienced</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Dentin Sensitivity</condition>
  <condition>Tooth Bleaching</condition>
  <arm_group>
    <arm_group_label>Control (Without sonic activation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With sonic activation (SMART Device®)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>With sonic activation (SMART Device®)</intervention_name>
    <description>The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM, SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the sonic activation side, immediately after the gel's application, sonic activation(Smart Sonic Device, FGM, SC, Brazil) was performed for 1.5 minutes in total for side (30 seconds per tooth). After the time of 30 seconds in each of the three anterior teeth of the respective side, the gel was removed from teeth with cotton. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.</description>
    <arm_group_label>With sonic activation (SMART Device®)</arm_group_label>
    <other_name>Sonic vibration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control (Without sonic activation)</intervention_name>
    <description>The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM,SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the side allocated for application without sonic activation, gel was kept for 10 minutes, after which it was removed from the teeth. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.</description>
    <arm_group_label>Control (Without sonic activation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients had at least six upper anterior teeth free of caries and restorations on the&#xD;
             vestibular surface, and at least one central or canine incisor showing A2 or darker&#xD;
             coloration, evaluated in comparison with a visual scale of color orientated by the&#xD;
             value of the teeth (Vita Classical, Vita-Zahnfabrik- Germany).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Users of fixed orthodontic appliances, pregnant or lactating, with the presence of&#xD;
             severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and&#xD;
             depolluted teeth), who were taking any medication with action Anti-inflammatory and&#xD;
             antioxidant, using desensitizing dentifrice and participants with previous history of&#xD;
             dental sensitivity or any associated pathology (bruxism, gingival recession,&#xD;
             non-carious lesion with dentin exposure).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Verônica Bertocco</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Amazonas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Federal University of Amazonas</name>
      <address>
        <city>Manaus</city>
        <state>Amazonas</state>
        <zip>69025-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Amazonas</investigator_affiliation>
    <investigator_full_name>Verônica Pereira de Lima Bertocco</investigator_full_name>
    <investigator_title>Graduate student</investigator_title>
  </responsible_party>
  <keyword>Tooth Sensitivity</keyword>
  <keyword>Tooth Bleaching</keyword>
  <keyword>Desensitizing agent</keyword>
  <keyword>Sonic vibration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03039270
org study id: 49123715.1.0000.5020
secondary id: 1.310.594
nct id: NCT03039270
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted
      aiming to assess the absolute risk of sensitivity with and without sonic activation of a
      desensitizing gel previously to the in-office bleaching in adults.
This clinical trial evaluated the effect of sonic activation of a desensitizing gel on the
      occurrence of sensitivity associated with office bleaching. For this, 31 patients had their
      anterior superior teeth divided into right and left, according to the sonic activation (AS)
      or not (SS) of the desensitizer. Prior to bleaching, a desensitizing gel containing 5%
      potassium nitrate and 2% sodium fluoride (Desensibilize KF2%, FGM Dental Products,SC, Brazil)
      was applied. Sonic activation was performed with a sonic device (Smart, FGM Dental Products,
      SC, Brazil) at the 170 MHz frequency. A hydrogen peroxide gel (Whiteness HP Maxx, FGM Dental
      Products, SC, Brazil) was used in two whitening sessions. It was also performed, evaluation
      of the presence of cracks in enamel, through transillumination. The color change was verified
      using two color scales and a spectrophotometer. The dental sensitivity was recorded through a
      sensitivity diary answered by the patient, in the period up to 48 hours after each bleaching
      session. The absolute risk of tooth sensitivity was compared using the McNemar test (= 5%).
      The color change was analyzed from the variation of units of scale vita (SGU) and through the
      value of ΔE, which were compared through Student t test (α = 5%).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled clinical trial, triple-blind, split-mouth type.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Neither the color evaluator nor the statistician were aware of the allocation of the hemiarcs, according to the sonic activation or not of them. In the execution of the intervention, the sonic activation was applied in sites such as marginal gingiva, premolars, palatal face of the teeth, in order to mask the treatment.
measure: Absolute risk of tooth sensitivity
time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
description: Number of patients experiencing sensitivity at least once during the two whitening sessions.
measure: Bleaching effectiveness
time frame: Measured by the difference between the baseline color and 30 days after the second bleaching session.
description: Change of color of teeth after bleaching.
measure: Intensity of pain experienced, as measured by two pain scales.
time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
description: Intensity of pain experienced
arm group label: Control (Without sonic activation)
arm group type: Active Comparator
description: Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.
arm group label: With sonic activation (SMART Device®)
arm group type: Experimental
description: Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching.
intervention type: Other
intervention name: With sonic activation (SMART Device®)
description: The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM, SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the sonic activation side, immediately after the gel's application, sonic activation(Smart Sonic Device, FGM, SC, Brazil) was performed for 1.5 minutes in total for side (30 seconds per tooth). After the time of 30 seconds in each of the three anterior teeth of the respective side, the gel was removed from teeth with cotton. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
arm group label: With sonic activation (SMART Device®)
other name: Sonic vibration
intervention type: Other
intervention name: Control (Without sonic activation)
description: The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM,SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the side allocated for application without sonic activation, gel was kept for 10 minutes, after which it was removed from the teeth. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
arm group label: Control (Without sonic activation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Verônica Bertocco
role: Principal Investigator
affiliation: Federal University of Amazonas
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Amazonas
investigator full name: Verônica Pereira de Lima Bertocco
investigator title: Graduate student
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
sharing ipd: No