<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/NCT03232255</url>
  </required_header>
  <id_info>
    <org_study_id>100080</org_study_id>
    <nct_id>NCT03232255</nct_id>
  </id_info>
  <brief_title>Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity</brief_title>
  <official_title>Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InQpharm Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InQpharm Group</source>
  <oversight_info>
    <has_dmc>No</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 study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the&#xD;
      treatment of dentine hypersensitivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">December 7, 2017</completion_date>
  <primary_completion_date type="Actual">December 7, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dentine hypersensitivity</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by subjects using VAS</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mouthrinse (IQP-OLP-101)</intervention_name>
    <description>Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least one hypersensitive tooth in everyday life after PAV 1 in-office visit&#xD;
&#xD;
          2. At least one hypersensitive tooth in everyday life with a regular pain perception of&#xD;
             at least 2 times per week after PAV 1 visit&#xD;
&#xD;
          3. At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at&#xD;
             study entry&#xD;
&#xD;
          4. Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute&#xD;
             signs of caries on the exposed root&#xD;
&#xD;
          5. For subjects entering the study at stage PAR-control: good healing of the periodontal&#xD;
             surgery site, cause of pain must not be the result of the periodontal surgery&#xD;
&#xD;
          6. Age ≥ 18 years and ≤ 75 years&#xD;
&#xD;
          7. Willing and able to attend the on-study visits&#xD;
&#xD;
          8. Willing and able to understand and to follow the study procedures and instructions&#xD;
&#xD;
          9. Good oral hygiene throughout the study&#xD;
&#xD;
         10. Written informed consent before participation in the study&#xD;
&#xD;
         11. Subjects have undergone dental hygiene treatment immediately prior to study inclusion&#xD;
             (except subjects entering the study at stage PAR-control)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity only due to sweets&#xD;
&#xD;
          2. Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc&#xD;
             lactate&#xD;
&#xD;
          3. Professional desensitizing therapy during the previous 3 months; GLUMA&#xD;
             (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months&#xD;
&#xD;
          4. Chronic systemic anti-inflammatory and analgesic medications&#xD;
&#xD;
          5. Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating&#xD;
             disorders, etc.)&#xD;
&#xD;
          6. Teeth or supporting structures with any other painful pathology or defect&#xD;
&#xD;
          7. Subject with poor health conditions&#xD;
&#xD;
          8. Concurrent participation in another clinical trial&#xD;
&#xD;
          9. Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Praxisklinik ORS</name>
      <address>
        <city>Fellbach</city>
        <zip>70736</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03232255
org study id: 100080
nct id: NCT03232255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the
      treatment of dentine hypersensitivity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in dentine hypersensitivity
time frame: 28 days
description: Assessed by subjects using VAS
arm group label: Treatment Group
arm group type: Experimental
intervention type: Other
intervention name: Mouthrinse (IQP-OLP-101)
description: Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
sharing ipd: No