<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/NCT02987634</url>
  </required_header>
  <id_info>
    <org_study_id>PORPIS</org_study_id>
    <nct_id>NCT02987634</nct_id>
  </id_info>
  <brief_title>Evaluation and Comparison of Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Mouth Rinse</brief_title>
  <official_title>Phase IV Study to Evaluate and Compare the Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Rinse With Regards to Managing Post-surgical Inflammation Associated With Dental Implant Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izun Pharma Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jerusalem Perio Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herzog Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Izun Pharma Ltd</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of Sambucus&#xD;
      nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival inflammation&#xD;
      in an experimental gingivitis model in a phase II study, as well as in numerous other&#xD;
      clinical trials. The product and its individual components were shown to be safe.&#xD;
&#xD;
      Based on these favorable results, Izun is now seeking to demonstrate that a combined&#xD;
      anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and&#xD;
      reduce localized inflammation following dental implant surgery equal to, or better than, a&#xD;
      chlorhexidine rinse, with fewer side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized phase IV controlled trial with two parallel arms: (1) PeriActive rinse&#xD;
      and (2) Chlorhexidine 0.12% rinse. Subjects will be randomized to one of two treatment groups&#xD;
      at the time of implant surgery. An alternating 1:1 randomization scheme will be used, with&#xD;
      the first patient receiving Chlorhexidine, the second patient receiving PeriActive, the third&#xD;
      patient receiving Chlorhexidine and so forth.&#xD;
&#xD;
      Implant surgery will require an incision and tissue reflection. Implant(s) will be placed at&#xD;
      bone level (+/- 2 mm). The abutment placed will be transgingival at least 2 mm above soft&#xD;
      tissue level. Tissues will be sutured with 6-0 ePTFE (Goretex) sutures, as needed.&#xD;
      Antibiotics will be prescribed for 7 days following surgery. In addition, at the end of the&#xD;
      surgical visit, the patient will be issued two bottles of the assigned rinse which will be&#xD;
      used twice each day.&#xD;
&#xD;
      Details of Study Visits Screening/Visit 1 - Day 0 Following signing of informed consent form,&#xD;
      adult male and female subjects aged ≥18 years will be screened for study eligibility by&#xD;
      assessment of inclusion and exclusion criteria. Screening procedures will include collection&#xD;
      of demographic data and medical history. Eligible subjects will then undergo implant surgery,&#xD;
      and relevant indices will be measured. Subjects will then be instructed in how to rinse with&#xD;
      the relevant oral rinse and be given two bottles for the remainder of the study.&#xD;
&#xD;
      Visits 2 and 3 - 2 and 4 weeks (± 3 days) post-surgery, respectively At visit 2, sutures will&#xD;
      be removed and a light curetting of the sites (as needed) will be performed, followed by&#xD;
      evaluation for Gingival Index (GI; modified for incision), Plaque Index (PI) and compliance&#xD;
      with protocol. At visit 3, only clinical indices and compliance with protocol with be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GI at buccal margin of implant</measure>
    <time_frame>2-4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>GI at margin of flap adjacent to implant</measure>
    <time_frame>2-4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>PeriActive mouthwash</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient is directed to rinse twice a day for 4 weeks. each rinse is 15 ml of Periactive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chlorhexidine 0.12% mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient is directed to rinse twice a day for 4 weeks. each rinse is 10 ml of Periactive</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PeriActive</intervention_name>
    <description>mouthwash</description>
    <arm_group_label>PeriActive mouthwash</arm_group_label>
    <arm_group_label>chlorhexidine 0.12% mouthwash</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be adult males or females over the age of 18 years.&#xD;
&#xD;
          2. Subjects must be able and willing to follow study procedures and instructions.&#xD;
&#xD;
          3. Subjects must present with the need for implant surgery that would necessitate&#xD;
             surgical incision (flap elevation) and transgingival implant healing cap, be available&#xD;
             for follow-up visits and be able to follow rinse protocol instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who exhibit gross oral pathology and severe gingival inflammation at the time&#xD;
             of surgery at the projected surgical site.&#xD;
&#xD;
          2. Subjects chronically treated (i.e., ≥ two weeks) with anti-inflammatory medications&#xD;
             (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to&#xD;
             affect gingival tissue status (e.g., phenytoin, cyclosporine) within one month of the&#xD;
             screening examination. Prophylactic use of aspirin ( 81 mg daily) and Plavix when used&#xD;
             for cardiovascular indications will be permitted (a note should be inserted into&#xD;
             patient's documentation) and any therapeutic treatment modifications will be under the&#xD;
             jurisdiction of the treating dentist. All other medications for chronic medical&#xD;
             conditions should be initiated at least three months prior to enrollment.&#xD;
&#xD;
          3. Subjects with active infectious diseases such as hepatitis, human immunodeficiency&#xD;
             virus (HIV) or tuberculosis&#xD;
&#xD;
          4. Subjects with Types I or II diabetes, thyroid disease or cancer chemotherapy&#xD;
&#xD;
          5. Subjects reporting allergies to the constituents in the rinse&#xD;
&#xD;
          6. Female subjects who report being pregnant or lactating&#xD;
&#xD;
          7. Subjects with clinically significant laboratory results&#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_contact>
    <last_name>Meirav Raz</last_name>
    <phone>972-72-245-6199</phone>
    <email>mraz@izunpharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Motti Levinson</last_name>
    <phone>972-72-2458950</phone>
    <email>motti@izunpharma.com</email>
  </overall_contact_backup>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gingivitis</keyword>
  <keyword>dental implant</keyword>
  <keyword>mouthwash</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>trial results will be published for dentists to see</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/NCT02987634
org study id: PORPIS
nct id: NCT02987634
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of Sambucus
      nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival inflammation
      in an experimental gingivitis model in a phase II study, as well as in numerous other
      clinical trials. The product and its individual components were shown to be safe.

      Based on these favorable results, Izun is now seeking to demonstrate that a combined
      anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and
      reduce localized inflammation following dental implant surgery equal to, or better than, a
      chlorhexidine rinse, with fewer side effects.
This is a randomized phase IV controlled trial with two parallel arms: (1) PeriActive rinse
      and (2) Chlorhexidine 0.12% rinse. Subjects will be randomized to one of two treatment groups
      at the time of implant surgery. An alternating 1:1 randomization scheme will be used, with
      the first patient receiving Chlorhexidine, the second patient receiving PeriActive, the third
      patient receiving Chlorhexidine and so forth.

      Implant surgery will require an incision and tissue reflection. Implant(s) will be placed at
      bone level (+/- 2 mm). The abutment placed will be transgingival at least 2 mm above soft
      tissue level. Tissues will be sutured with 6-0 ePTFE (Goretex) sutures, as needed.
      Antibiotics will be prescribed for 7 days following surgery. In addition, at the end of the
      surgical visit, the patient will be issued two bottles of the assigned rinse which will be
      used twice each day.

      Details of Study Visits Screening/Visit 1 - Day 0 Following signing of informed consent form,
      adult male and female subjects aged ≥18 years will be screened for study eligibility by
      assessment of inclusion and exclusion criteria. Screening procedures will include collection
      of demographic data and medical history. Eligible subjects will then undergo implant surgery,
      and relevant indices will be measured. Subjects will then be instructed in how to rinse with
      the relevant oral rinse and be given two bottles for the remainder of the study.

      Visits 2 and 3 - 2 and 4 weeks (± 3 days) post-surgery, respectively At visit 2, sutures will
      be removed and a light curetting of the sites (as needed) will be performed, followed by
      evaluation for Gingival Index (GI; modified for incision), Plaque Index (PI) and compliance
      with protocol. At visit 3, only clinical indices and compliance with protocol with be
      evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: GI at buccal margin of implant
time frame: 2-4 weeks
measure: GI at margin of flap adjacent to implant
time frame: 2-4 weeks
arm group label: PeriActive mouthwash
arm group type: Experimental
description: patient is directed to rinse twice a day for 4 weeks. each rinse is 15 ml of Periactive
arm group label: chlorhexidine 0.12% mouthwash
arm group type: Active Comparator
description: patient is directed to rinse twice a day for 4 weeks. each rinse is 10 ml of Periactive
intervention type: Other
intervention name: PeriActive
description: mouthwash
arm group label: PeriActive mouthwash
arm group label: chlorhexidine 0.12% mouthwash
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meirav Raz
phone: 972-72-245-6199
email: mraz@izunpharma.com
last name: Motti Levinson
phone: 972-72-2458950
email: motti@izunpharma.com
responsible party type: Sponsor
mesh term: Periodontal Diseases
sharing ipd: No
ipd description: trial results will be published for dentists to see