<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/NCT01718912</url>
  </required_header>
  <id_info>
    <org_study_id>OVTRI</org_study_id>
    <secondary_id>TRI</secondary_id>
    <nct_id>NCT01718912</nct_id>
  </id_info>
  <brief_title>Periodontal Disease Treatment of a Physically Challenged Population</brief_title>
  <acronym>PDT</acronym>
  <official_title>The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oravital Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oravital Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many physically handicapped patients at the dental department, Toronto Rehabilitation&#xD;
      Institute(TRI) have considerable gingival inflammation and breath odour because of the&#xD;
      inability to effectively handle a toothbrush. These patients have considerable periodontal&#xD;
      disease. There is a concern that these pathogens may have a detrimental effect on wound&#xD;
      healing in other areas of the body.&#xD;
&#xD;
      Hypothesis: Patients attending the dental department at TRI that are treated with the&#xD;
      antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial&#xD;
      decrease in periodontal disease as measured by bleeding points and pocket depth when compared&#xD;
      to the group that continues to use their regular oral hygiene methods (control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of healing of periodontal tissues as shown by a reduction of bleeding</measure>
    <time_frame>two weeks</time_frame>
    <description>Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Periodontal Disease</condition>
  <arm_group>
    <arm_group_label>Metronidazole-nystatin oral rinse, regular oral hygiene</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metronidazole-nystatin oral rinse</intervention_name>
    <arm_group_label>Metronidazole-nystatin oral rinse, regular oral hygiene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must be between the ages of 18 to 65 years Participants must have at least 6&#xD;
        teeth. Participants must have some indication of gingivitis and periodontal breakdown. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or&#xD;
        chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can&#xD;
        be a participant&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Toronto Rehabilitation Institute, Dental Department</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>periodontal disease</keyword>
  <keyword>bleeding on probing</keyword>
  <keyword>periodontal pockets</keyword>
  <keyword>disabled</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Nystatin</mesh_term>
  </intervention_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/NCT01718912
org study id: OVTRI
secondary id: TRI
nct id: NCT01718912
lead sponsor: 
has dmc: No
Many physically handicapped patients at the dental department, Toronto Rehabilitation
      Institute(TRI) have considerable gingival inflammation and breath odour because of the
      inability to effectively handle a toothbrush. These patients have considerable periodontal
      disease. There is a concern that these pathogens may have a detrimental effect on wound
      healing in other areas of the body.

      Hypothesis: Patients attending the dental department at TRI that are treated with the
      antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial
      decrease in periodontal disease as measured by bleeding points and pocket depth when compared
      to the group that continues to use their regular oral hygiene methods (control group).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Evidence of healing of periodontal tissues as shown by a reduction of bleeding
time frame: two weeks
description: Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.
arm group label: Metronidazole-nystatin oral rinse, regular oral hygiene
arm group type: Other
description: Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.
intervention type: Drug
intervention name: metronidazole-nystatin oral rinse
arm group label: Metronidazole-nystatin oral rinse, regular oral hygiene
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Periodontal Diseases
mesh term: Metronidazole
mesh term: Nystatin
sharing ipd: No