<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/NCT02187016</url>
  </required_header>
  <id_info>
    <org_study_id>MAH-13-0151</org_study_id>
    <nct_id>NCT02187016</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health</brief_title>
  <official_title>A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Oral Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Oral Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal&#xD;
      cleaning modalities with and without chemistry on oral health over 28 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">290</enrollment>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>AirFloss + BreathRx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AirFloss + Listerine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dental Floss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Toothbrush</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AirFloss + BreathRx</intervention_name>
    <description>Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.</description>
    <arm_group_label>AirFloss + BreathRx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AirFloss + Listerine</intervention_name>
    <description>Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.</description>
    <arm_group_label>AirFloss + Listerine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental Floss</intervention_name>
    <description>Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.</description>
    <arm_group_label>Dental Floss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual Toothbrush</intervention_name>
    <description>Manual Toothbrush used twice daily, 1 minute.</description>
    <arm_group_label>Manual Toothbrush</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing and physically able to carry out all study procedures and be available at&#xD;
             all times required for participation&#xD;
&#xD;
          -  Be able to fully understand and comply with the written and verbal instructions&#xD;
             provided&#xD;
&#xD;
          -  Provide written Informed Consent&#xD;
&#xD;
          -  Be age 18 - 65 years&#xD;
&#xD;
          -  Agree to return study materials at the required visits&#xD;
&#xD;
          -  Be a non-smoker&#xD;
&#xD;
          -  Have a minimum of 20 'scorable' teeth (excluding 3rd molars)&#xD;
&#xD;
          -  Have a minimum average plaque score of &gt; 0.5 per RMNPI scoring with 2-6 hours of&#xD;
             plaque accumulation&#xD;
&#xD;
          -  Have a Gingival Bleeding Index of -&gt;1 on at least 10 sites&#xD;
&#xD;
          -  Be a regular manual toothbrush user&#xD;
&#xD;
          -  Be a non or irregular flosser defined as using dental floss or any other interproximal&#xD;
             cleaning technique once per week or less often&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical or dental condition that would be unduly affected by participation in this&#xD;
             study, per Investigator discretion&#xD;
&#xD;
          -  Pregnant or nursing per subject report&#xD;
&#xD;
          -  A medical condition requiring antibiotic pre-medication prior to dental appointments&#xD;
&#xD;
          -  Diagnosis of xerostomia&#xD;
&#xD;
          -  Any oral or extra oral piercing that interferes with the ability to perform study&#xD;
             procedures and/or clinical assessments in the mouth&#xD;
&#xD;
          -  Currently undergoing or requiring dental/periodontal treatment, or having had&#xD;
             periodontal treatment in the six months preceding the study, where the subject's study&#xD;
             participation could present an undue safety risk or obscure the evaluation of study&#xD;
             endpoints, per Investigator /Examiner discretion&#xD;
&#xD;
          -  Oral surgery within the last 2 months&#xD;
&#xD;
          -  Current use of professionally dispensed bleaching products&#xD;
&#xD;
          -  A known allergy or sensitivity to products planned for use in this study&#xD;
&#xD;
          -  Unwillingness to abstain from all other oral hygiene products other than those&#xD;
             prescribed for the duration of the study&#xD;
&#xD;
          -  Unwillingness to abstain from all other oral hygiene products other than those&#xD;
             prescribed for the duration of the study&#xD;
&#xD;
          -  Participation in an oral care study within the previous 90 days&#xD;
&#xD;
          -  Be an employee or a relative of an employee of the Site clinical research department,&#xD;
             dental school, or a dental products manufacturing, research or marketing firm&#xD;
&#xD;
          -  Are a dental student or dental professional&#xD;
&#xD;
          -  A cardiac pacemaker or implanted cardiac defibrillator&#xD;
&#xD;
          -  Insulin-Dependent Diabetes&#xD;
&#xD;
          -  Current use of antibiotic medications or use within 4 weeks of enrollment&#xD;
&#xD;
          -  Current use of prescription-dose anti-inflammatory medications or anticoagulants;&#xD;
             (including aspirin &gt; 81 mg daily)&#xD;
&#xD;
          -  Presence of advanced periodontal disease or excessive gingival recession, per&#xD;
             Investigator/Examiner discretion&#xD;
&#xD;
          -  Heavy deposits of calculus, either supragingival and/or subgingival, per&#xD;
             Investigator/Examiner discretion&#xD;
&#xD;
          -  Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner&#xD;
             discretion&#xD;
&#xD;
          -  Presence of orthodontic bands interfering with efficacy outcome(s) per&#xD;
             Investigator/Examiner discretion&#xD;
&#xD;
          -  Have a professional prophylaxis within 4 weeks of the study&#xD;
&#xD;
          -  Be a regular power toothbrush user&#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>
  <overall_official>
    <last_name>Pejmon Amini, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Silverston Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Silverstone Research Group</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>November 23, 2015</results_first_submitted>
  <results_first_submitted_qc>November 23, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 29, 2015</results_first_posted>
  <last_update_submitted>February 5, 2016</last_update_submitted>
  <last_update_submitted_qc>February 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gingivitis</keyword>
  <keyword>plaque</keyword>
  <keyword>interproximal cleaning</keyword>
  <keyword>dental floss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AirFloss + Rinse1</title>
          <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="P2">
          <title>AirFloss + Rinse2</title>
          <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="P3">
          <title>String Floss</title>
          <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
        </group>
        <group group_id="P4">
          <title>Manual Toothbrush</title>
          <description>Manual Toothbrush is used twice a day for 1 minute</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="79"/>
                <participants group_id="P4" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="78"/>
                <participants group_id="P4" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AirFloss + Rinse1</title>
          <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="B2">
          <title>AirFloss + Rinse2</title>
          <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="B3">
          <title>String Floss</title>
          <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
        </group>
        <group group_id="B4">
          <title>Manual Toothbrush</title>
          <description>Manual Toothbrush is used twice a day for 1 minute</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="79"/>
            <count group_id="B4" value="51"/>
            <count group_id="B5" value="287"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37" spread="12.20"/>
                    <measurement group_id="B2" value="35.6" spread="10.70"/>
                    <measurement group_id="B3" value="34.9" spread="11.00"/>
                    <measurement group_id="B4" value="35.1" spread="12.10"/>
                    <measurement group_id="B5" value="35.7" spread="11.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14</title>
        <description>MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14</title>
          <description>MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.01"/>
                    <measurement group_id="O2" value="0.10" spread="0.01"/>
                    <measurement group_id="O3" value="0.10" spread="0.01"/>
                    <measurement group_id="O4" value="0.01" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28</title>
        <description>MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28</title>
          <description>MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.01"/>
                    <measurement group_id="O2" value="0.22" spread="0.01"/>
                    <measurement group_id="O3" value="0.26" spread="0.01"/>
                    <measurement group_id="O4" value="0.03" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14</title>
        <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14</title>
          <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.00"/>
                    <measurement group_id="O2" value="0.05" spread="0.00"/>
                    <measurement group_id="O3" value="0.05" spread="0.00"/>
                    <measurement group_id="O4" value="0.00" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28</title>
        <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28</title>
          <description>GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.00"/>
                    <measurement group_id="O2" value="0.08" spread="0.00"/>
                    <measurement group_id="O3" value="0.09" spread="0.00"/>
                    <measurement group_id="O4" value="0.01" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14</title>
        <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14</title>
          <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.01"/>
                    <measurement group_id="O2" value="0.10" spread="0.01"/>
                    <measurement group_id="O3" value="0.11" spread="0.01"/>
                    <measurement group_id="O4" value="0.04" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28</title>
        <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AirFloss + Rinse1</title>
            <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O2">
            <title>AirFloss + Rinse2</title>
            <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
          </group>
          <group group_id="O3">
            <title>String Floss</title>
            <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
          </group>
          <group group_id="O4">
            <title>Manual Toothbrush</title>
            <description>Manual Toothbrush is used twice a day for 1 minute</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28</title>
          <description>RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.01"/>
                    <measurement group_id="O2" value="0.16" spread="0.01"/>
                    <measurement group_id="O3" value="0.17" spread="0.01"/>
                    <measurement group_id="O4" value="0.04" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Oral changes from baseline evaluated at Day 14 and 28</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AirFloss + Rinse1</title>
          <description>AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="E2">
          <title>AirFloss + Rinse2</title>
          <description>AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.</description>
        </group>
        <group group_id="E3">
          <title>String Floss</title>
          <description>String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute</description>
        </group>
        <group group_id="E4">
          <title>Manual Toothbrush</title>
          <description>Manual Toothbrush is used twice a day for 1 minute</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gingival Irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pejjmon Amini, DMD</name_or_title>
      <organization>Silverstone Research Group</organization>
      <phone>702-901-444</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT02187016
org study id: MAH-13-0151
nct id: NCT02187016
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal
      cleaning modalities with and without chemistry on oral health over 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
time frame: 14 days
description: MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
measure: Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
time frame: 28 days
description: MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
measure: Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
time frame: 14 days
description: GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
measure: Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
time frame: 28 days
description: GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
measure: Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
time frame: 14 days
description: RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
measure: Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
time frame: 28 days
description: RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
arm group label: AirFloss + BreathRx
arm group type: Experimental
description: Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day.
arm group label: AirFloss + Listerine
arm group type: Experimental
description: Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day.
arm group label: Dental Floss
arm group type: Experimental
description: Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.
arm group label: Manual Toothbrush
arm group type: Active Comparator
description: Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute
intervention type: Device
intervention name: AirFloss + BreathRx
description: Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
arm group label: AirFloss + BreathRx
intervention type: Device
intervention name: AirFloss + Listerine
description: Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
arm group label: AirFloss + Listerine
intervention type: Device
intervention name: Dental Floss
description: Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
arm group label: Dental Floss
intervention type: Device
intervention name: Manual Toothbrush
description: Manual Toothbrush used twice daily, 1 minute.
arm group label: Manual Toothbrush
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pejmon Amini, DDS
role: Principal Investigator
affiliation: Silverston Research Group
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Listerine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 