<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/NCT01700348</url>
  </required_header>
  <id_info>
    <org_study_id>MAH-12-0081</org_study_id>
    <secondary_id>10438</secondary_id>
    <nct_id>NCT01700348</nct_id>
  </id_info>
  <brief_title>Philips AirFlosser Study</brief_title>
  <official_title>An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Oral Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual&#xD;
      Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and&#xD;
      who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No&#xD;
      Intervention group and will be given no test products or instruction other than to change&#xD;
      none of their typical at home oral hygiene habits.&#xD;
&#xD;
      The aim of this study is to investigate how an AF and MTB oral hygiene intervention will&#xD;
      affect a population of irregular flossers using the residual protein concentration method as&#xD;
      an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the&#xD;
      Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated by financier due to low accrual &amp; high number of protocol deviations.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group</measure>
    <time_frame>Four Months</time_frame>
    <description>The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival Inflammation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Bleeding Sites</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>4 Months</time_frame>
    <description>Assess the safety of the Sonicare AirFloss + MTB treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Bleeding Sites</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">257</enrollment>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Airflosser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Airflosser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Floss</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal Routine</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Airflosser</intervention_name>
    <description>Use of Philips Airflosser</description>
    <arm_group_label>Airflosser</arm_group_label>
    <other_name>Philips Airflosser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual Floss</intervention_name>
    <description>Active Comparator</description>
    <arm_group_label>Manual Floss</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        4.1 Inclusion Criteria&#xD;
&#xD;
        Subjects accepted into the study must meet the following requirements:&#xD;
&#xD;
          -  are 18-70 years;&#xD;
&#xD;
          -  are in generally good health;&#xD;
&#xD;
          -  have a minimum of 20 natural teeth (excluding 3rd molars);&#xD;
&#xD;
          -  have 1 qualifying test site in each posterior quadrant;&#xD;
&#xD;
          -  are a regular manual toothbrush user (prior periodic use of powered toothbrushes in&#xD;
             other studies permitted);&#xD;
&#xD;
          -  Irregular Flossers defined as using dental floss ≤ 2 days a week;&#xD;
&#xD;
          -  be willing and able to comply with study procedures and be available at all times&#xD;
             required for participation;&#xD;
&#xD;
          -  have a Gingival Bleeding Index &gt; 1 on at least 20 sites;&#xD;
&#xD;
          -  be a non-smoker.&#xD;
&#xD;
        4.2 Exclusion Criteria Subjects will be excluded from the study if they;&#xD;
&#xD;
          -  have systemic diseases such as Down's syndrome, or known AIDS/HIV;&#xD;
&#xD;
          -  have insulin dependent Diabetes;&#xD;
&#xD;
          -  are pregnant or nursing by subject report;&#xD;
&#xD;
          -  have a cardiac pacemaker or AICD;&#xD;
&#xD;
          -  are undergoing or require extensive dental or orthodontic treatment;&#xD;
&#xD;
          -  require antibiotic treatment for dental appointments;&#xD;
&#xD;
          -  have used antibiotics within 4 weeks of enrollment;&#xD;
&#xD;
          -  are currently using prescription-dose anti-inflammatory medications or anticoagulants&#xD;
             (including aspirin);&#xD;
&#xD;
          -  have heavy deposits of calculus, either supragingival and/or subgingival;&#xD;
&#xD;
          -  have severe gingivitis or periodontitis;&#xD;
&#xD;
          -  have extensive crown or bridge work and/or rampant decay;&#xD;
&#xD;
          -  are currently use bleaching trays;&#xD;
&#xD;
          -  have any oral or extraoral piercing on lips or in mouth with ornament or accessory;&#xD;
&#xD;
          -  have a professional prophylaxis within 4 weeks of study;&#xD;
&#xD;
          -  have participated in a prior study ≤ 20 days;&#xD;
&#xD;
          -  are employed by an oral healthcare products company or dental research institution.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard Kugel, DMD, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TUSDM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts University School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>February 26, 2015</results_first_submitted>
  <results_first_submitted_qc>May 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 29, 2015</results_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>moderate gingivitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 257 subjects who signed consent forms, 140 (54.5% were classified as screen failures). 1 additional subject declined to participate after screening but before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Enrolled Subjects</title>
          <description>Airflosser &amp; Manual Floss</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data cannot be provided for each arm separately, but only in aggregate</population>
      <group_list>
        <group group_id="B1">
          <title>All Randomized Subjects</title>
          <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="116"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="34.5" spread="11.20"/>
                  </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="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </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="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Missing Teeth</title>
          <units>missing teeth</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".8" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average Modified Gingival Index Score</title>
          <description>The Modified Gingival Index (MGI) scale 0 = absence of inflammation;&#xD;
= mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;&#xD;
= mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;&#xD;
= moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;&#xD;
= severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.2" spread=".4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Bleeding Sites</title>
          <units>number of sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.1" spread="17.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent of Site Bleeding</title>
          <units>percent of sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.6" spread="16.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group</title>
        <description>The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.</description>
        <time_frame>Four Months</time_frame>
        <population>Terminated by financier due to low accrual &amp; high number of protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed.&quot;</description>
          </group>
        </group_list>
        <measure>
          <title>The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group</title>
          <description>The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.</description>
          <population>Terminated by financier due to low accrual &amp; high number of protocol deviations.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gingival Inflammation</title>
        <description>Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.</description>
        <time_frame>4 weeks</time_frame>
        <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</description>
          </group>
        </group_list>
        <measure>
          <title>Gingival Inflammation</title>
          <description>Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.</description>
          <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Bleeding Sites</title>
        <description>Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
        <time_frame>2 Weeks</time_frame>
        <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Bleeding Sites</title>
          <description>Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
          <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plaque</title>
        <description>Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.</description>
          </group>
        </group_list>
        <measure>
          <title>Plaque</title>
          <description>Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.</description>
          <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
        <description>Assess the safety of the Sonicare AirFloss + MTB treatment.</description>
        <time_frame>4 Months</time_frame>
        <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
          <description>Assess the safety of the Sonicare AirFloss + MTB treatment.</description>
          <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Bleeding Sites</title>
        <description>Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
        <time_frame>2 Weeks</time_frame>
        <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Randomized Subjects</title>
            <description>The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Bleeding Sites</title>
          <description>Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.</description>
          <population>The study was terminated early, data were not analyzed and the plaque samples were destroyed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>All Randomized Subjects</title>
          <description>Summary of AEs for All Randomized Subjects</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="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Terminated by sponsor due to:&#xD;
Changes in business strategy/Target completion dates not being met&#xD;
Higher than anticipated screen failure rate&#xD;
Higher than anticipated early termination rate&#xD;
Large number of protocol deviations encountered</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marcia Delaurenti, Clinical Project Manager</name_or_title>
      <organization>Philips Oral Healthcare, Inc</organization>
      <phone>425-908-1212</phone>
      <email>marcia.delaurenti@philips.com</email>
    </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/NCT01700348
org study id: MAH-12-0081
secondary id: 10438
nct id: NCT01700348
lead sponsor: 
collaborator: 
has dmc: No
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual
      Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and
      who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No
      Intervention group and will be given no test products or instruction other than to change
      none of their typical at home oral hygiene habits.

      The aim of this study is to investigate how an AF and MTB oral hygiene intervention will
      affect a population of irregular flossers using the residual protein concentration method as
      an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the
      Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
time frame: Four Months
description: The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.
measure: Gingival Inflammation
time frame: 4 weeks
description: Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.
measure: Number of Bleeding Sites
time frame: 2 Weeks
description: Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
measure: Plaque
time frame: 4 Weeks
description: Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: 4 Months
description: Assess the safety of the Sonicare AirFloss + MTB treatment.
measure: Percentage of Bleeding Sites
time frame: 2 Weeks
description: Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
arm group label: Airflosser
arm group type: Experimental
description: Use of Airflosser
arm group label: Manual Floss
arm group type: Active Comparator
description: Normal Routine
intervention type: Device
intervention name: Airflosser
description: Use of Philips Airflosser
arm group label: Airflosser
other name: Philips Airflosser
intervention type: Device
intervention name: Manual Floss
description: Active Comparator
arm group label: Manual Floss
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerard Kugel, DMD, MS, PhD
role: Principal Investigator
affiliation: TUSDM
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gingivitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Terminated by sponsor due to:
Changes in business strategy/Target completion dates not being met
Higher than anticipated screen failure rate
Higher than anticipated early termination rate
Large number of protocol deviations encountered
point of contact: 