<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/NCT03750955</url>
  </required_header>
  <id_info>
    <org_study_id>SITE00000993</org_study_id>
    <nct_id>NCT03750955</nct_id>
  </id_info>
  <brief_title>Induced Gingivitis &amp; Intra-oral Imaging</brief_title>
  <official_title>Induced Gingivitis &amp; Intra-oral Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colgate Palmolive</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using an experimental, non-invasive intra-oral imaging device, this study evaluates the&#xD;
      effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two&#xD;
      weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated&#xD;
      as oral hygiene is resumed and the gingival tissue returns to health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis&#xD;
      induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.&#xD;
&#xD;
      The intervention will consist of cessation of oral hygiene versus an active control of oral&#xD;
      hygiene with a fluoridated toothpaste. This study is a modification of classical experimental&#xD;
      gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant&#xD;
      to the intervention, while the other sextant will serve as control in a split-mouth design of&#xD;
      localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model&#xD;
      (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral&#xD;
      environment by leading to reversible inflammation of the gingival tissues. The purpose of&#xD;
      this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an&#xD;
      innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</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>
    <intervention_model_description>Split-mouth</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.</measure>
    <time_frame>Baseline to Day 14</time_frame>
    <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.</measure>
    <time_frame>Day 14 to Day 28</time_frame>
    <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.</measure>
    <time_frame>Baseline to Day 14</time_frame>
    <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.</measure>
    <time_frame>Day 14 to Day 28</time_frame>
    <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Angiogenesis Chemokine Concentration at Day 28</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Plaque Induced Gingivitis</condition>
  <arm_group>
    <arm_group_label>Plaque induced gingivitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral hygiene maintenance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Plaque induced gingivitis</intervention_name>
    <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
    <arm_group_label>Plaque induced gingivitis</arm_group_label>
    <other_name>Cessation of oral hygiene</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oral hygiene maintenance</intervention_name>
    <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
    <arm_group_label>Oral hygiene maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good general health, ASA I&#xD;
&#xD;
          -  No clinical signs of gingival inflammation at &gt;90% sites observed&#xD;
&#xD;
          -  Probing Depth(PD) ≤ 3.0 mm&#xD;
&#xD;
          -  Attachment Loss (AL) = 0 mm&#xD;
&#xD;
          -  Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on&#xD;
             probing (BOP)(-)&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Medical condition which requires premedication prior to dental treatments/visits&#xD;
&#xD;
               -  Subjects unable or unwilling to undergo informed consent process.&#xD;
&#xD;
               -  Subjects currently using anti-gingivitis oral rinses (washout period of 1 week)&#xD;
&#xD;
               -  History of periodontal disease&#xD;
&#xD;
               -  History of systemic inflammatory or immune conditions&#xD;
&#xD;
               -  Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment&#xD;
&#xD;
               -  Pregnant or breastfeeding at time of screening&#xD;
&#xD;
               -  Concurrent orthodontic treatment&#xD;
&#xD;
               -  Untreated carious lesions and/or inadequate restorations, implants, crowns on&#xD;
                  maxillary non-molar teeth&#xD;
&#xD;
               -  Participation in any other clinical study or test panel within 1 week prior to&#xD;
                  enrollment into this study&#xD;
&#xD;
               -  Use of tobacco products&#xD;
&#xD;
               -  Subjects who must receive dental treatment during the study dates&#xD;
&#xD;
               -  Orthodontic bands, appliances, or crowns and bridges, or removable partial&#xD;
                  dentures affecting the non-molar maxillary teeth&#xD;
&#xD;
               -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard P Darveau, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington School of Dentistry</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>January 6, 2021</results_first_submitted>
  <results_first_submitted_qc>March 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2021</results_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Richard Darveau</investigator_full_name>
    <investigator_title>Professor, School of Dentistry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03750955/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Plaque Induced Gingivitis</title>
          <description>Plaque induced gingivitis resulting from a cessation of oral hygiene in maxillary sextant right (teeth #5 to #8) or left (#9 to #12) using a stent-induced biofilm overgrowth (SIBO) model.</description>
        </group>
        <group group_id="P2">
          <title>Oral Hygiene Maintenance</title>
          <description>Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Hygiene Phase of 2 Weeks</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16">No intervention during the hygiene phase.</participants>
                <participants group_id="P2" count="16">No intervention during the hygiene phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not eligible at Baseline (start of gingivitis induction phase)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Gingivitis Induction Phase of 2 Weeks</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13">6 participants randomized to L maxillary sextant SIBO; 7 randomized to R maxillary sextant SIBO.</participants>
                <participants group_id="P2" count="13">6 randomized to R max. sextant oral hygiene maintenance (OHM); 7 randomized to L max. sextant OHM.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Resolution Phase of 2 Weeks</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13">No stent in use; oral hygiene resumed.</participants>
                <participants group_id="P2" count="13">Oral hygiene maintenance continued.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Plaque Induced Gingivitis</title>
          <description>Plaque induced gingivitis resulting from a cessation of oral hygiene in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant using a stent-induced biofilm overgrowth model.</description>
        </group>
        <group group_id="B2">
          <title>Oral Hygiene Maintenance</title>
          <description>Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.</description>
        </group>
        <group group_id="B3">
          <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="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="13"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>L(left) and R(right) Maxillary sextant</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.3" lower_limit="20" upper_limit="33"/>
                    <measurement group_id="B2" value="23.3" lower_limit="20" upper_limit="33"/>
                    <measurement group_id="B3" value="23.3" lower_limit="20" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>American Indian or Alaska Native, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported, Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported, Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gingival Index</title>
          <description>Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.085" spread="0.3"/>
                    <measurement group_id="B2" value="0.055" spread="0.3"/>
                    <measurement group_id="B3" value="0.077" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visible Plaque Index</title>
          <description>Scoring: 0 = no plaque; 1 = visible plaque</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.078" spread="0.3"/>
                    <measurement group_id="B2" value="0.05" spread="0.2"/>
                    <measurement group_id="B3" value="0.067" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiogenesis chemokine - angiopoietin-1</title>
          <units>picograms/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="141213.37" spread="338487.23"/>
                    <measurement group_id="B2" value="165053.91" spread="408314.93"/>
                    <measurement group_id="B3" value="153133.62" spread="367653.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.</title>
        <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
        <time_frame>Baseline to Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Induced Gingivitis</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.&#xD;
Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
          </group>
          <group group_id="O2">
            <title>Oral Hygiene Maintenance</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.&#xD;
Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.</title>
          <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.2"/>
                    <measurement group_id="O2" value="0.15" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.</title>
        <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
        <time_frame>Day 14 to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Induced Gingivitis</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.&#xD;
Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
          </group>
          <group group_id="O2">
            <title>Oral Hygiene Maintenance</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.&#xD;
Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.</title>
          <description>The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.4"/>
                    <measurement group_id="O2" value="0.08" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.</title>
        <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
        <time_frame>Baseline to Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Induced Gingivitis</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.&#xD;
Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
          </group>
          <group group_id="O2">
            <title>Oral Hygiene Maintenance</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.&#xD;
Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.</title>
          <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="1.4"/>
                    <measurement group_id="O2" value="0.17" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.</title>
        <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
        <time_frame>Day 14 to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Induced Gingivitis</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.&#xD;
Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
          </group>
          <group group_id="O2">
            <title>Oral Hygiene Maintenance</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.&#xD;
Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.</title>
          <description>The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.&#xD;
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.18"/>
                    <measurement group_id="O2" value="0.105" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Angiogenesis Chemokine Concentration at Day 28</title>
        <description>Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Induced Gingivitis</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.&#xD;
Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.</description>
          </group>
          <group group_id="O2">
            <title>Oral Hygiene Maintenance</title>
            <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.&#xD;
Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Angiogenesis Chemokine Concentration at Day 28</title>
          <description>Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.</description>
          <units>picograms/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137825.56" spread="339893.64"/>
                    <measurement group_id="O2" value="164411.80" spread="408590.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>Participants were questioned at each visit about adverse events since the previous visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>Plaque Induced Gingivitis</title>
          <description>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.</description>
        </group>
        <group group_id="E2">
          <title>Oral Hygiene Maintenance</title>
          <description>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.</description>
        </group>
        <group group_id="E3">
          <title>Hygiene Phase</title>
          <description>Adverse Events that occurred during the Hygiene Phase of 2 weeks (the period between enrollment and the start of the Gingivitis Induction Phase of 2 weeks).</description>
        </group>
        <group group_id="E4">
          <title>Systemic Adverse Events</title>
          <description>Adverse Events that occurred during the Gingivitis Induction Phase of 2 weeks and the Resolution Phase 2 weeks but are not specifically attributable to either the Plaque Induced Gingivitis intervention or the Oral Hygiene Maintenance intervention as the two interventions occurred simultaneously in each participant.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abraded palatal tissue left posterior</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>rhinorrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ulcerated interdental papilla #14/15</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>bruised achilles tendon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>tender maxillary left posterior buccal gingiva</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>menstrual cramps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </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>Dr. Diane Daubert</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-685-3766</phone>
      <email>ddaubert@uw.edu</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/NCT03750955
org study id: SITE00000993
nct id: NCT03750955
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Using an experimental, non-invasive intra-oral imaging device, this study evaluates the
      effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two
      weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated
      as oral hygiene is resumed and the gingival tissue returns to health.
The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis
      induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.

      The intervention will consist of cessation of oral hygiene versus an active control of oral
      hygiene with a fluoridated toothpaste. This study is a modification of classical experimental
      gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant
      to the intervention, while the other sextant will serve as control in a split-mouth design of
      localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model
      (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral
      environment by leading to reversible inflammation of the gingival tissues. The purpose of
      this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an
      innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Split-mouth
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
time frame: Baseline to Day 14
description: The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
measure: Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
time frame: Day 14 to Day 28
description: The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
measure: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
time frame: Baseline to Day 14
description: The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
measure: Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
time frame: Day 14 to Day 28
description: The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
measure: Change From Baseline Angiogenesis Chemokine Concentration at Day 28
time frame: Baseline to Day 28
description: Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.
arm group label: Plaque induced gingivitis
arm group type: Experimental
description: Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.
arm group label: Oral hygiene maintenance
arm group type: Active Comparator
description: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.
intervention type: Device
intervention name: Plaque induced gingivitis
description: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.
arm group label: Plaque induced gingivitis
other name: Cessation of oral hygiene
intervention type: Device
intervention name: Oral hygiene maintenance
description: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
arm group label: Oral hygiene maintenance
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard P Darveau, MS, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Richard Darveau
investigator title: Professor, School of Dentistry
mesh term: Gingivitis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 