xml: <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/NCT05968742</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016247</org_study_id>
      <secondary_id>R01DE031470</secondary_id>
      <nct_id>NCT05968742</nct_id>
    </id_info>
    <brief_title>Variation in Gingival Inflammatory Responses</brief_title>
    <official_title>Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
        <agency_class>NIH</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>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded&#xD;
        study is to identify molecular mechanisms underlying observed variations in human responses&#xD;
        to natural accumulation and maturation of dental plaque.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will employ the split-mouth Experimental Gingivitis model where healthy study&#xD;
        participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for&#xD;
        a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental&#xD;
        Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on&#xD;
        the test teeth will result in the natural accumulation and maturation of dental plaque (a&#xD;
        bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By&#xD;
        investigating the onset of microbially induced inflammation directly in humans using this&#xD;
        highly utilized and well-described experimental gingivitis model, the research community are&#xD;
        able to better understand the host-microbial interactions during the initiation, induction of&#xD;
        host response, and resolution of mucosal inflammation at the molecular level. The&#xD;
        investigators central hypothesis is based on our previous experimental gingivitis studies&#xD;
        conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival&#xD;
        Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical&#xD;
        inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both&#xD;
        microbial factors regulating the subgingival plaque growth and maturation rate as well as&#xD;
        host factors regulating the human gingival inflammatory mediator levels and type.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Identification of clinical responder types</measure>
      <time_frame>Day 0 to Day 21</time_frame>
      <description>Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in relative abundance of bacteria</measure>
      <time_frame>Day 0 to Day 21</time_frame>
      <description>The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Gingivitis</condition>
    <arm_group>
      <arm_group_label>Healthy Volunteers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days.&#xD;
  The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Abstinence of oral hygiene on select teeth</intervention_name>
      <description>Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days</description>
      <arm_group_label>Healthy Volunteers</arm_group_label>
      <other_name>Split Mouth Experimental Gingivitis</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide signed and dated informed consent form&#xD;
  &#xD;
            -  Willing to comply with all study procedures and be available for the duration of the&#xD;
               study&#xD;
  &#xD;
            -  Male or female, aged 18-35 years&#xD;
  &#xD;
            -  Good general health, ASA I (healthy with no systemic conditions)&#xD;
  &#xD;
            -  No clinical signs of gingival inflammation at &gt; 90% of sites observed (whole mouth) (&lt;&#xD;
               10% of sites with GI of &lt; 2 and no sites with a score of 3; &lt; 10% sites with BOP +).&#xD;
  &#xD;
            -  Probing depth (PD) ≤ 3.0 mm (Whole Mouth)&#xD;
  &#xD;
            -  Attachment loss (AL) = 0 mm (Whole Mouth)&#xD;
  &#xD;
            -  Gingival health at Visit 2 (Day 0) for study sites (Test/Control teeth): Average&#xD;
               Gingival Index (GI) ≤ 0.1 with no site having a score of 3 and bleeding on probing&#xD;
               (BOP)(-)&#xD;
  &#xD;
            -  Never smokers&#xD;
  &#xD;
            -  The ability to understand and communicate with the examiner.&#xD;
  &#xD;
            -  Willing and able to comply with study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medical condition which requires premedication prior to dental treatments/visits&#xD;
  &#xD;
            -  Subjects unable or unwilling to sign the informed consent form&#xD;
  &#xD;
            -  History of periodontal disease&#xD;
  &#xD;
            -  History of systemic inflammatory or immune conditions, Diabetes&#xD;
  &#xD;
            -  Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment&#xD;
  &#xD;
            -  Self-reported pregnancy, planned pregnancy during the planned study commitment, and/or&#xD;
               breastfeeding at the time of screening.&#xD;
  &#xD;
            -  Concurrent orthodontic treatment&#xD;
  &#xD;
            -  Untreated carious lesions and/or inadequate restorations on maxillary posterior 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 dentures&#xD;
               affecting the maxillary posterior teeth&#xD;
  &#xD;
            -  Missing tooth/teeth within the study sites test and control&#xD;
  &#xD;
            -  History of allergy to common dentifrice ingredients&#xD;
  &#xD;
            -  Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug&#xD;
               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>Jeffrey S McLean, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marilynn Rothen, RDH, MS</last_name>
      <phone>206-685-8132</phone>
      <email>rothen@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jeffrey S McLean, PhD</last_name>
        <phone>206-616-1808</phone>
        <email>jsmclean@uw.edu</email>
      </contact>
      <contact_backup>
        <last_name>Marilyn Rothen</last_name>
        <phone>(206) 685-8132</phone>
        <email>rothen@uw.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.</citation>
      <PMID>34193520</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Jeffrey McLean</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Experimental Gingivitis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968742
  org study id: STUDY00016247
  secondary id: R01DE031470
  nct id: NCT05968742
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded
        study is to identify molecular mechanisms underlying observed variations in human responses
        to natural accumulation and maturation of dental plaque.
  This study will employ the split-mouth Experimental Gingivitis model where healthy study
        participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for
        a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental
        Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on
        the test teeth will result in the natural accumulation and maturation of dental plaque (a
        bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By
        investigating the onset of microbially induced inflammation directly in humans using this
        highly utilized and well-described experimental gingivitis model, the research community are
        able to better understand the host-microbial interactions during the initiation, induction of
        host response, and resolution of mucosal inflammation at the molecular level. The
        investigators central hypothesis is based on our previous experimental gingivitis studies
        conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival
        Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical
        inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both
        microbial factors regulating the subgingival plaque growth and maturation rate as well as
        host factors regulating the human gingival inflammatory mediator levels and type.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Identification of clinical responder types
  time frame: Day 0 to Day 21
  description: Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.
  measure: Change in relative abundance of bacteria
  time frame: Day 0 to Day 21
  description: The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.
  arm group label: Healthy Volunteers
  arm group type: Experimental
  description: Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days.
  The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).
  intervention type: Behavioral
  intervention name: Abstinence of oral hygiene on select teeth
  description: Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days
  arm group label: Healthy Volunteers
  other name: Split Mouth Experimental Gingivitis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeffrey S McLean, PhD
  role: Principal Investigator
  affiliation: University of Washington
  last name: Marilynn Rothen, RDH, MS
  phone: 206-685-8132
  email: rothen@uw.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  citation: Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.
  PMID: 34193520
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Jeffrey McLean
  investigator title: Associate Professor
  mesh term: Gingivitis
  sharing ipd: No