<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/NCT02187185</url>
  </required_header>
  <id_info>
    <org_study_id>09-0627</org_study_id>
    <nct_id>NCT02187185</nct_id>
  </id_info>
  <brief_title>Salivary Inflammatory Biomarkers: Predictors &amp; Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease</brief_title>
  <official_title>Studies of Salivary Inflammatory Biomarkers During Biofilm Overgrowth: Confirmation of Predictors and Comparative Effects of Sonicare/Elite-Flexcare in Various Stages of Periodontal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Oral Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study has 2 aims. One aim is to see if saliva testing can show if a person has&#xD;
      healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or&#xD;
      severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on&#xD;
      periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare&#xD;
      Flexcare tooth brushing following experimental induction of biofilm overgrowth in various&#xD;
      periodontal conditions.&#xD;
&#xD;
      This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the&#xD;
      utility of candidate inflammatory biomarkers within saliva to discriminate between health,&#xD;
      gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus&#xD;
      inactive states of periodontal disease to see if these basal levels can predict the clinical&#xD;
      response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the&#xD;
      claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as&#xD;
      compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and&#xD;
      P3].&#xD;
&#xD;
      The devices used in this study are subject only to Class I (general controls) and considered&#xD;
      exempt from the premarket notification procedures and not subject to section 510(k), 515, or&#xD;
      520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the&#xD;
      definition of an Applicable Clinical Trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Other</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.</measure>
    <time_frame>Four weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Inflammation</condition>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Sonicare Elite-Flexcare</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the Sonicare/Elite/Flexcare toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Toothbrush</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 2 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the manual toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sonicare/Elite-Flexcare Toothbrush</intervention_name>
    <description>Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles</description>
    <arm_group_label>Sonicare Elite-Flexcare</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Toothbrush</intervention_name>
    <description>traditional (non-mechanical) toothbrush with nylon bristles and plastic handle</description>
    <arm_group_label>Manual Toothbrush</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adult males or females between the ages of 18 and 75 years (inclusive).&#xD;
&#xD;
          2. able and willing to follow study procedures and instructions.&#xD;
&#xD;
          3. read, understood and signed an informed consent form.&#xD;
&#xD;
          4. present with at least 8 teeth in the functional dentition with a minimum of 3 adjacent&#xD;
             teeth with interproximal papilla in each posterior sextant that will have the stent.&#xD;
&#xD;
          5. be in good general health.&#xD;
&#xD;
          6. present with one of the following five categories to be considered for enrollment&#xD;
&#xD;
               -  BGI health (all PD&lt;3mm, BOP&lt;10%)&#xD;
&#xD;
               -  BGI-gingivitis (all PD≤3mm, BOP≥10%)&#xD;
&#xD;
               -  BGI-P1 (1+ site with PD&gt;3mm, BOP≤10%)&#xD;
&#xD;
               -  BGI-P2 (1+ site with PD&gt;3mm, BOP&gt;10% but BOP≤50%)&#xD;
&#xD;
               -  BGI-P3 (1+ site with PD&gt;3mm, BOP&gt;50%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. chronic disease with oral manifestations or active infectious diseases such as&#xD;
             hepatitis, HIV or tuberculosis.&#xD;
&#xD;
          2. gross oral pathology.&#xD;
&#xD;
          3. treatment with antibiotics for any medical or dental condition within 1 month prior to&#xD;
             the screening examination.&#xD;
&#xD;
          4. chronic treatment (i.e., two weeks or more) with any medication known to affect&#xD;
             periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants,&#xD;
             non-steroidal anti-inflammatory drugs, high dose aspirin such as &gt;100mg per day)&#xD;
             within one month of the screening examination.&#xD;
&#xD;
          5. ongoing medications initiated less than three months prior to enrollment (i.e.,&#xD;
             medications for chronic medical conditions must be initiated at least three months&#xD;
             prior to enrollment).&#xD;
&#xD;
          6. clinically significant organ disease including impaired renal function, and/or any&#xD;
             bleeding disorder.&#xD;
&#xD;
          7. severe unrestored caries, or any condition that is likely to require antibiotic&#xD;
             treatment during the study, including the need for prophylactic antibiotic.&#xD;
&#xD;
          8. use any tobacco products or who have used tobacco products within the previous six&#xD;
             months of the screening examination.&#xD;
&#xD;
          9. pregnant, or expect to become pregnant within the next three months and individuals&#xD;
             nursing.&#xD;
&#xD;
         10. dental appliances that will interfere with stent construction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Offenbacher, DDS PhD MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of North Carolina at Chapel Hill School of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill School of Dentistry</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory biomarkers</keyword>
  <keyword>Periodontitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187185
org study id: 09-0627
nct id: NCT02187185
lead sponsor: 
collaborator: 
has dmc: No
This research study has 2 aims. One aim is to see if saliva testing can show if a person has
      healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or
      severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on
      periodontitis.
Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare
      Flexcare tooth brushing following experimental induction of biofilm overgrowth in various
      periodontal conditions.

      This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the
      utility of candidate inflammatory biomarkers within saliva to discriminate between health,
      gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus
      inactive states of periodontal disease to see if these basal levels can predict the clinical
      response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the
      claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as
      compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and
      P3].

      The devices used in this study are subject only to Class I (general controls) and considered
      exempt from the premarket notification procedures and not subject to section 510(k), 515, or
      520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the
      definition of an Applicable Clinical Trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.
time frame: Four weeks
measure: Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).
time frame: 4 weeks
arm group label: Sonicare Elite-Flexcare
arm group type: Active Comparator
description: Arm 1 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the Sonicare/Elite/Flexcare toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution.
arm group label: Manual Toothbrush
arm group type: Active Comparator
description: Arm 2 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the manual toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution.
intervention type: Other
intervention name: Sonicare/Elite-Flexcare Toothbrush
description: Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles
arm group label: Sonicare Elite-Flexcare
intervention type: Other
intervention name: Manual Toothbrush
description: traditional (non-mechanical) toothbrush with nylon bristles and plastic handle
arm group label: Manual Toothbrush
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Offenbacher, DDS PhD MMSc
role: Principal Investigator
affiliation: The University of North Carolina at Chapel Hill School of Dentistry
facility: 
country: United States
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Inflammation