<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/NCT03762915</url>
  </required_header>
  <id_info>
    <org_study_id>DENT-2018-27312</org_study_id>
    <nct_id>NCT03762915</nct_id>
  </id_info>
  <brief_title>Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg</brief_title>
  <official_title>Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bausch Health Companies, INC.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to investigate the qualitative and quantitative effects of&#xD;
      scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on&#xD;
      periodontal pathogens and overall bacterial load.&#xD;
&#xD;
      A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with&#xD;
      minocycline HCl microspheres, 1 mg) group is planned.&#xD;
&#xD;
      Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and&#xD;
      test groups over a six month period.&#xD;
&#xD;
      Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with&#xD;
      minocycline HCl microspheres, 1 mg) group is planned.&#xD;
&#xD;
      The intervention of minocycline HCl microspheres, 1 mg will be administered in the&#xD;
      experimental group at baseline and the three month periodontal maintenance visit. Saliva&#xD;
      samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6&#xD;
      month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed&#xD;
      for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed&#xD;
      for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and&#xD;
      TNF-α.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Pathogenic Burden</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>Scale 0-100</description>
  </primary_outcome>
  <other_outcome>
    <measure>GCF markers</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>Change in picograms per mililitre (pg/ML)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Markers</measure>
    <time_frame>baseline, 1, 3, and 6 months</time_frame>
    <description>Change in picograms per mililitre (pg/ML) to known reference range</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>SRP</condition>
  <condition>Minocycline HCl Microspheres</condition>
  <condition>Biomarkers</condition>
  <arm_group>
    <arm_group_label>SRP with minocycline HCl microspheres</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRP without minocycline HCl microspheres</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not have minocycline HCl microspheres, 1 mg administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>minocycline HCl microspheres</intervention_name>
    <description>Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.</description>
    <arm_group_label>SRP with minocycline HCl microspheres</arm_group_label>
    <other_name>Arestin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  At least 21 years of age&#xD;
&#xD;
          -  ADA Class III-IV Chronic Periodontitis&#xD;
&#xD;
          -  Scaling and Root Planing (SRP) or localized SRP&#xD;
&#xD;
          -  A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to comply with study protocol&#xD;
&#xD;
          -  Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the&#xD;
             last 6 months&#xD;
&#xD;
          -  Cigarette use within the last year&#xD;
&#xD;
          -  ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six&#xD;
             weeks.&#xD;
&#xD;
          -  Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)&#xD;
&#xD;
          -  Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular&#xD;
             disease (ASVD) including coronary heart disease, cerebrovascular disease, and&#xD;
             peripheral artery disease, myocardial infarction, stroke, stable or unstable angina,&#xD;
             transient ischemic attack, or coronary or other arterial revascularization&#xD;
&#xD;
          -  Have any uncontrolled medical condition or immunocompromised that may impact the study&#xD;
             (uncontrolled diabetes HbA1c &gt; 7, HIV, etc.)&#xD;
&#xD;
          -  Tetracycline allergy&#xD;
&#xD;
          -  Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists,&#xD;
             cyclosporin, warfarin, or NSAIDS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Arnett</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 31, 2023</submitted>
    <returned>April 21, 2023</returned>
    <submitted>May 8, 2023</submitted>
    <returned>June 2, 2023</returned>
    <submitted>June 9, 2023</submitted>
    <returned>June 28, 2023</returned>
    <submitted>July 10, 2023</submitted>
    <returned>July 28, 2023</returned>
    <submitted>August 2, 2023</submitted>
    <returned>August 22, 2023</returned>
    <submitted>August 23, 2023</submitted>
    <returned>September 11, 2023</returned>
  </pending_results>
  <!-- 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/NCT03762915
org study id: DENT-2018-27312
nct id: NCT03762915
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary goal of this study is to investigate the qualitative and quantitative effects of
      scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on
      periodontal pathogens and overall bacterial load.

      A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with
      minocycline HCl microspheres, 1 mg) group is planned.

      Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and
      test groups over a six month period.

      Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.
A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with
      minocycline HCl microspheres, 1 mg) group is planned.

      The intervention of minocycline HCl microspheres, 1 mg will be administered in the
      experimental group at baseline and the three month periodontal maintenance visit. Saliva
      samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6
      month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed
      for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed
      for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and
      TNF-α.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Pathogenic Burden
time frame: baseline, 1, 3, and 6 months
description: Scale 0-100
measure: GCF markers
time frame: baseline, 1, 3, and 6 months
description: Change in picograms per mililitre (pg/ML)
measure: Serum Markers
time frame: baseline, 1, 3, and 6 months
description: Change in picograms per mililitre (pg/ML) to known reference range
arm group label: SRP with minocycline HCl microspheres
arm group type: Experimental
description: The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.
arm group label: SRP without minocycline HCl microspheres
arm group type: No Intervention
description: The control group will not have minocycline HCl microspheres, 1 mg administered.
intervention type: Drug
intervention name: minocycline HCl microspheres
description: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.
arm group label: SRP with minocycline HCl microspheres
other name: Arestin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michelle Arnett
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Minocycline
sharing ipd: Undecided
submitted: March 31, 2023
returned: April 21, 2023
submitted: May 8, 2023
returned: June 2, 2023
submitted: June 9, 2023
returned: June 28, 2023
submitted: July 10, 2023
returned: July 28, 2023
submitted: August 2, 2023
returned: August 22, 2023
submitted: August 23, 2023
returned: September 11, 2023