<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/NCT03279718</url>
  </required_header>
  <id_info>
    <org_study_id>Expertention</org_study_id>
    <nct_id>NCT03279718</nct_id>
  </id_info>
  <brief_title>Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD</brief_title>
  <acronym>Expertention</acronym>
  <official_title>Exploring Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current data are showing a potential link between inflammatory biomarkers in chronic&#xD;
      periodontitis and COPD. However the impact of periodontal treatment on systemic inflammation&#xD;
      as measured by biomarkers and time to occurrence of acute exacerbations (AECOPD) remains an&#xD;
      important but unresolved issue. This pilot study will provide information on effects of&#xD;
      periodontal treatment on systemic inflammation and the course of COPD including acute&#xD;
      exacerbation.&#xD;
&#xD;
      40 patients with chronic periodontitis and COPD will be included in this study. First&#xD;
      baseline information (age, gender, lifestyle, smoking history, medical history, medication,&#xD;
      frequency of exacerbation, dental treatments) are recorded. Then patient's health status is&#xD;
      assessed using the COPD Assessment Test (CAT) and a comprehensive lung function testing&#xD;
      (bodyplethysmograph) is conducted to assess lung functional severity of COPD. Blood samples&#xD;
      are taken for analysis of various inflammatory biomarkers and saliva and sputum samples are&#xD;
      collected for analysis of microbiome.&#xD;
&#xD;
      Afterwards experienced dentists will conduct oral health examination and record the&#xD;
      periodontal conditions of every patient. Samples of gingival crevicular fluid for determining&#xD;
      Matrix metallopeptidase 8 (MMP8), Interleukin 1 beta (IL-1beta) and Interleukin 6 (IL-69&#xD;
      levels and for microbiome analysis will be taken. After randomization to one of the two study&#xD;
      groups (intervention group: periodontal treatment / control group: no periodontal treatment)&#xD;
      all patients get comprehensive oral hygiene instructions, irrespective of their periodontal&#xD;
      status . Patients of the control group receive no further planned dental intervention. For&#xD;
      patients of the experimental group, who need periodontal treatment due to the presence of&#xD;
      periodontal pocket depth of ≥ 4 mm an appropriate care plan will be determined and supra- and&#xD;
      subgingival scaling and root planing will be performed.&#xD;
&#xD;
      During a 3, 6 and 12 months follow-up patient's current health condition will be assessed&#xD;
      using the CAT. Additionally lung function tests (bodyplethysmograph) will be performed and&#xD;
      clinical periodontal parameters are re-evaluated. To detect and assess COPD exacerbations in&#xD;
      this trial, patients will complete a daily diary during the whole follow-up period which will&#xD;
      be provided to the clinical researcher at each study visit. Furthermore the cough and sputum&#xD;
      assessment questionnaire (CASA-Q)) will be used at each telephone call and at each visit in&#xD;
      the pulmonary center. After 6 and 12 months blood, sputum, saliva and gingival crevicular&#xD;
      fluid will be taken additionally. To understand the microbial ecology mechanisms linking&#xD;
      periodontitis to COPD combined analysis of oral cavity microbiome (GCF) and lung microbiome&#xD;
      (sputum) will be conducted. The biomarkers high sensitive C-reactive Protein (hsCRP), MMP8,&#xD;
      IL-1beta und IL-6 will be determined in blood and in gingival crevicular fluid, respectively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment challenges due to COVID pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood serum inflammatory biomarker hsCRP</measure>
    <time_frame>after 6 months and after 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>COPD Exacerbation, Periodontal Health</condition>
  <arm_group>
    <arm_group_label>periodontal treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>only oral hygiene instruction, no treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal Treatment</intervention_name>
    <description>Scaling and root planing</description>
    <arm_group_label>periodontal treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        COPD functional class B to D (moderate to very severe) according to the Global Initiative&#xD;
        For Chronic Obstructive Lung Disease (GOLD)&#xD;
&#xD;
          -  age ≥ 40 and ≤ 80 years&#xD;
&#xD;
          -  at least 10 natural teeth&#xD;
&#xD;
          -  COPD-associated hsCRP elevation (after exclusion of infection) with hsCRP &gt; 3mg/l&#xD;
&#xD;
          -  presence of chronic periodontitis&#xD;
&#xD;
          -  at least 1 exacerbation leading to treatment with systemic glucocorticoids or&#xD;
             antibiotics or hospitalization within the last 12 months&#xD;
&#xD;
          -  non-smoker or ex-smoker for at least the last 6 months&#xD;
&#xD;
          -  ability to understand the character and individual consequences of participation in&#xD;
             this trial and to give written informed consent&#xD;
&#xD;
          -  provision of a written informed consent to participation in the trial prior to trial&#xD;
             start and any trial-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any subgingival root-planing or any kind of periodontal surgery within the last 6&#xD;
             months (professional tooth cleaning is allowed)&#xD;
&#xD;
          -  any antibiotics and/or systemic corticosteroid medication in the last 4 weeks before&#xD;
             inclusion&#xD;
&#xD;
          -  any antibiotics needed as prophylaxis or as an adjunct to periodontal treatment&#xD;
&#xD;
          -  diagnostical bronchoscopy within the last 8 weeks&#xD;
&#xD;
          -  any kind of bronchoscopy and lung surgery (volume reduction, transplantation,&#xD;
             pneumonectomy) within the last 6 months&#xD;
&#xD;
          -  concurrent participation in any interventional clinical trial (observational trials&#xD;
             are allowed)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Kreuter, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thoraxklinik, University Hospital Heidelberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic for Operative Dentistry, University Hospital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for Dental and Oral Medicine, Dept. of Periodontology, Philipps-University of Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35039</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Internal Medicine (focus Pneumology) , University Hospital Gießen und Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Michael Kreuter</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03279718
org study id: Expertention
nct id: NCT03279718
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Current data are showing a potential link between inflammatory biomarkers in chronic
      periodontitis and COPD. However the impact of periodontal treatment on systemic inflammation
      as measured by biomarkers and time to occurrence of acute exacerbations (AECOPD) remains an
      important but unresolved issue. This pilot study will provide information on effects of
      periodontal treatment on systemic inflammation and the course of COPD including acute
      exacerbation.

      40 patients with chronic periodontitis and COPD will be included in this study. First
      baseline information (age, gender, lifestyle, smoking history, medical history, medication,
      frequency of exacerbation, dental treatments) are recorded. Then patient's health status is
      assessed using the COPD Assessment Test (CAT) and a comprehensive lung function testing
      (bodyplethysmograph) is conducted to assess lung functional severity of COPD. Blood samples
      are taken for analysis of various inflammatory biomarkers and saliva and sputum samples are
      collected for analysis of microbiome.

      Afterwards experienced dentists will conduct oral health examination and record the
      periodontal conditions of every patient. Samples of gingival crevicular fluid for determining
      Matrix metallopeptidase 8 (MMP8), Interleukin 1 beta (IL-1beta) and Interleukin 6 (IL-69
      levels and for microbiome analysis will be taken. After randomization to one of the two study
      groups (intervention group: periodontal treatment / control group: no periodontal treatment)
      all patients get comprehensive oral hygiene instructions, irrespective of their periodontal
      status . Patients of the control group receive no further planned dental intervention. For
      patients of the experimental group, who need periodontal treatment due to the presence of
      periodontal pocket depth of ≥ 4 mm an appropriate care plan will be determined and supra- and
      subgingival scaling and root planing will be performed.

      During a 3, 6 and 12 months follow-up patient's current health condition will be assessed
      using the CAT. Additionally lung function tests (bodyplethysmograph) will be performed and
      clinical periodontal parameters are re-evaluated. To detect and assess COPD exacerbations in
      this trial, patients will complete a daily diary during the whole follow-up period which will
      be provided to the clinical researcher at each study visit. Furthermore the cough and sputum
      assessment questionnaire (CASA-Q)) will be used at each telephone call and at each visit in
      the pulmonary center. After 6 and 12 months blood, sputum, saliva and gingival crevicular
      fluid will be taken additionally. To understand the microbial ecology mechanisms linking
      periodontitis to COPD combined analysis of oral cavity microbiome (GCF) and lung microbiome
      (sputum) will be conducted. The biomarkers high sensitive C-reactive Protein (hsCRP), MMP8,
      IL-1beta und IL-6 will be determined in blood and in gingival crevicular fluid, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in blood serum inflammatory biomarker hsCRP
time frame: after 6 months and after 12 months
arm group label: periodontal treatment
arm group type: Experimental
arm group label: only oral hygiene instruction, no treatment
arm group type: No Intervention
intervention type: Procedure
intervention name: Periodontal Treatment
description: Scaling and root planing
arm group label: periodontal treatment
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael Kreuter, Prof.
role: Principal Investigator
affiliation: Thoraxklinik, University Hospital Heidelberg
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Michael Kreuter
investigator title: Prof. Dr. med.
mesh term: Inflammation