<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/NCT03786133</url>
  </required_header>
  <id_info>
    <org_study_id>periopathogensdiabetes</org_study_id>
    <nct_id>NCT03786133</nct_id>
  </id_info>
  <brief_title>Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients</brief_title>
  <official_title>The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a retrospective comparative evaluation of six main periodontal pathogens and&#xD;
      total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes&#xD;
      mellitus by polymerase chain reaction analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to compare prevalence and bacterial load of six main periodontal&#xD;
      pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus.&#xD;
      Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also&#xD;
      investigated.&#xD;
&#xD;
      The recruitment for the study sample was performed analysing the medical records of adult&#xD;
      patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were&#xD;
      subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes&#xD;
      mellitus at the time of the microbiological test.&#xD;
&#xD;
      For each subject, the following data have been collected: age, gender, smoking habits, type&#xD;
      of metabolic control of diabetes, duration of diabetes, number of missing teeth.&#xD;
&#xD;
      For each subject, four periodontal sites were studied. Probing pocket depth, sites with&#xD;
      bleeding on probing, sites with suppuration and microbiological data were evaluated.&#xD;
&#xD;
      An individual matching on the basis of severity and extension of periodontitis was performed&#xD;
      by pairing a diabetic patient with another non-diabetic one with the same degree of severity&#xD;
      and extension of the periodontal disease.&#xD;
&#xD;
      Microbiological data of subgingival biofilm were analysed and compared for the examined&#xD;
      pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella&#xD;
      intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia.&#xD;
&#xD;
      Differences in genotypes of Porphyromonas gingivalis and Aggregatibacter&#xD;
      actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2016</start_date>
  <completion_date type="Actual">November 16, 2016</completion_date>
  <primary_completion_date type="Actual">July 26, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial load of six main periodontal pathogens</measure>
    <time_frame>November 16th 2016</time_frame>
    <description>Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of six main periodontal pathogens</measure>
    <time_frame>November 16th 2016</time_frame>
    <description>Number of sites presenting a specific pathogen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative bacterial load of six main periodontal pathogens</measure>
    <time_frame>November 16th 2016</time_frame>
    <description>A mean percentage that derives from the comparison of the bacterial load to the total bacterial load</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total bacterial load</measure>
    <time_frame>November 16th 2016</time_frame>
    <description>A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans</measure>
    <time_frame>November 16th 2016</time_frame>
    <description>Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Periodontitis</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>type 2 diabetics</arm_group_label>
    <description>Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-diabetics</arm_group_label>
    <description>Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Analysis of microbiological tests</intervention_name>
    <description>Collection and comparison of microbiological data</description>
    <arm_group_label>non-diabetics</arm_group_label>
    <arm_group_label>type 2 diabetics</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The recruitment for the study sample was performed analysing the medical records of adult&#xD;
        patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were&#xD;
        subdivided in two balanced groups on the basis of the presence or absence of type 2&#xD;
        diabetes mellitus at the time of the microbiological test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of chronic periodontitis&#xD;
&#xD;
          -  diagnosis of type 2 diabetes mellitus (only in the test group)&#xD;
&#xD;
          -  the presence of at least 12 teeth (except for the third molar)&#xD;
&#xD;
          -  belonging to caucasian ethnic group&#xD;
&#xD;
          -  age greater than 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or lactating&#xD;
&#xD;
          -  history of systemic antibiotics within 3 months prior to the microbiological testing&#xD;
             or anti-inflammatory therapy in the month before the visit&#xD;
&#xD;
          -  if they were suffering from any other systemic disease except diabetes mellitus&#xD;
             (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV&#xD;
             infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or&#xD;
             pathologies that could potentially interfere with the periodontitis and/or with&#xD;
             diabetes)&#xD;
&#xD;
          -  mental disorders&#xD;
&#xD;
          -  if they had received periodontal treatment in the 6 months before the microbiological&#xD;
             test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Montevecchi, DDS</last_name>
    <role>Study Chair</role>
    <affiliation>University of Bologna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.</name>
      <address>
        <city>Bologna</city>
        <zip>40120</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Marco Montevecchi</investigator_full_name>
    <investigator_title>Aggregate Professor of Periodontology</investigator_title>
  </responsible_party>
  <keyword>Subgingival analysis</keyword>
  <keyword>Real-time PCR</keyword>
  <keyword>Comparative study</keyword>
  <keyword>Chronic Periodontitis</keyword>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available when the research will be published</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available when the research will be published</ipd_time_frame>
    <ipd_access_criteria>On request to the main investigator</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03786133
org study id: periopathogensdiabetes
nct id: NCT03786133
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a retrospective comparative evaluation of six main periodontal pathogens and
      total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes
      mellitus by polymerase chain reaction analysis.
The aim of this study was to compare prevalence and bacterial load of six main periodontal
      pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus.
      Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also
      investigated.

      The recruitment for the study sample was performed analysing the medical records of adult
      patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were
      subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes
      mellitus at the time of the microbiological test.

      For each subject, the following data have been collected: age, gender, smoking habits, type
      of metabolic control of diabetes, duration of diabetes, number of missing teeth.

      For each subject, four periodontal sites were studied. Probing pocket depth, sites with
      bleeding on probing, sites with suppuration and microbiological data were evaluated.

      An individual matching on the basis of severity and extension of periodontitis was performed
      by pairing a diabetic patient with another non-diabetic one with the same degree of severity
      and extension of the periodontal disease.

      Microbiological data of subgingival biofilm were analysed and compared for the examined
      pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella
      intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia.

      Differences in genotypes of Porphyromonas gingivalis and Aggregatibacter
      actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.
observational model: Case-Control
time perspective: Retrospective
measure: Bacterial load of six main periodontal pathogens
time frame: November 16th 2016
description: Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count
measure: Prevalence of six main periodontal pathogens
time frame: November 16th 2016
description: Number of sites presenting a specific pathogen
measure: Relative bacterial load of six main periodontal pathogens
time frame: November 16th 2016
description: A mean percentage that derives from the comparison of the bacterial load to the total bacterial load
measure: Total bacterial load
time frame: November 16th 2016
description: A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count
measure: Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans
time frame: November 16th 2016
description: Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared
arm group label: type 2 diabetics
description: Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus
arm group label: non-diabetics
description: Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus
intervention type: Diagnostic Test
intervention name: Analysis of microbiological tests
description: Collection and comparison of microbiological data
arm group label: non-diabetics
arm group label: type 2 diabetics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Montevecchi, DDS
role: Study Chair
affiliation: University of Bologna
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Marco Montevecchi
investigator title: Aggregate Professor of Periodontology
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: Data will be available when the research will be published
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available when the research will be published
ipd access criteria: On request to the main investigator