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/NCT05995158</url>
    </required_header>
    <id_info>
      <org_study_id>127-10-18</org_study_id>
      <nct_id>NCT05995158</nct_id>
    </id_info>
    <brief_title>Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study</brief_title>
    <official_title>Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Abdulaziz University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King Abdulaziz University</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>
        Periodontitis is a widely prevalent disease worldwide that has serious public health&#xD;
        consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively&#xD;
        affects chewing causing functional disability; and esthetics causing social impairment.&#xD;
        Consequently, periodontitis may end up causing marked impairment of the quality of life of&#xD;
        the affected patients, impairment of general health and increasing the dental care costs&#xD;
        significantly.&#xD;
  &#xD;
        Dysbiotic changes in the oral microbiome arise after some microbial species are enriched by&#xD;
        primary products resulting from tissue breakdown due to gingivitis. It then triggers the host&#xD;
        cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical&#xD;
        migration of the junctional epithelium and apical spread of bacterial biofilm.&#xD;
  &#xD;
        However, the dysbiotic changes may be more likely to occur in some patients rather than&#xD;
        others due to certain risk factors including smoking and immuneinflammatory responses. Thus,&#xD;
        the severity of periodontal disease in these patients would be higher. Tobacco smoking is no&#xD;
        longer considered to be a habit, but a dependence to nicotine and a chronic relapsing medical&#xD;
        disorder. Among its detrimental effects on general health, tobacco smoking increases the risk&#xD;
        of periodontitis by 2 to 5 folds. This takes place by increasing the dysbiotic changes in the&#xD;
        oral microbiome and so, increasing the severity and extent of the periodontal disease at a&#xD;
        younger age. Therefore, smoking has been considered as a modifying factor of periodontitis&#xD;
        that should be considered upon periodontitis case grading definition.&#xD;
  &#xD;
        Therefore, this research aims to identify the difference in dysbiosis between the three&#xD;
        categories of periodontitis, trying to understand the cause of the resistance of each&#xD;
        category to treatment compared to the milder category.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>oral microbiome composition by NGS sequencing using next generation sequencer</measure>
      <time_frame>1 month</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Probing depth (mm) by periodontal probe</measure>
      <time_frame>1 month</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing</measure>
      <time_frame>1 month</time_frame>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">60</enrollment>
    <condition>Condition, Chronic Periodontitis</condition>
    <arm_group>
      <arm_group_label>Smokers ≥ 10 cigarettes/day</arm_group_label>
      <description>metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Smokers &lt; 10 cigarettes/day</arm_group_label>
      <description>metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-smokers</arm_group_label>
      <description>metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Metagenomic testing of the subgingival plaque samples</intervention_name>
      <description>sampling, extraction and sequencing of the oral microbiome in the samples</description>
      <arm_group_label>Smokers &lt; 10 cigarettes/day</arm_group_label>
      <arm_group_label>Smokers ≥ 10 cigarettes/day</arm_group_label>
      <arm_group_label>non-smokers</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        samples of the subgingival plaque&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          adult patients clinically diagnosed to have chronic periodontitis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients 18 years or older.&#xD;
  &#xD;
            -  Patients with periodontitis.&#xD;
  &#xD;
            -  Probing pocket depth ≥ 4 mm.&#xD;
  &#xD;
            -  Teeth with CAL≥ 3 mm at ≥2 non-adjacent teeth.&#xD;
  &#xD;
            -  Clinical indication and/or patient request for treatment of the periodontal condition.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any systemic diseases.&#xD;
  &#xD;
            -  Pregnant females.&#xD;
  &#xD;
            -  Patients who took any antibiotic in the past month.&#xD;
  &#xD;
            -  Handicapped and mentally retarded patients.&#xD;
  &#xD;
            -  Patients undergoing radiotherapy.&#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>Jazia A Alblowi, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>King Abdulaziz University Faculty of Dentistry</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>King Abdulaziz University</name>
        <address>
          <city>Jeddah</city>
          <zip>21589</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
      <investigator_full_name>Jazia Alblowi</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <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>Chronic Disease</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/NCT05995158
  org study id: 127-10-18
  nct id: NCT05995158
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Periodontitis is a widely prevalent disease worldwide that has serious public health
        consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively
        affects chewing causing functional disability; and esthetics causing social impairment.
        Consequently, periodontitis may end up causing marked impairment of the quality of life of
        the affected patients, impairment of general health and increasing the dental care costs
        significantly.
  
        Dysbiotic changes in the oral microbiome arise after some microbial species are enriched by
        primary products resulting from tissue breakdown due to gingivitis. It then triggers the host
        cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical
        migration of the junctional epithelium and apical spread of bacterial biofilm.
  
        However, the dysbiotic changes may be more likely to occur in some patients rather than
        others due to certain risk factors including smoking and immuneinflammatory responses. Thus,
        the severity of periodontal disease in these patients would be higher. Tobacco smoking is no
        longer considered to be a habit, but a dependence to nicotine and a chronic relapsing medical
        disorder. Among its detrimental effects on general health, tobacco smoking increases the risk
        of periodontitis by 2 to 5 folds. This takes place by increasing the dysbiotic changes in the
        oral microbiome and so, increasing the severity and extent of the periodontal disease at a
        younger age. Therefore, smoking has been considered as a modifying factor of periodontitis
        that should be considered upon periodontitis case grading definition.
  
        Therefore, this research aims to identify the difference in dysbiosis between the three
        categories of periodontitis, trying to understand the cause of the resistance of each
        category to treatment compared to the milder category.
  observational model: Case-Control
  time perspective: Prospective
  measure: oral microbiome composition by NGS sequencing using next generation sequencer
  time frame: 1 month
  measure: Probing depth (mm) by periodontal probe
  time frame: 1 month
  measure: Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing
  time frame: 1 month
  arm group label: Smokers ≥ 10 cigarettes/day
  description: metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)
  arm group label: Smokers < 10 cigarettes/day
  description: metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)
  arm group label: non-smokers
  description: metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)
  intervention type: Procedure
  intervention name: Metagenomic testing of the subgingival plaque samples
  description: sampling, extraction and sequencing of the oral microbiome in the samples
  arm group label: Smokers < 10 cigarettes/day
  arm group label: Smokers ≥ 10 cigarettes/day
  arm group label: non-smokers
  samples of the subgingival plaque
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jazia A Alblowi, PhD
  role: Principal Investigator
  affiliation: King Abdulaziz University Faculty of Dentistry
  facility: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: King Abdulaziz University
  investigator full name: Jazia Alblowi
  investigator title: Associate Professor
  mesh term: Periodontitis
  mesh term: Chronic Periodontitis
  mesh term: Chronic Disease
  sharing ipd: No