<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/NCT04450810</url>
  </required_header>
  <id_info>
    <org_study_id>23-18</org_study_id>
    <nct_id>NCT04450810</nct_id>
  </id_info>
  <brief_title>Role of NLRP3 in Periodontitis and Diabetes</brief_title>
  <official_title>Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Messina</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>
      NLRP3 plays a key role in endothelial function and may be a link for the known interaction of&#xD;
      periodontitis and diabetes. The investigators compared the impact of gingival health,&#xD;
      periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum&#xD;
      NLRP3levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to evaluate a possible association between NLRP3 and gingival&#xD;
      health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum&#xD;
      NLRP3 levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 18, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>1-year</time_frame>
    <description>evaluation of changes in clinical attachment level</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">133</enrollment>
  <condition>Metabolic Disease</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Evaluation of serum and salivary NLRP3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periodontitis</arm_group_label>
    <description>Evaluation of serum and salivary NLRP3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes</arm_group_label>
    <description>Evaluation of serum and salivary NLRP3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periodontitis + diabetes</arm_group_label>
    <description>Evaluation of serum and salivary NLRP3</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of serum and salivary NLRP3 levels</intervention_name>
    <description>Evaluation of serum and salivary NLRP3 levels</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Diabetes</arm_group_label>
    <arm_group_label>Periodontitis</arm_group_label>
    <arm_group_label>Periodontitis + diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of&#xD;
        periodontitis + diabetes (n=34)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of at least 15 teeth&#xD;
&#xD;
          -  CP with a minimum of 40% of sites with a clinical attachment level (CAL)&#xD;
&#xD;
             ≥2mm and probing depth (PD) ≥4mm;&#xD;
&#xD;
          -  Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital&#xD;
             periapical radiographs&#xD;
&#xD;
          -  Presence of ≥40% sites with bleeding on probing (BOP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intake of contraceptives&#xD;
&#xD;
          -  Intake of immunosuppressive or anti-inflammatory drugs throughout the last three&#xD;
             months prior to the study&#xD;
&#xD;
          -  Status of pregnancy or lactation&#xD;
&#xD;
          -  Previous history of excessive drinking&#xD;
&#xD;
          -  Allergy to local anaesthetic&#xD;
&#xD;
          -  Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin,&#xD;
             Nifedipine, Cyclosporin A or similar drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giovanni Matarese</last_name>
    <role>Study Chair</role>
    <affiliation>University of Messina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Messina</name>
      <address>
        <city>Messina</city>
        <zip>98100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 23, 2021</last_update_submitted>
  <last_update_submitted_qc>January 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Gaetano Isola, DDS, PhD</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all collected IPD, all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>10 tears</ipd_time_frame>
    <ipd_access_criteria>pubmed</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/NCT04450810
org study id: 23-18
nct id: NCT04450810
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
NLRP3 plays a key role in endothelial function and may be a link for the known interaction of
      periodontitis and diabetes. The investigators compared the impact of gingival health,
      periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum
      NLRP3levels.
The aim of this study was to evaluate a possible association between NLRP3 and gingival
      health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum
      NLRP3 levels.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Clinical attachment level
time frame: 1-year
description: evaluation of changes in clinical attachment level
arm group label: Control
description: Evaluation of serum and salivary NLRP3
arm group label: Periodontitis
description: Evaluation of serum and salivary NLRP3
arm group label: Diabetes
description: Evaluation of serum and salivary NLRP3
arm group label: Periodontitis + diabetes
description: Evaluation of serum and salivary NLRP3
intervention type: Other
intervention name: Observation of serum and salivary NLRP3 levels
description: Evaluation of serum and salivary NLRP3 levels
arm group label: Control
arm group label: Diabetes
arm group label: Periodontitis
arm group label: Periodontitis + diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Giovanni Matarese
role: Study Chair
affiliation: University of Messina
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Gaetano Isola, DDS, PhD
investigator title: Researcher
mesh term: Periodontitis
mesh term: Periodontal Diseases
mesh term: Metabolic Diseases
sharing ipd: Yes
ipd description: all collected IPD, all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: 10 tears
ipd access criteria: pubmed