<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/NCT04417322</url>
  </required_header>
  <id_info>
    <org_study_id>16-18-01</org_study_id>
    <nct_id>NCT04417322</nct_id>
  </id_info>
  <brief_title>Serum A.Actinomycetemcomitans Antibodies and Periodontitis</brief_title>
  <official_title>Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis</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>
      The aim of this study was to analyze the association between serum A.actinomycetemcomitans&#xD;
      antibodies in patients with periodontitis. Furthermore, the objective was to determine if the&#xD;
      periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present&#xD;
      study. Enrolled patients were examined and characterized for clinical and blood samples&#xD;
      analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked&#xD;
      immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra&#xD;
      Test were applied in order to assess the interdependence between serum IgG&#xD;
      A.actinomycetemcomitans antibodies and clinical periodontal parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2016</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 2, 2020</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>2</number_of_groups>
  <enrollment type="Actual">221</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periodontitis</arm_group_label>
    <description>Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation of serum A.actinomycetemcomitans levels</intervention_name>
    <description>Analysis of serum A.actinomycetemcomitans levels</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Periodontitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present&#xD;
        study. Enrolled patients were examined and characterized for clinical and blood samples&#xD;
        analysis, andA.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked&#xD;
        immunosorbent assay (ELISA) units (EU).&#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>34 Years</minimum_age>
    <maximum_age>72 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>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>
  </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>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>1-year</ipd_time_frame>
    <ipd_access_criteria>Official website</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/NCT04417322
org study id: 16-18-01
nct id: NCT04417322
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to analyze the association between serum A.actinomycetemcomitans
      antibodies in patients with periodontitis. Furthermore, the objective was to determine if the
      periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels
53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present
      study. Enrolled patients were examined and characterized for clinical and blood samples
      analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked
      immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra
      Test were applied in order to assess the interdependence between serum IgG
      A.actinomycetemcomitans antibodies and clinical periodontal parameters.
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: Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
arm group label: Periodontitis
description: Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
intervention type: Other
intervention name: observation of serum A.actinomycetemcomitans levels
description: Analysis of serum A.actinomycetemcomitans levels
arm group label: Control
arm group label: Periodontitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 34 Years
maximum age: 72 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
sharing ipd: Yes
ipd description: all collected IPD, all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 1-year
ipd access criteria: Official website