<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/NCT03262402</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 50004415.1.0000.5419</org_study_id>
    <nct_id>NCT03262402</nct_id>
  </id_info>
  <brief_title>Effects of Periodontal Treatment on HIV-infected Patients</brief_title>
  <official_title>Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      Periodontal diseases, such as chronic periodontitis (CP), frequently occur in&#xD;
      immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by&#xD;
      the HIV infection can justify the high frequency and the difficult in controlling the CP in&#xD;
      this group of patients, raising the possibility of additional factors associated to the&#xD;
      development of CP in HIV patients. The aim of this study is to determine factors that can be&#xD;
      involved in the CP pathogenesis in HIV patients, including Candida spp presence, and&#xD;
      biomarkers involved on the inflammatory response against the microorganisms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV&#xD;
      patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid&#xD;
      concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis&#xD;
      factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In&#xD;
      order to minimize the influence of the immunosuppressive condition, patients have to present&#xD;
      CD4 T lymphocytes &lt; 200cel/mm3 blood count, non-detectable viral load and the same protocol&#xD;
      of antiretroviral therapy. Additionally, investigators intend to determine the&#xD;
      immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This&#xD;
      study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão&#xD;
      Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed&#xD;
      consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2017</start_date>
  <completion_date type="Actual">April 8, 2019</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in clinical signs of chronic periodontitis.</measure>
    <time_frame>Baseline, 30 days and 90 days.</time_frame>
    <description>Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Candida spp carriage.</measure>
    <time_frame>Baseline, 30 days and 90 days.</time_frame>
    <description>Number of Candida spp colonies on culture plates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salivary biomarkers</measure>
    <time_frame>Baseline, 30 days and 90 days.</time_frame>
    <description>Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bacterial microbiota</measure>
    <time_frame>Baseline, 30 days and 90 days.</time_frame>
    <description>Pyrosequencing characterization of the bacterial microbiota</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>HIV-infected group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-HIV infected group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Basic periodontal treatment</intervention_name>
    <description>Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.</description>
    <arm_group_label>HIV-infected group</arm_group_label>
    <arm_group_label>Non-HIV infected group</arm_group_label>
    <other_name>Non-surgical periodontal treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General for both groups/arms: Patients with at least 15 teeth; with chronic&#xD;
             periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical&#xD;
             attachment loss &gt;4mm); no use of antibiotics for the 6 months previous to study&#xD;
             enrolment.&#xD;
&#xD;
          -  For HIV-infected group: CD4 T lymphocytes &lt; 200 cel/mm3, stable HAART for the 6 months&#xD;
             previous to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General for both groups/arms: periodontal treatment and use of antibiotics for the 6&#xD;
             months previous to study enrollment; smoking; complex systemic conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Carolina F Motta, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Dentistry of Ribeirão Preto, University of São Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14040-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.</citation>
    <PMID>28591257</PMID>
  </reference>
  <reference>
    <citation>Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.</citation>
    <PMID>24720483</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ana Carolina Fragoso Motta, DDS, PhD</investigator_full_name>
    <investigator_title>Professor of Oral Diagnosis</investigator_title>
  </responsible_party>
  <keyword>Chronic periodontitis</keyword>
  <keyword>Candida spp</keyword>
  <keyword>Histatin-5</keyword>
  <keyword>Lactoferrin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data of all primary and secondary outcomes will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available within 3 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access criteria will be reviewed by the an external independent review panel.</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/NCT03262402
org study id: CAAE: 50004415.1.0000.5419
nct id: NCT03262402
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Periodontal diseases, such as chronic periodontitis (CP), frequently occur in
      immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by
      the HIV infection can justify the high frequency and the difficult in controlling the CP in
      this group of patients, raising the possibility of additional factors associated to the
      development of CP in HIV patients. The aim of this study is to determine factors that can be
      involved in the CP pathogenesis in HIV patients, including Candida spp presence, and
      biomarkers involved on the inflammatory response against the microorganisms.
Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV
      patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid
      concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis
      factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In
      order to minimize the influence of the immunosuppressive condition, patients have to present
      CD4 T lymphocytes < 200cel/mm3 blood count, non-detectable viral load and the same protocol
      of antiretroviral therapy. Additionally, investigators intend to determine the
      immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This
      study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão
      Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed
      consent.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in clinical signs of chronic periodontitis.
time frame: Baseline, 30 days and 90 days.
description: Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.
measure: Change in Candida spp carriage.
time frame: Baseline, 30 days and 90 days.
description: Number of Candida spp colonies on culture plates.
measure: Change in salivary biomarkers
time frame: Baseline, 30 days and 90 days.
description: Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
measure: Change in bacterial microbiota
time frame: Baseline, 30 days and 90 days.
description: Pyrosequencing characterization of the bacterial microbiota
arm group label: HIV-infected group
arm group type: Experimental
description: Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
arm group label: Non-HIV infected group
arm group type: Active Comparator
description: Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
intervention type: Procedure
intervention name: Basic periodontal treatment
description: Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
arm group label: HIV-infected group
arm group label: Non-HIV infected group
other name: Non-surgical periodontal treatment
criteria: 
gender: All
minimum age: 36 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ana Carolina F Motta, DDS, PhD
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
citation: Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.
PMID: 28591257
citation: Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.
PMID: 24720483
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ana Carolina Fragoso Motta, DDS, PhD
investigator title: Professor of Oral Diagnosis
mesh term: Periodontal Diseases
sharing ipd: Yes
ipd description: Individual participant data of all primary and secondary outcomes will be made available.
ipd info type: Study Protocol
ipd time frame: Data will be available within 3 months of study completion.
ipd access criteria: Data access criteria will be reviewed by the an external independent review panel.