<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/NCT02184962</url>
  </required_header>
  <id_info>
    <org_study_id>MEV-2030</org_study_id>
    <secondary_id>UNC-2013</secondary_id>
    <nct_id>NCT02184962</nct_id>
  </id_info>
  <brief_title>Periodontal Disease and Post-menopausal Osteoporosis</brief_title>
  <official_title>&quot;Levels of RANKL and OPG in Gingival Crevicular Fluid of Patients With Post-menopausal Osteoporosis / Osteopenia and Periodontal Disease.&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Córdoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their&#xD;
      relationship in gingival crevicular fluid of post-menopausal women with&#xD;
      osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that&#xD;
      the use of bisphosphonates in periodontal disease.&#xD;
&#xD;
      Study hypothesis:&#xD;
&#xD;
      &quot;The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease&#xD;
      affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis&#xD;
      processes &quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic&#xD;
      periodontitis were studied. Samples of gingival crevicular fluid were collected by paper&#xD;
      strips and ELISA test was conducted to determine the total concentration of RANKL, OPG, and&#xD;
      then obtain the values of the RANKL / OPG ratio. We analyzed 66 samples of gingival&#xD;
      crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia /&#xD;
      osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites&#xD;
      obtained of 14 controls patients with normal osseous condition.&#xD;
&#xD;
      Statistical analyzes were computed and analyzed using Graphpad Software. To determine if the&#xD;
      data correspond to a normal distribution the D'Agostino-Pearson test was used. The values of&#xD;
      cytokines (RANKL and OPG) and its ratio (RANKL / OPG) were compared using Mann-Whitney Test t&#xD;
      U. Analysis Spearman correlation and linear regression for statistic was also performed to&#xD;
      determine whether there was any relationship between the variables analyzed. It was&#xD;
      considered as statistically significant p value ≤ 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>levels of RANKL and OPG</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">81</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Osteopenia</condition>
  <condition>Periodontal Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with osteopenia / osteoporosis and controls with normal osseous condition. Both&#xD;
        groups with chronic periodontitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA).&#xD;
&#xD;
               -  Control group: post-menopausal women with periodontal disease and normal osseous&#xD;
                  condition.&#xD;
&#xD;
               -  Study group: post-menopausal womens with periodontal disease and&#xD;
                  osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or&#xD;
                  ibandronate 150 mg) for longer than 3 months before the study and another.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of aggressive periodontitis and had received any periodontal&#xD;
             treatment when they entered the study&#xD;
&#xD;
          -  Patients with any systemic illness (except osteopenia/osteoporosis)&#xD;
&#xD;
          -  Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6&#xD;
             months prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María E Verde, Odontóloga</last_name>
    <role>Principal Investigator</role>
    <affiliation>Facultad de Odontología - UNC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Facultad de Odontología - Universidad Nacional de Córdoba</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional de Córdoba</investigator_affiliation>
    <investigator_full_name>María Eugenia Verde</investigator_full_name>
    <investigator_title>María Eugenia Verde - Cátedra de Periodoncia A - UNC</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02184962
org study id: MEV-2030
secondary id: UNC-2013
nct id: NCT02184962
lead sponsor: 
has dmc: Yes
The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their
      relationship in gingival crevicular fluid of post-menopausal women with
      osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that
      the use of bisphosphonates in periodontal disease.

      Study hypothesis:

      "The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease
      affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis
      processes "
81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic
      periodontitis were studied. Samples of gingival crevicular fluid were collected by paper
      strips and ELISA test was conducted to determine the total concentration of RANKL, OPG, and
      then obtain the values of the RANKL / OPG ratio. We analyzed 66 samples of gingival
      crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia /
      osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites
      obtained of 14 controls patients with normal osseous condition.

      Statistical analyzes were computed and analyzed using Graphpad Software. To determine if the
      data correspond to a normal distribution the D'Agostino-Pearson test was used. The values of
      cytokines (RANKL and OPG) and its ratio (RANKL / OPG) were compared using Mann-Whitney Test t
      U. Analysis Spearman correlation and linear regression for statistic was also performed to
      determine whether there was any relationship between the variables analyzed. It was
      considered as statistically significant p value ≤ 0.05.
observational model: Case-Control
time perspective: Cross-Sectional
measure: levels of RANKL and OPG
time frame: one year
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: María E Verde, Odontóloga
role: Principal Investigator
affiliation: Facultad de Odontología - UNC
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional de Córdoba
investigator full name: María Eugenia Verde
investigator title: María Eugenia Verde - Cátedra de Periodoncia A - UNC
mesh term: Osteoporosis
mesh term: Bone Diseases, Metabolic
mesh term: Osteoporosis, Postmenopausal
mesh term: Periodontal Diseases