<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/NCT02190773</url>
  </required_header>
  <id_info>
    <org_study_id>RANKL</org_study_id>
    <nct_id>NCT02190773</nct_id>
  </id_info>
  <brief_title>Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System</brief_title>
  <official_title>Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <brief_summary>
    <textblock>
      In the present clinical study including chronic, aggressive periodontitis and healthy&#xD;
      individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),&#xD;
      Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after&#xD;
      surgical periodontal treatment and search out the relationship of clinical parameters with&#xD;
      these cytokine levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RANKL (pmol) level in GCF</measure>
    <time_frame>Baseline-3 months</time_frame>
    <description>Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OPG level (pg) in GCF</measure>
    <time_frame>Baseline-3 months</time_frame>
    <description>Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RANKL/OPG ratio</measure>
    <time_frame>Baseline - 3months</time_frame>
    <description>RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-1β (pg) levels in GCF</measure>
    <time_frame>Baseline, 3 months after treatment</time_frame>
    <description>Changes in IL-1β levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive Periodontitis groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Il-10 (pg) levels in GCF</measure>
    <time_frame>Baseline-3 months</time_frame>
    <description>Changes in IL-10 levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Chronic Periodontitis</condition>
  <condition>Aggressive Periodontitis</condition>
  <condition>RANKL/OPG Ratio</condition>
  <condition>Gingival Crevicular Fluid</condition>
  <arm_group>
    <arm_group_label>Chronic periodontitis</arm_group_label>
    <description>Surgical periodontal treatment and GCF collection 3 months after treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Agressive periodontitis</arm_group_label>
    <description>Surgical periodontal treatment and GCF collection 3 months after treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Periodontally healthy individuals</description>
  </arm_group>
  <biospec_descr>
    <textblock>
      Gingival Crevicular fluid (GCF) is collected at baseline and 3 months after the surgical&#xD;
      treatment.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe&#xD;
        University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic periodontitis having at least 5mm or more probing depth and aggressive&#xD;
             periodontitis patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known systemic disorder, used antibiotics and/or anti-inflammatory medications,&#xD;
             had periodontal treatment in the last 3 months and all of them were non smokers.&#xD;
             Subjects who were lactating and pregnant were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 13, 2014</last_update_submitted>
  <last_update_submitted_qc>July 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ezel Berker</investigator_full_name>
    <investigator_title>Ezel Berker</investigator_title>
  </responsible_party>
  <keyword>Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid</keyword>
  <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>Aggressive Periodontitis</mesh_term>
    <mesh_term>Aggression</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/NCT02190773
org study id: RANKL
nct id: NCT02190773
lead sponsor: 
In the present clinical study including chronic, aggressive periodontitis and healthy
      individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),
      Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after
      surgical periodontal treatment and search out the relationship of clinical parameters with
      these cytokine levels.
observational model: Case-Control
time perspective: Prospective
measure: RANKL (pmol) level in GCF
time frame: Baseline-3 months
description: Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
measure: OPG level (pg) in GCF
time frame: Baseline-3 months
description: Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
measure: RANKL/OPG ratio
time frame: Baseline - 3months
description: RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
measure: IL-1β (pg) levels in GCF
time frame: Baseline, 3 months after treatment
description: Changes in IL-1β levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive Periodontitis groups
measure: Il-10 (pg) levels in GCF
time frame: Baseline-3 months
description: Changes in IL-10 levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
arm group label: Chronic periodontitis
description: Surgical periodontal treatment and GCF collection 3 months after treatment
arm group label: Agressive periodontitis
description: Surgical periodontal treatment and GCF collection 3 months after treatment.
arm group label: Control group
description: Periodontally healthy individuals
Gingival Crevicular fluid (GCF) is collected at baseline and 3 months after the surgical
      treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ezel Berker
investigator title: Ezel Berker
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Aggressive Periodontitis
mesh term: Aggression