<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/NCT03009942</url>
  </required_header>
  <id_info>
    <org_study_id>03/2008-19</org_study_id>
    <nct_id>NCT03009942</nct_id>
  </id_info>
  <brief_title>Biochemical Mediators After Implant Loading</brief_title>
  <official_title>Nitric Oxide and Arginase Levels in Peri-Implant Tissues After Delayed Loading</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <brief_summary>
    <textblock>
      This study evaluates the nitric oxide and arginase levels in patients with dental implants.&#xD;
      Peri-implant sulcular fluid and saliva samples were collected after loading of the implants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of&#xD;
      peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of&#xD;
      PISF reflects two different measures and can serve as an indicator of peri-implant soft&#xD;
      tissue inflammation and/or bone response to force application and loading Arginase may reduce&#xD;
      NO production by depleting the common substrate. Thus, increased salivary arginase activities&#xD;
      detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in&#xD;
      the antibacterial property of saliva.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva</measure>
    <time_frame>Baseline and 1, 3 and 6 months after implant loading</time_frame>
    <description>The changes in nitric oxide and arginase levels after implant loading were determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>Baseline and 1, 3 and 6 months after implant loading</time_frame>
    <description>The changes in plaque index after implant loading. Plaque index was recorded for determining and classifying oral hygiene status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival index</measure>
    <time_frame>Baseline and 1, 3 and 6 months after implant loading</time_frame>
    <description>The changes in gingival index after implant loading. Gingival index was recorded for classifying and evaluating gingival inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>Baseline and 1, 3 and 6 months after implant loading</time_frame>
    <description>The changes in probing pocket depth after implant loading.Probing pocket depth was measured for determining periimplant health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>Baseline and 1, 3 and 6 months after implant loading</time_frame>
    <description>The changes in bleeding on probing after implant loading. Bleeding on probing was recorded for evaluating gingival inflammation.</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Implant Loading</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty patients with one or more implants restored with fixed crown prostheses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no&#xD;
             smoking habits, and had one or more implants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Nurdan Ozmeric</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>nitric oxide</keyword>
  <keyword>arginase</keyword>
  <keyword>loading</keyword>
  <!-- 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/NCT03009942
org study id: 03/2008-19
nct id: NCT03009942
lead sponsor: 
This study evaluates the nitric oxide and arginase levels in patients with dental implants.
      Peri-implant sulcular fluid and saliva samples were collected after loading of the implants
Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of
      peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of
      PISF reflects two different measures and can serve as an indicator of peri-implant soft
      tissue inflammation and/or bone response to force application and loading Arginase may reduce
      NO production by depleting the common substrate. Thus, increased salivary arginase activities
      detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in
      the antibacterial property of saliva.
observational model: Case-Only
time perspective: Prospective
measure: Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva
time frame: Baseline and 1, 3 and 6 months after implant loading
description: The changes in nitric oxide and arginase levels after implant loading were determined.
measure: Plaque index
time frame: Baseline and 1, 3 and 6 months after implant loading
description: The changes in plaque index after implant loading. Plaque index was recorded for determining and classifying oral hygiene status.
measure: Gingival index
time frame: Baseline and 1, 3 and 6 months after implant loading
description: The changes in gingival index after implant loading. Gingival index was recorded for classifying and evaluating gingival inflammation.
measure: Probing depth
time frame: Baseline and 1, 3 and 6 months after implant loading
description: The changes in probing pocket depth after implant loading.Probing pocket depth was measured for determining periimplant health.
measure: Bleeding on probing
time frame: Baseline and 1, 3 and 6 months after implant loading
description: The changes in bleeding on probing after implant loading. Bleeding on probing was recorded for evaluating gingival inflammation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Nurdan Ozmeric
investigator title: Professor