<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/NCT04430764</url>
  </required_header>
  <id_info>
    <org_study_id>2014/Diş/019</org_study_id>
    <nct_id>NCT04430764</nct_id>
  </id_info>
  <brief_title>The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels</brief_title>
  <official_title>The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to investigate the effect of smoking and non-surgical periodontal treatment&#xD;
      on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis.&#xD;
      Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control&#xD;
      subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal&#xD;
      treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and&#xD;
      EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment.&#xD;
      GCF CyPA and EMMPRIN levels were analyzed by ELISA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gingival crevicular fluid CypA total amounts</measure>
    <time_frame>Baseline, 1 week, 1., 3. months</time_frame>
    <description>GCF CyPA levels were analyzed by ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gingival crevicular fluid EMMPRIN total amounts</measure>
    <time_frame>Baseline, 1 week, 1., 3. months</time_frame>
    <description>GCF EMMPRIN levels were analyzed by ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in probing depth</measure>
    <time_frame>Baseline, 1., 3. months</time_frame>
    <description>Probing depth was measured with Williams periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bleeding on probing</measure>
    <time_frame>Baseline, 1., 3. months</time_frame>
    <description>Bleeding on probing was evaluated the presence or absense following bleeding upon probing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Smoking</condition>
  <condition>Periodontitis</condition>
  <condition>Non-surgical Periodontal Treatment</condition>
  <arm_group>
    <arm_group_label>smoker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>non-smoker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>non-surgical periodontal treatment</intervention_name>
    <description>Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.</description>
    <arm_group_label>non-smoker</arm_group_label>
    <arm_group_label>smoker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generalized periodontitis with stage III-IV &amp; Grade B&#xD;
&#xD;
          -  no systemic and periodontal diseases&#xD;
&#xD;
          -  smokers (minimum 10 cigarettes per day for at least ten years)&#xD;
&#xD;
          -  non-smokers (never smoked)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic diseases&#xD;
&#xD;
          -  Infectious diseases&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Having periodontal treatment during the last 6 months&#xD;
&#xD;
          -  Having antibiotic treatment within the past 3 months&#xD;
&#xD;
          -  Former smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Years</minimum_age>
    <maximum_age>61 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Oya Turkoglu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04430764
org study id: 2014/Diş/019
nct id: NCT04430764
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the effect of smoking and non-surgical periodontal treatment
      on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis.
      Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control
      subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal
      treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and
      EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment.
      GCF CyPA and EMMPRIN levels were analyzed by ELISA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in gingival crevicular fluid CypA total amounts
time frame: Baseline, 1 week, 1., 3. months
description: GCF CyPA levels were analyzed by ELISA
measure: Change in gingival crevicular fluid EMMPRIN total amounts
time frame: Baseline, 1 week, 1., 3. months
description: GCF EMMPRIN levels were analyzed by ELISA
measure: Change in probing depth
time frame: Baseline, 1., 3. months
description: Probing depth was measured with Williams periodontal probe.
measure: Change in bleeding on probing
time frame: Baseline, 1., 3. months
description: Bleeding on probing was evaluated the presence or absense following bleeding upon probing.
arm group label: smoker
arm group type: Experimental
arm group label: non-smoker
arm group type: Active Comparator
intervention type: Procedure
intervention name: non-surgical periodontal treatment
description: Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.
arm group label: non-smoker
arm group label: smoker
criteria: 
gender: All
minimum age: 29 Years
maximum age: 61 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Oya Turkoglu
investigator title: Professor
mesh term: Periodontitis
sharing ipd: Undecided