<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/NCT04496570</url>
  </required_header>
  <id_info>
    <org_study_id>Ordu University Dental Faculty</org_study_id>
    <nct_id>NCT04496570</nct_id>
  </id_info>
  <brief_title>Resolvin D1 Levels in Patients With Periodontitis</brief_title>
  <official_title>The Role of Resolvin D1 in Maintaining Oral Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</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>
      The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival&#xD;
      crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to&#xD;
      investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.&#xD;
&#xD;
      A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements,&#xD;
      GCF and saliva samples were collected from each individual at baseline and 1 month after&#xD;
      NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA)&#xD;
      method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical parameter (resolvin D1)</measure>
    <time_frame>Baseline and 1 month after NSPT</time_frame>
    <description>The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>Baseline and 1 month after NSPT</time_frame>
    <description>The changes in probing pocket depth after periodontal treatment were evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level (CAL)</measure>
    <time_frame>Baseline and 1 month after NSPT</time_frame>
    <description>The changes in CAL after periodontal treatment were evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index (PI)</measure>
    <time_frame>Baseline and 1 month after NSPT</time_frame>
    <description>The changes in PI after periodontal treatment were evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival index (GI)</measure>
    <time_frame>Baseline and 1 month after NSPT</time_frame>
    <description>The changes in GI after periodontal treatment were evaluated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Periodontitis patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy individuals</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>periodontal therapy</intervention_name>
    <description>Non surgical periodontal therapy was performed to patients with peridontitis</description>
    <arm_group_label>Periodontitis patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 3, Grade B and generalized periodontitis patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  excessive forces;&#xD;
&#xD;
          -  presence of systemic diseases&#xD;
&#xD;
          -  administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies&#xD;
             within the previous 6 months&#xD;
&#xD;
          -  having received non-surgical periodontal treatment within the past 6 months&#xD;
&#xD;
          -  allergy or sensitivity to any drug,&#xD;
&#xD;
          -  pregnancy, lactation&#xD;
&#xD;
          -  current and former use of tobacco.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ordu University</name>
      <address>
        <city>Ordu</city>
        <zip>52200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Ceren Gökmenoğlu</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>gingival crevicular fluid</keyword>
  <keyword>resolvin D1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</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/NCT04496570
org study id: Ordu University Dental Faculty
nct id: NCT04496570
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival
      crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to
      investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.

      A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements,
      GCF and saliva samples were collected from each individual at baseline and 1 month after
      NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA)
      method.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Biochemical parameter (resolvin D1)
time frame: Baseline and 1 month after NSPT
description: The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
measure: Probing pocket depth
time frame: Baseline and 1 month after NSPT
description: The changes in probing pocket depth after periodontal treatment were evaluated
measure: Clinical attachment level (CAL)
time frame: Baseline and 1 month after NSPT
description: The changes in CAL after periodontal treatment were evaluated
measure: Plaque index (PI)
time frame: Baseline and 1 month after NSPT
description: The changes in PI after periodontal treatment were evaluated
measure: Gingival index (GI)
time frame: Baseline and 1 month after NSPT
description: The changes in GI after periodontal treatment were evaluated
arm group label: Periodontitis patients
arm group type: Active Comparator
description: gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment
arm group label: Healthy individuals
arm group type: No Intervention
description: gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions
intervention type: Procedure
intervention name: periodontal therapy
description: Non surgical periodontal therapy was performed to patients with peridontitis
arm group label: Periodontitis patients
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Ceren Gökmenoğlu
investigator title: Principal investigator
mesh term: Periodontitis