<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/NCT04407026</url>
  </required_header>
  <id_info>
    <org_study_id>2017/009</org_study_id>
    <nct_id>NCT04407026</nct_id>
  </id_info>
  <brief_title>Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases</brief_title>
  <official_title>Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes 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>
      Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host&#xD;
      immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory&#xD;
      proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the&#xD;
      levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of&#xD;
      patients with gingivitis, stage 3 periodontitis and healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of one hundred participants were enrolled for the study. All individuals were&#xD;
      assessed clinically and radiographically. Full-mouth clinical periodontal examinations were&#xD;
      performed by the measurements of probing depth (PD), clinical attachment level (CAL),&#xD;
      gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements&#xD;
      were recorded at six sites around each tooth with a manual periodontal probe. The&#xD;
      participants were categorized into three groups: healthy controls (n=25), patients with&#xD;
      gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva&#xD;
      and serum samples were collected from each participant one day after the clinical periodontal&#xD;
      measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the&#xD;
      enzyme-linked immunosorbent assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels</measure>
    <time_frame>one day after the clinical periodontal measurements</time_frame>
    <description>Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP&lt;10% and no sign of clinical attachment loss and radiographic alveolar bone destruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gingivitis</arm_group_label>
    <description>Gingivitis group (n=25) had PD≤3 mm with BOP&gt;50% in the entire mouth, and no clinical attachment loss or alveolar bone loss.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 3 periodontitis</arm_group_label>
    <description>Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>biofluids</intervention_name>
    <description>Gingival crevicular fluid, saliva and serum samples were obtained.</description>
    <arm_group_label>Gingivitis</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Stage 3 periodontitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gingival crevicular fluid, saliva and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy controls included volunteers with clinically healthy periodontium who had BOP &lt; 10%&#xD;
        and PD ≤ 3 mm, no sites with attachment loss or radiographic sign of alveolar bone&#xD;
        destruction. Gingivitis patients showed PD ≤ 3 mm with BOP &gt; 50% in the entire mouth as&#xD;
        well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Stage 3)&#xD;
        had PD ≥ 6 mm, interdental CAL ≥ 5 mm affecting 30% of the teeth or more and showed&#xD;
        radiographic bone loss. They showed also no more than 4 teeth loss due to periodontitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy individuals&#xD;
&#xD;
          -  No history of smoking&#xD;
&#xD;
          -  Individuals between the ages of 25-50 years&#xD;
&#xD;
          -  Having at least 20 natural teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid&#xD;
             arthritis, immunological disorders, collagen-metabolic diseases, cancer)&#xD;
&#xD;
          -  A history of smoking&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  A history of surgical/non-surgical periodontal therapy in the past 1 year&#xD;
&#xD;
          -  Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other&#xD;
             pharmacological treatment) in the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Zeynep Pinar Keles Yucel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Giresun University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeynep Pinar Keles Yucel</name>
      <address>
        <city>Giresun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Giresun University</investigator_affiliation>
    <investigator_full_name>Zeynep Pinar KELES YUCEL</investigator_full_name>
    <investigator_title>Assistant Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04407026
org study id: 2017/009
nct id: NCT04407026
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host
      immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory
      proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the
      levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of
      patients with gingivitis, stage 3 periodontitis and healthy individuals.
A total of one hundred participants were enrolled for the study. All individuals were
      assessed clinically and radiographically. Full-mouth clinical periodontal examinations were
      performed by the measurements of probing depth (PD), clinical attachment level (CAL),
      gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements
      were recorded at six sites around each tooth with a manual periodontal probe. The
      participants were categorized into three groups: healthy controls (n=25), patients with
      gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva
      and serum samples were collected from each participant one day after the clinical periodontal
      measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the
      enzyme-linked immunosorbent assay.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels
time frame: one day after the clinical periodontal measurements
description: Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.
arm group label: Healthy
description: Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction.
arm group label: Gingivitis
description: Gingivitis group (n=25) had PD≤3 mm with BOP>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss.
arm group label: Stage 3 periodontitis
description: Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss.
intervention type: Biological
intervention name: biofluids
description: Gingival crevicular fluid, saliva and serum samples were obtained.
arm group label: Gingivitis
arm group label: Healthy
arm group label: Stage 3 periodontitis
Gingival crevicular fluid, saliva and serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 49 Years
last name: Zeynep Pinar Keles Yucel
role: Principal Investigator
affiliation: Giresun University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Giresun University
investigator full name: Zeynep Pinar KELES YUCEL
investigator title: Assistant Prof.
mesh term: Periodontal Diseases
sharing ipd: No