<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/NCT03281109</url>
  </required_header>
  <id_info>
    <org_study_id>YuzuncuYıl4</org_study_id>
    <nct_id>NCT03281109</nct_id>
  </id_info>
  <brief_title>The Effect of Menstrual Cycle On IL-6, TNF-α And Periodontal Status</brief_title>
  <official_title>The Effect of Menstrual Cycle on Periodontium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: Women's menstrual cycle is controlled by the secretion of sex hormones. Sex steroid&#xD;
      hormones are thought to be affect to periodontal tissues, wound healing, periodontal disease&#xD;
      progression and bone turn over. The aim the study is to evaluate clinical periodontal&#xD;
      parameters and interleukin- 6 (IL-6) and tumor necrosis factor alpha (TNF-α) levels in&#xD;
      gingival crevicular fluid (GCF) in menstrual cycle.&#xD;
&#xD;
      Material and methods: Twenty-five patients were included in this study clinical periodontal&#xD;
      parameters and levels of IL-6 and TNF α in gingival crevicular fluid were evaluated at three&#xD;
      periods of menstrual cycle (menstruation day (MD)-ovulation day(OD)-premenstruation day&#xD;
      (PmD)). Levels of IL-6 and TNF α in gingival crevicular fluid were determined by ELISA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Population&#xD;
&#xD;
      Sixty women were initially included in this longitudinal, prospective study in Yuzuncu Yil&#xD;
      University, Faculty of Dentistry, Department of Periodontology.&#xD;
&#xD;
      The procedure was accepted and informed consent was signed by all participants. The material&#xD;
      and method used in the trial were accepted by the Yuzuncu Yil University Ethics Committee and&#xD;
      were found to conform to the guidelines issued in the Declaration of Helsinki. To standardize&#xD;
      the effect of plaque accumulation on the tested parameters, subjects were given oral hygiene&#xD;
      instructions before the study.&#xD;
&#xD;
      Clinical Procedures, and Measurements&#xD;
&#xD;
      All subjects were scheduled for periodontal measurements and GCF sampling on the specific&#xD;
      days determined as follows: 1) menstruation day (MD); on days 2-3 of menstruation 2)&#xD;
      ovulation day (OD); detected by saliva fertility microscope 12-14 days of menstrual cycle and&#xD;
      3) premenstruation day (PmD); 22-24 days of menstruation cycle.&#xD;
&#xD;
      The subjects evaluated the study criteria in terms of the duration of a regular menstrual&#xD;
      cycle (28 ± 3 d) and were followed up for three menstrual cycles. Five participants were&#xD;
      excluded from the study if their menstrual cycles were longer or shorter than 28 ± 3 d for&#xD;
      the last 12 months.&#xD;
&#xD;
      Donna ® Saliva Fertility Tester was used to detect the ovulation day. Patients also made&#xD;
      their own fever measurement and confirmed the ovulation day. A small amount of saliva was&#xD;
      placed onto microscope and after 5 minutes results were evaluated according to manufacturer's&#xD;
      instructions. The outside of microscope lens cleaned with alcohol and a cotton swab after&#xD;
      each use.&#xD;
&#xD;
      Periodontal measurements were performed for all patients at each of the three time points&#xD;
      from index teeth. Periodontal measurements were: 1) plaque index (PI) (according to Silness&#xD;
      and Löe index) 9: measured at six sites around each tooth; the highest score per tooth was&#xD;
      recorded; 2) gingival index (GI) (according to Löe and Silness index) 10: measured at six&#xD;
      sites around each tooth; the highest score per tooth was recorded; 3) probing depth (PD):&#xD;
      measured at six sites around each tooth.&#xD;
&#xD;
      The GCF samples were obtained for 30 seconds from the mesiobuccal gingival sulcus of teeth&#xD;
      using periodontal paper strips . The samples were taken 3 hours after the patients brush&#xD;
      their teeth in the morning.&#xD;
&#xD;
      To avoid irritation of the periodontal pocket epithelium, the clinical measurements were&#xD;
      obtained after the GCF samples collecting. The area was isolated with cotton rolls. All paper&#xD;
      strips were stored in phosphate buffered solution. Paper points contaminated with blood and&#xD;
      saliva were not used for study. GCF samples were stored at -80 °C for laboratory analyses.&#xD;
      GCF samples were analyzed for IL-6 and TNF-α using commercially available sandwich&#xD;
      enzyme-linked immunosorbent assay according to the manufacturer's instructions. Results were&#xD;
      reported as concentrations of IL-6 and TNF-α in GCF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>periodontal clinical parameters</measure>
    <time_frame>1 menstrual cycle (approximately 1 month) every patient follow up</time_frame>
    <description>gingival index: according to Silness and Löe gingival index plaque index: according to Löe and Silness plaque index probing depth the distance between gingival margin to periodontal sulcus bottom (mm) IL-6 concentration (pg/microliter) TNF- alpha concentration (pg/microliter)</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Menstrual Cycle-Associated Gingivitis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>diagnosis</intervention_name>
    <description>diagnosis with ELISA</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        25 women were included in this longitudinal, prospective study in Yuzuncu Yil University,&#xD;
        Faculty of Dentistry, Department of Periodontology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Inclusion criteria were:&#xD;
&#xD;
          1. premenopausal women, age 20-35 to years;&#xD;
&#xD;
          2. normal and steady menstrual cycle (25 to 31 days long);&#xD;
&#xD;
          3. available for clinical examination;&#xD;
&#xD;
          4. non-smoking;&#xD;
&#xD;
          5. antibiotic therapy or use of nonsteroidal anti-inflammatory drugs within the past 6&#xD;
             months;&#xD;
&#xD;
          6. healthy systemic status;&#xD;
&#xD;
          7. normal body mass index;&#xD;
&#xD;
          8. healthy periodontium.&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria were as follows:&#xD;
&#xD;
          1. pregnancy;&#xD;
&#xD;
          2. use of oral contraceptives;&#xD;
&#xD;
          3. metabolic or systemic condition that might affect the periodontium;&#xD;
&#xD;
          4. antibiotic therapy or use of nonsteroidal anti-inflammatory drugs within the past 6&#xD;
             months;&#xD;
&#xD;
          5. periodontitis;&#xD;
&#xD;
          6. smoking and&#xD;
&#xD;
          7. with the diagnosis of polycystic over or hyperandrogenism according to Rotterdam&#xD;
             diagnostic criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only Female</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>hacer sahin aydinyurt</last_name>
    <role>Study Director</role>
    <affiliation>yuzuncu yil universtiy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yuzuncu Yıl University</name>
      <address>
        <city>VAN</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Hacer Sahin Aydinyurt</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>menstrual cycle</keyword>
  <keyword>gingivitis</keyword>
  <keyword>interleukin 1</keyword>
  <keyword>tumor necrosis factor alpha</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</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/NCT03281109
org study id: YuzuncuYıl4
nct id: NCT03281109
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: Women's menstrual cycle is controlled by the secretion of sex hormones. Sex steroid
      hormones are thought to be affect to periodontal tissues, wound healing, periodontal disease
      progression and bone turn over. The aim the study is to evaluate clinical periodontal
      parameters and interleukin- 6 (IL-6) and tumor necrosis factor alpha (TNF-α) levels in
      gingival crevicular fluid (GCF) in menstrual cycle.

      Material and methods: Twenty-five patients were included in this study clinical periodontal
      parameters and levels of IL-6 and TNF α in gingival crevicular fluid were evaluated at three
      periods of menstrual cycle (menstruation day (MD)-ovulation day(OD)-premenstruation day
      (PmD)). Levels of IL-6 and TNF α in gingival crevicular fluid were determined by ELISA.
Study Population

      Sixty women were initially included in this longitudinal, prospective study in Yuzuncu Yil
      University, Faculty of Dentistry, Department of Periodontology.

      The procedure was accepted and informed consent was signed by all participants. The material
      and method used in the trial were accepted by the Yuzuncu Yil University Ethics Committee and
      were found to conform to the guidelines issued in the Declaration of Helsinki. To standardize
      the effect of plaque accumulation on the tested parameters, subjects were given oral hygiene
      instructions before the study.

      Clinical Procedures, and Measurements

      All subjects were scheduled for periodontal measurements and GCF sampling on the specific
      days determined as follows: 1) menstruation day (MD); on days 2-3 of menstruation 2)
      ovulation day (OD); detected by saliva fertility microscope 12-14 days of menstrual cycle and
      3) premenstruation day (PmD); 22-24 days of menstruation cycle.

      The subjects evaluated the study criteria in terms of the duration of a regular menstrual
      cycle (28 ± 3 d) and were followed up for three menstrual cycles. Five participants were
      excluded from the study if their menstrual cycles were longer or shorter than 28 ± 3 d for
      the last 12 months.

      Donna ® Saliva Fertility Tester was used to detect the ovulation day. Patients also made
      their own fever measurement and confirmed the ovulation day. A small amount of saliva was
      placed onto microscope and after 5 minutes results were evaluated according to manufacturer's
      instructions. The outside of microscope lens cleaned with alcohol and a cotton swab after
      each use.

      Periodontal measurements were performed for all patients at each of the three time points
      from index teeth. Periodontal measurements were: 1) plaque index (PI) (according to Silness
      and Löe index) 9: measured at six sites around each tooth; the highest score per tooth was
      recorded; 2) gingival index (GI) (according to Löe and Silness index) 10: measured at six
      sites around each tooth; the highest score per tooth was recorded; 3) probing depth (PD):
      measured at six sites around each tooth.

      The GCF samples were obtained for 30 seconds from the mesiobuccal gingival sulcus of teeth
      using periodontal paper strips . The samples were taken 3 hours after the patients brush
      their teeth in the morning.

      To avoid irritation of the periodontal pocket epithelium, the clinical measurements were
      obtained after the GCF samples collecting. The area was isolated with cotton rolls. All paper
      strips were stored in phosphate buffered solution. Paper points contaminated with blood and
      saliva were not used for study. GCF samples were stored at -80 °C for laboratory analyses.
      GCF samples were analyzed for IL-6 and TNF-α using commercially available sandwich
      enzyme-linked immunosorbent assay according to the manufacturer's instructions. Results were
      reported as concentrations of IL-6 and TNF-α in GCF.
observational model: Case-Only
time perspective: Prospective
measure: periodontal clinical parameters
time frame: 1 menstrual cycle (approximately 1 month) every patient follow up
description: gingival index: according to Silness and Löe gingival index plaque index: according to Löe and Silness plaque index probing depth the distance between gingival margin to periodontal sulcus bottom (mm) IL-6 concentration (pg/microliter) TNF- alpha concentration (pg/microliter)
intervention type: Diagnostic Test
intervention name: diagnosis
description: diagnosis with ELISA
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only Female
minimum age: 20 Years
maximum age: 29 Years
last name: hacer sahin aydinyurt
role: Study Director
affiliation: yuzuncu yil universtiy
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Hacer Sahin Aydinyurt
investigator title: assistant professor
mesh term: Gingivitis
sharing ipd: Undecided