<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/NCT03809676</url>
  </required_header>
  <id_info>
    <org_study_id>BaskentU4</org_study_id>
    <nct_id>NCT03809676</nct_id>
  </id_info>
  <brief_title>Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls</brief_title>
  <official_title>Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent 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>
      Forty heart transplant recipients and forty age and sex mathced systemically healthy patients&#xD;
      were included. Periodontal examination was performed and a questionnaire was applied to&#xD;
      record demographic data, systemic health and dental behavior data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who had heart transplantion surgery at between 2003 to 2017 were screened during&#xD;
      routine outpatient visits. The patients who have history of periodontal treatment within the&#xD;
      previous year, history of antibiotic use during the preceding 6 months, clinically non-stable&#xD;
      patients were excluded . 40 cardiac transplant patiets who met these criteria included into&#xD;
      this study. Each member of the transplant group was mathched with a patient in the&#xD;
      systemically healthy control group by age and gender and smoking status. 40 systemically&#xD;
      healthy subjects with no history of periodontal treatment within the previous year and no&#xD;
      history of antibiotic use during the preceding 6 months were recruited.&#xD;
&#xD;
      Medical Data Hospital records were reviewed and data were collected using a standardised form&#xD;
      that included demographic information (age, gender) and medical information such as smoking&#xD;
      history, presence of systemic disease, post transplant time, medication regimen/dosages.&#xD;
      Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised&#xD;
      anamnestic questionnaire. Questions were about their personal oral hygeine behaviour&#xD;
      (toothbrush, dental floss etc.), whether their dental visit was routine or&#xD;
      complaint-oriented. For the transplant group one more question about whether a dental check&#xD;
      up or comprehensive dental treatment had occured before transplantation was added.&#xD;
&#xD;
      Clinical Examination In both groups, periodontal examination was performed by one calibrated&#xD;
      periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved&#xD;
      a comprehensive periodontal examination including plaque index (PI); gingival index (GI);&#xD;
      gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment&#xD;
      level (CAL).&#xD;
&#xD;
      According to the clinical and radiographic evaluation the patients were categorized due to&#xD;
      their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis&#xD;
      or periodontitis. Patients were diagnosed with periodontally healthy if they have &lt;10%&#xD;
      bleeding sites with probing depths ≤3 mm; whereas patients who have &gt;10% bleeding sites with&#xD;
      probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm,&#xD;
      interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</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>probing depth</measure>
    <time_frame>day 1</time_frame>
    <description>measured form pocket depth to the gingival margin by periodontal probe</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Periodontal Diseases</condition>
  <condition>Heart Transplantation</condition>
  <arm_group>
    <arm_group_label>heaart transplant recipients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>periodontal examination</intervention_name>
    <description>clinical measurements were recorded</description>
    <arm_group_label>heaart transplant recipients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        40 transplant recipients and 40 systemically healthy patients were recruited&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For transplant group:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Having heart transplantation surgery&#xD;
&#xD;
          -  be clinically stable&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  History of periodontal treatment within the previous year,&#xD;
&#xD;
          -  history of antibiotic use during the preceding 6 months,&#xD;
&#xD;
          -  being clinically non-stable For healthy group Inclusion criteria&#xD;
&#xD;
          -  being systemically healthy&#xD;
&#xD;
          -  no history of periodontal treatment within the previous year&#xD;
&#xD;
          -  no history of antibiotic use during the preceding 6 months exclusion criteria Having a&#xD;
             systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yasemin Sezgin</name>
      <address>
        <city>Ankara</city>
        <state>Please Select...</state>
        <zip>06690</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Yasemin Sezgin</investigator_full_name>
    <investigator_title>asistant professor</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/NCT03809676
org study id: BaskentU4
nct id: NCT03809676
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Forty heart transplant recipients and forty age and sex mathced systemically healthy patients
      were included. Periodontal examination was performed and a questionnaire was applied to
      record demographic data, systemic health and dental behavior data.
Patients who had heart transplantion surgery at between 2003 to 2017 were screened during
      routine outpatient visits. The patients who have history of periodontal treatment within the
      previous year, history of antibiotic use during the preceding 6 months, clinically non-stable
      patients were excluded . 40 cardiac transplant patiets who met these criteria included into
      this study. Each member of the transplant group was mathched with a patient in the
      systemically healthy control group by age and gender and smoking status. 40 systemically
      healthy subjects with no history of periodontal treatment within the previous year and no
      history of antibiotic use during the preceding 6 months were recruited.

      Medical Data Hospital records were reviewed and data were collected using a standardised form
      that included demographic information (age, gender) and medical information such as smoking
      history, presence of systemic disease, post transplant time, medication regimen/dosages.
      Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised
      anamnestic questionnaire. Questions were about their personal oral hygeine behaviour
      (toothbrush, dental floss etc.), whether their dental visit was routine or
      complaint-oriented. For the transplant group one more question about whether a dental check
      up or comprehensive dental treatment had occured before transplantation was added.

      Clinical Examination In both groups, periodontal examination was performed by one calibrated
      periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved
      a comprehensive periodontal examination including plaque index (PI); gingival index (GI);
      gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment
      level (CAL).

      According to the clinical and radiographic evaluation the patients were categorized due to
      their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis
      or periodontitis. Patients were diagnosed with periodontally healthy if they have <10%
      bleeding sites with probing depths ≤3 mm; whereas patients who have >10% bleeding sites with
      probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm,
      interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26
observational model: Case-Control
time perspective: Cross-Sectional
measure: probing depth
time frame: day 1
description: measured form pocket depth to the gingival margin by periodontal probe
arm group label: heaart transplant recipients
arm group label: healthy controls
intervention type: Other
intervention name: periodontal examination
description: clinical measurements were recorded
arm group label: heaart transplant recipients
arm group label: healthy controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 11 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Yasemin Sezgin
investigator title: asistant professor
mesh term: Periodontal Diseases
sharing ipd: No