<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/NCT03027622</url>
  </required_header>
  <id_info>
    <org_study_id>3/5-2015</org_study_id>
    <nct_id>NCT03027622</nct_id>
  </id_info>
  <brief_title>The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis</brief_title>
  <official_title>The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patints With Mild Pericoronitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The complications that could occur during or after the extraction of the mandibular third&#xD;
      molar teeth with pericoronitis affect patient's life quality considerably. Various scales are&#xD;
      used to reveal how much the life quality of patients is affected this treatment. The aim of&#xD;
      this study is to identify the long term life quality of patients through the OHIP-14 TR scale&#xD;
      without removing the mandibular third molar teeth with mild pericoronitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing the lenght stay in the mouth at a maximum rate and following the patient up after&#xD;
      the necessary treatment and information procedures are completed. As a result of clinical and&#xD;
      radiographical examinations fifty-five voluntary patients whose average age was 24 and who&#xD;
      have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild&#xD;
      pericoronitis were included in the study.After the patients in the study filled out the form&#xD;
      including their contact and demographic data and dental symptomsand completed OHIP-14 TR&#xD;
      scale which last about 5 minutes, their curretage and operculectomy treatments were done&#xD;
      under local anesthesia. The patients were invited for reexamination on seventh day after the&#xD;
      treatment. Also, an active patient follow up about life quality was performed by phone at&#xD;
      1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR&#xD;
      scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total score of OHIP-14 TR at the begining of experiment</measure>
    <time_frame>first month</time_frame>
    <description>numeric values of OHIP-14 TR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total score of OHIP-14 TR at third months</measure>
    <time_frame>third months</time_frame>
    <description>numeric values of OHIP-14 TR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score of OHIP-14 TR at sixth months</measure>
    <time_frame>sixth months</time_frame>
    <description>numeric values of OHIP-14 TR</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Pericoronitis</condition>
  <arm_group>
    <arm_group_label>long term quality of life</arm_group_label>
    <description>to evaluate conservatively managed third molars with mild pericoronitis at first, third and sixth months by using OHIP-14 TR</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>quality of life in the patients with mild pericoronitis</intervention_name>
    <description>active surviallence by OHIP-14 TR after treatment</description>
    <arm_group_label>long term quality of life</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        55 patients diagnosed with pericoronitis affecting third molars&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having the first episode of mild pericoronitis, having a good periodontal health,&#xD;
             having an age between 18 and 25 years&#xD;
&#xD;
          -  having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower&#xD;
             third molar, having no systemic discomfort and being in the ASA I and ASAII&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having no lower third molar with a vertical position&#xD;
&#xD;
          -  having a systemic discomfort&#xD;
&#xD;
          -  having moderate to severe pericoronitis&#xD;
&#xD;
          -  having a history antibiotics or NSAIID&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Cahit UCOK</investigator_full_name>
    <investigator_title>DDS PhD, clinical professor</investigator_title>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>pericoronitis</keyword>
  <keyword>third molar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pericoronitis</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/NCT03027622
org study id: 3/5-2015
nct id: NCT03027622
lead sponsor: 
has dmc: No
The complications that could occur during or after the extraction of the mandibular third
      molar teeth with pericoronitis affect patient's life quality considerably. Various scales are
      used to reveal how much the life quality of patients is affected this treatment. The aim of
      this study is to identify the long term life quality of patients through the OHIP-14 TR scale
      without removing the mandibular third molar teeth with mild pericoronitis.
Increasing the lenght stay in the mouth at a maximum rate and following the patient up after
      the necessary treatment and information procedures are completed. As a result of clinical and
      radiographical examinations fifty-five voluntary patients whose average age was 24 and who
      have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild
      pericoronitis were included in the study.After the patients in the study filled out the form
      including their contact and demographic data and dental symptomsand completed OHIP-14 TR
      scale which last about 5 minutes, their curretage and operculectomy treatments were done
      under local anesthesia. The patients were invited for reexamination on seventh day after the
      treatment. Also, an active patient follow up about life quality was performed by phone at
      1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR
      scale.
observational model: Cohort
time perspective: Prospective
measure: Total score of OHIP-14 TR at the begining of experiment
time frame: first month
description: numeric values of OHIP-14 TR
measure: Total score of OHIP-14 TR at third months
time frame: third months
description: numeric values of OHIP-14 TR
measure: Total score of OHIP-14 TR at sixth months
time frame: sixth months
description: numeric values of OHIP-14 TR
arm group label: long term quality of life
description: to evaluate conservatively managed third molars with mild pericoronitis at first, third and sixth months by using OHIP-14 TR
intervention type: Behavioral
intervention name: quality of life in the patients with mild pericoronitis
description: active surviallence by OHIP-14 TR after treatment
arm group label: long term quality of life
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Cahit UCOK
investigator title: DDS PhD, clinical professor
mesh term: Pericoronitis
sharing ipd: Undecided