<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/NCT04409028</url>
  </required_header>
  <id_info>
    <org_study_id>12122018/100</org_study_id>
    <nct_id>NCT04409028</nct_id>
  </id_info>
  <brief_title>The Effect of Coronal Restoration Type on Satisfaction Patients.</brief_title>
  <acronym>OHIP-14</acronym>
  <official_title>The Effect of Coronal Restoration Type of Endodontic Treated Posterior Teeth on Quality of Life and Satisfaction Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Melek ÇAM</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Okan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Okan 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>
      This study aimed to evaluate the impacts of coronal restorations of endodontic treated&#xD;
      posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who&#xD;
      were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and&#xD;
      files of patients who received endodontic treatment in our faculty between 2018 and 2020 were&#xD;
      reviewed and chosen. The patients included in the study had been treated by the same&#xD;
      endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be&#xD;
      either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the&#xD;
      data of patient files and database systems were combined, 76 patients were deemed fit for&#xD;
      this study. The patients were contacted by phone to request participation in the study. A&#xD;
      rendezvous was created for the patients who agreed to get involved in the study, and those&#xD;
      who came to the appointment filled in the questionnaires. Demographics, the semantic&#xD;
      differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18&#xD;
      software.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan&#xD;
      University and conducted both at its Endodontics and Restorative Departments of Dentistry&#xD;
      Faculty. A query of the Nucleus database (a patient management software) was performed to&#xD;
      identify dental charts of patients who received endodontic treatment between December 2018&#xD;
      and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and&#xD;
      then selected the same endodontic specialists' patients. A total of 400 teeth were identified&#xD;
      for screening. Next, a specified restorative dentistry specialist's patient searched within&#xD;
      these patients, and 150 patients were obtained. The study was completed with 68 participants&#xD;
      (n=34 each). Then data and radiographs of patients were checked out for the eligibility&#xD;
      criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality life of patients</measure>
    <time_frame>one year</time_frame>
    <description>the scores given by participants to OHIP-14 survey</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>indirect restoration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>direct restoration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronal restoration</intervention_name>
    <description>A restorative material like composite resin is condensed into the cavity of teeth.</description>
    <arm_group_label>direct restoration</arm_group_label>
    <arm_group_label>indirect restoration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) patients who received only one nonsurgical, single visit primary root canal&#xD;
             therapy to one posterior tooth (premolar/molar) which has no periapical lesion and&#xD;
             Class I/II coronal restoration, (2) patient's restoration had occlusal function for a&#xD;
             minimum of 1 year, (3) patients who were ≥18 years old and no pregnancy or&#xD;
             breastfeeding status (4) patients who had good oral hygiene and full dentition (5)&#xD;
             patients who were on the American Society of Anesthesiology I and II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with physical disabilities and communication difficulties, periapical&#xD;
             abscess, sinus tract, dental caries were excluded from the study. Patients who had&#xD;
             other dental treatments such prosthetic crowns, implants, dental bleaching, filling&#xD;
             were not included in the study. Those with open apex teeth were also excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Okan University</name>
      <address>
        <city>İstanbul</city>
        <state>Tuzla</state>
        <zip>34947</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Okan University</investigator_affiliation>
    <investigator_full_name>Melek ÇAM</investigator_full_name>
    <investigator_title>Assist. Prof.</investigator_title>
  </responsible_party>
  <keyword>OHIP-14</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Endodontically treated teeth</keyword>
  <keyword>Composite resin</keyword>
  <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/NCT04409028
org study id: 12122018/100
nct id: NCT04409028
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the impacts of coronal restorations of endodontic treated
      posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who
      were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and
      files of patients who received endodontic treatment in our faculty between 2018 and 2020 were
      reviewed and chosen. The patients included in the study had been treated by the same
      endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be
      either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the
      data of patient files and database systems were combined, 76 patients were deemed fit for
      this study. The patients were contacted by phone to request participation in the study. A
      rendezvous was created for the patients who agreed to get involved in the study, and those
      who came to the appointment filled in the questionnaires. Demographics, the semantic
      differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18
      software.
This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan
      University and conducted both at its Endodontics and Restorative Departments of Dentistry
      Faculty. A query of the Nucleus database (a patient management software) was performed to
      identify dental charts of patients who received endodontic treatment between December 2018
      and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and
      then selected the same endodontic specialists' patients. A total of 400 teeth were identified
      for screening. Next, a specified restorative dentistry specialist's patient searched within
      these patients, and 150 patients were obtained. The study was completed with 68 participants
      (n=34 each). Then data and radiographs of patients were checked out for the eligibility
      criteria.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Quality life of patients
time frame: one year
description: the scores given by participants to OHIP-14 survey
arm group label: indirect restoration
arm group type: Active Comparator
arm group label: direct restoration
arm group type: Active Comparator
intervention type: Procedure
intervention name: Coronal restoration
description: A restorative material like composite resin is condensed into the cavity of teeth.
arm group label: direct restoration
arm group label: indirect restoration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Okan University
investigator full name: Melek ÇAM
investigator title: Assist. Prof.
sharing ipd: Undecided