<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/NCT02200861</url>
  </required_header>
  <id_info>
    <org_study_id>2014/389</org_study_id>
    <nct_id>NCT02200861</nct_id>
  </id_info>
  <brief_title>Tooth Extraction With Deep Sedation in Children: A Retrospective Study</brief_title>
  <official_title>Tooth Extraction With Deep Sedation in Children: A Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TC Erciyes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts&#xD;
      were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep&#xD;
      sedation. All patients dates will evaluate from their patient file retrospectively from 2011&#xD;
      to 2014.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Majority of dental treatments can be performed under local anesthesia. However, this is not&#xD;
      always possible for pediatric non-cooperated patients with severe anxiety. In these patients,&#xD;
      unpleasant dental experiences may lead to development of dental phobia when they become&#xD;
      adults . Therefore, it is important to eradicate anxiety, and to prevent a possible&#xD;
      psychological trauma in pediatric patients. For this purpose, psychological and medical&#xD;
      methods have been applied to increase patient compliance. It has been proven that general&#xD;
      anesthesia especially prevents dental phobia in elderly, and increases the quality of life&#xD;
      related to oral health. In this study we aimed to evaluated the patients in whom dental local&#xD;
      anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth&#xD;
      extraction with deep sedation. All patients dates will evaluate from their patient file&#xD;
      retrospectively from 2011 to 2014.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>anesthetic technics used for deep sedation</measure>
    <time_frame>2 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects observed in patients</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">885</enrollment>
  <condition>Tooth Extraction Status Nos</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients who dental treatment was performed with deep sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patients who dental treatment was performed local anesthesia or general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erciyes University</name>
      <address>
        <city>Kayseri</city>
        <zip>38280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TC Erciyes University</investigator_affiliation>
    <investigator_full_name>Dilek Günay CANPOLAT</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>sedation,</keyword>
  <keyword>tooth extraction,</keyword>
  <!-- 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/NCT02200861
org study id: 2014/389
nct id: NCT02200861
lead sponsor: 
has dmc: No
In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts
      were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep
      sedation. All patients dates will evaluate from their patient file retrospectively from 2011
      to 2014.
Majority of dental treatments can be performed under local anesthesia. However, this is not
      always possible for pediatric non-cooperated patients with severe anxiety. In these patients,
      unpleasant dental experiences may lead to development of dental phobia when they become
      adults . Therefore, it is important to eradicate anxiety, and to prevent a possible
      psychological trauma in pediatric patients. For this purpose, psychological and medical
      methods have been applied to increase patient compliance. It has been proven that general
      anesthesia especially prevents dental phobia in elderly, and increases the quality of life
      related to oral health. In this study we aimed to evaluated the patients in whom dental local
      anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth
      extraction with deep sedation. All patients dates will evaluate from their patient file
      retrospectively from 2011 to 2014.
time perspective: Retrospective
measure: anesthetic technics used for deep sedation
time frame: 2 month
measure: side effects observed in patients
time frame: 2 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: TC Erciyes University
investigator full name: Dilek Günay CANPOLAT
investigator title: Associate Professor