xml: <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/NCT06017570</url>
    </required_header>
    <id_info>
      <org_study_id>SelcukU003</org_study_id>
      <nct_id>NCT06017570</nct_id>
    </id_info>
    <brief_title>Does the DMFT Score Affect the Distal Caries of the Second Molars Adjacent to the Mandibular Impacted Third Molars?</brief_title>
    <official_title>Does the DMFT Score Affect the Distal Caries of the Second Molars Adjacent to the Mandibular Impacted Third Molars? A Cross-sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk 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>
        Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and&#xD;
        external root resorption. The incidence of caries is high, especially in partially impacted&#xD;
        third molars in mesioangular and horizontal positions. In this study, investigators aimed to&#xD;
        examine the caries correlation in the distal second molar with the DMFT scores of the&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Radiologic examination</measure>
      <time_frame>10 minute before the start of surgery</time_frame>
      <description>Radiologic examination on the distal side of the second molar for tooth decay</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intra-oral examination</measure>
      <time_frame>10 minute before the start of surgery</time_frame>
      <description>Obtaining DMFT score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical examination</measure>
      <time_frame>1 minutes after the removal of third molar</time_frame>
      <description>Clinical examination (intra-oral) on the distal side of the second molar for tooth decay</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">639</enrollment>
    <condition>Decay, Dental</condition>
    <condition>Impacted Third Molar Tooth</condition>
    <arm_group>
      <arm_group_label>Low-risk Group</arm_group_label>
      <description>Participants with DMFT score: 0 or 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Modarate-risk Group</arm_group_label>
      <description>Participants with DMFT score: 2, 3, 4 or 5.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High-risk Group</arm_group_label>
      <description>Participants with DMFT score above 5.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Radiologic examination on orthopantomogram</intervention_name>
      <description>Caries examination on the distal side of the adjacent second molar in the orthopantomogram of patients with an appointment for the extraction of mesioangular or horizontal partially impacted third molars</description>
      <arm_group_label>High-risk Group</arm_group_label>
      <arm_group_label>Low-risk Group</arm_group_label>
      <arm_group_label>Modarate-risk Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Clinical examination after surgery</intervention_name>
      <description>İnspectional caries examination on the distal side of the adjacent second molar after surgery of patients with mesioangular or horizontal partially impacted third molars</description>
      <arm_group_label>High-risk Group</arm_group_label>
      <arm_group_label>Low-risk Group</arm_group_label>
      <arm_group_label>Modarate-risk Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients having surgery appointment was investigated for distal caries on the second&#xD;
          molar adjacent to the horizontal or mesioangular mandibular partially impacted third molar.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being between 20 and 40 years old&#xD;
  &#xD;
            -  having a surgery appointment for removal of the partially impacted third molar which&#xD;
               is mesioangular or horizontal position&#xD;
  &#xD;
            -  having an orthopantomogram on the database&#xD;
  &#xD;
            -  and having a second molar adjacent to the impacted third molar&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  crowned or restored the second molar&#xD;
  &#xD;
            -  any surgery related to the contact area&#xD;
  &#xD;
            -  any pathology related to the second or third molar&#xD;
  &#xD;
            -  a radiological artifact on the contact area&#xD;
  &#xD;
            -  insufficient radiological quality for the evaluation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Gokhan Gurses</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth, Impacted</mesh_term>
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017570
  org study id: SelcukU003
  nct id: NCT06017570
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and
        external root resorption. The incidence of caries is high, especially in partially impacted
        third molars in mesioangular and horizontal positions. In this study, investigators aimed to
        examine the caries correlation in the distal second molar with the DMFT scores of the
        participants.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Radiologic examination
  time frame: 10 minute before the start of surgery
  description: Radiologic examination on the distal side of the second molar for tooth decay
  measure: Intra-oral examination
  time frame: 10 minute before the start of surgery
  description: Obtaining DMFT score
  measure: Clinical examination
  time frame: 1 minutes after the removal of third molar
  description: Clinical examination (intra-oral) on the distal side of the second molar for tooth decay
  arm group label: Low-risk Group
  description: Participants with DMFT score: 0 or 1.
  arm group label: Modarate-risk Group
  description: Participants with DMFT score: 2, 3, 4 or 5.
  arm group label: High-risk Group
  description: Participants with DMFT score above 5.
  intervention type: Diagnostic Test
  intervention name: Radiologic examination on orthopantomogram
  description: Caries examination on the distal side of the adjacent second molar in the orthopantomogram of patients with an appointment for the extraction of mesioangular or horizontal partially impacted third molars
  arm group label: High-risk Group
  arm group label: Low-risk Group
  arm group label: Modarate-risk Group
  intervention type: Diagnostic Test
  intervention name: Clinical examination after surgery
  description: İnspectional caries examination on the distal side of the adjacent second molar after surgery of patients with mesioangular or horizontal partially impacted third molars
  arm group label: High-risk Group
  arm group label: Low-risk Group
  arm group label: Modarate-risk Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Gokhan Gurses
  investigator title: Assistant Professor
  mesh term: Tooth, Impacted
  mesh term: Dental Caries
  sharing ipd: Undecided