<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/NCT01680848</url>
  </required_header>
  <id_info>
    <org_study_id>E1157</org_study_id>
    <nct_id>NCT01680848</nct_id>
  </id_info>
  <brief_title>Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan</brief_title>
  <official_title>Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dental PBRN Japan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dental Practice-Based Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dental PBRN Japan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for&#xD;
      diagnosis, treatment, and prevention of dental caries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used&#xD;
      the same questionnaire as used in the DPBRN Study, &quot;Assessment of Caries Diagnosis and Caries&#xD;
      Treatment&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Indicate Surgical Intervention</measure>
    <time_frame>Up to 24 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">282</enrollment>
  <condition>Dental Caries</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are dentists who work in outpatient dental practices who have affiliated with&#xD;
        Dental PBRN Japan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This study queried dentists working in outpatient dental practices who have affiliated&#xD;
             with JDPBRN to investigate research questions and to share experiences and expertise&#xD;
             (n = 282).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dentist who doesn't perform some measure of restorative dentistry at their practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naoki Kakudate, DDS PhD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyushu Dental University</affiliation>
  </overall_official>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>January 20, 2016</results_first_submitted>
  <results_first_submitted_qc>October 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 12, 2016</results_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dental caries,</keyword>
  <keyword>Caries diagnosis,</keyword>
  <keyword>Caries treatment,</keyword>
  <keyword>Caries risk,</keyword>
  <keyword>Practice pattern,</keyword>
  <keyword>Clinical epidemiology,</keyword>
  <keyword>Dental Practice-Based Research Network</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Currently, we have no plan.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>JDPBRN Dentists</title>
          <description>Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="282"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="189"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>JDPBRN Dentists</title>
          <description>Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.&#xD;
The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="189"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Participants were recruited from the JDPBRN Web site and mailings if they indicated that they perform some measure of restorative dentistry at their practice.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>The mean number of years elapsed since graduation from dental school</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.5" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Indicate Surgical Intervention</title>
        <time_frame>Up to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Caries Risk</title>
            <description>The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Indicate Surgical Intervention</title>
          <units>percentage of the dentists</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>This is an Observational Study</title>
          <description>This is an observational study. We don't have two arms.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of the Dental PBRN Japan</name_or_title>
      <organization>Dental PBRN Japan</organization>
      <phone>+81-93-285-3022</phone>
      <email>info@dentalpbrn.jp</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01680848
org study id: E1157
nct id: NCT01680848
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for
      diagnosis, treatment, and prevention of dental caries.
We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used
      the same questionnaire as used in the DPBRN Study, "Assessment of Caries Diagnosis and Caries
      Treatment".
observational model: Cohort
time perspective: Cross-Sectional
measure: Percentage of Participants Who Indicate Surgical Intervention
time frame: Up to 24 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Naoki Kakudate, DDS PhD MPH
role: Principal Investigator
affiliation: Kyushu Dental University
responsible party type: Sponsor
mesh term: Dental Caries
sharing ipd: No
ipd description: Currently, we have no plan.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 