<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/NCT03304184</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00111890</org_study_id>
    <nct_id>NCT03304184</nct_id>
  </id_info>
  <brief_title>The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life</brief_title>
  <official_title>The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will compare two different dental materials on dental lesions near the gum line&#xD;
      that cause chronic pain on oral health related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will compare two different dental materials on dental lesions near the gum line.&#xD;
      One of the materials is tooth colored and the other material is white but both materials use&#xD;
      different mechanisms to attach to the teeth and may have different outcomes. The study will&#xD;
      determine if one material is more effective in relieving chronic pain. In addition, we will&#xD;
      evaluate changes in oral health related quality of life after the placement of the two&#xD;
      different dental materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">October 9, 2019</completion_date>
  <primary_completion_date type="Actual">October 9, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global Base Changes of Pain</measure>
    <time_frame>baseline, week1, week 2, 3 month follow up</time_frame>
    <description>A one survey description detailing the changes in pain over time based on the following scale:&#xD;
-No change (or condition has gotten worse)&#xD;
-Almost the same, hardly any change at all&#xD;
-A little better, but no noticeable change&#xD;
-Somewhat better, but the change has not made any real difference&#xD;
-Moderately better, and a slight but noticeable change&#xD;
-Better and a definite improvement that has made a real and worthwhile difference&#xD;
-A great deal better and a considerable improvement that has made all the difference</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life Using a Survey With 49 Questions</measure>
    <time_frame>Baseline, week1, week 2, 3 month follow up</time_frame>
    <description>A survey of 49 questions to assess oral health related quality of life. The scale measured 49 questions with a yes (1) or no (0) answers with a possible range of 0-49. The more answers of yes will indicate a higher score on the survey, which describes poorer oral health related quality of life. A lower number reflects better oral health related quality of life. A maximum score of 49 is the worst outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory</measure>
    <time_frame>Baseline, week1, week 2, 3 month follow up</time_frame>
    <description>6 questions were used to measure pain on a sliding scale from 1-100 at each time point. The scale ranged from 1 being no pain and 100 being extreme pain. The higher the number reflects worse the pain compared to a lower number. The maximum range from the participants was 600 (maximum) and the lowest range of 0 for all questions. The data reflects the averaged sum for each time point for all patients in each arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Quality of Life</condition>
  <condition>Cervical Abrasion</condition>
  <arm_group>
    <arm_group_label>Photac-fil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photac-fil</intervention_name>
    <description>Application of a tooth colored filling in a non-cavitated dental lesion.</description>
    <arm_group_label>Photac-fil</arm_group_label>
    <other_name>Resin modified glass ionomer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biodentine</intervention_name>
    <description>Application of a white colored filling in a non-cavitated dental lesion.</description>
    <arm_group_label>Biodentine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females age 18-64&#xD;
&#xD;
          -  Chief complaint associated with pain from cold or hot&#xD;
&#xD;
          -  Chronic sensitivity associated with supragingival lesions&#xD;
&#xD;
          -  Pain not associated with decay&#xD;
&#xD;
          -  Fluent in English and able to read English at a 6th grade level&#xD;
&#xD;
          -  Pulpal response &lt;40 via pulp tester&#xD;
&#xD;
          -  Active salivary flow from palpation of parotid and submandibular glands&#xD;
&#xD;
          -  Patients self reporting pain over 6/10 in the past week and/or the past 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients taking benzodiazepines, narcotics and multiple antidepressants for pain&#xD;
             management not associated with the oral cavity&#xD;
&#xD;
          -  Unexplained dry mouth&#xD;
&#xD;
          -  Patients taking two or more medications associated with dry mouth&#xD;
&#xD;
          -  Pulpal response &gt;40 via pulp tester&#xD;
&#xD;
          -  Patients requiring treatment for more than 5 decayed sites, periodontal disease and&#xD;
             root canal therapy&#xD;
&#xD;
          -  Complicated medical history (&gt;4 concurrent treatment for systemic diseases)&#xD;
&#xD;
          -  Lesion &gt;1mm below the gum line&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dental School</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>March 25, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2021</results_first_posted>
  <disposition_first_submitted>October 3, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 28, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 19, 2021</disposition_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Elizabeth Van Tubergen</investigator_full_name>
    <investigator_title>Clinical Assistant professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03304184/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03304184/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Photac-fil</title>
          <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
        </group>
        <group group_id="P2">
          <title>Biodentine</title>
          <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Photac-fil</title>
          <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
        </group>
        <group group_id="B2">
          <title>Biodentine</title>
          <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="24"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Global Base Changes of Pain</title>
        <description>A one survey description detailing the changes in pain over time based on the following scale:&#xD;
-No change (or condition has gotten worse)&#xD;
-Almost the same, hardly any change at all&#xD;
-A little better, but no noticeable change&#xD;
-Somewhat better, but the change has not made any real difference&#xD;
-Moderately better, and a slight but noticeable change&#xD;
-Better and a definite improvement that has made a real and worthwhile difference&#xD;
-A great deal better and a considerable improvement that has made all the difference</description>
        <time_frame>baseline, week1, week 2, 3 month follow up</time_frame>
        <population>Global Base Changes of pain measured over 3 months</population>
        <group_list>
          <group group_id="O1">
            <title>Photac-fil</title>
            <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
          </group>
          <group group_id="O2">
            <title>Biodentine</title>
            <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Base Changes of Pain</title>
          <description>A one survey description detailing the changes in pain over time based on the following scale:&#xD;
-No change (or condition has gotten worse)&#xD;
-Almost the same, hardly any change at all&#xD;
-A little better, but no noticeable change&#xD;
-Somewhat better, but the change has not made any real difference&#xD;
-Moderately better, and a slight but noticeable change&#xD;
-Better and a definite improvement that has made a real and worthwhile difference&#xD;
-A great deal better and a considerable improvement that has made all the difference</description>
          <population>Global Base Changes of pain measured over 3 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global base changes-baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.4"/>
                    <measurement group_id="O2" value="2.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global base changes-week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="1.6"/>
                    <measurement group_id="O2" value="4.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global base changes-week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread=".6"/>
                    <measurement group_id="O2" value="4.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global base changes-3 month follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread=".6"/>
                    <measurement group_id="O2" value="4.6" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)</non_inferiority_desc>
            <p_value>.0001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The estimation values were from an average of all values in each arm.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints</non_inferiority_desc>
            <p_value>.0005</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The estimation values were from an average of all values in each arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oral Health Related Quality of Life Using a Survey With 49 Questions</title>
        <description>A survey of 49 questions to assess oral health related quality of life. The scale measured 49 questions with a yes (1) or no (0) answers with a possible range of 0-49. The more answers of yes will indicate a higher score on the survey, which describes poorer oral health related quality of life. A lower number reflects better oral health related quality of life. A maximum score of 49 is the worst outcome.</description>
        <time_frame>Baseline, week1, week 2, 3 month follow up</time_frame>
        <population>OHIP-49 score for Photac group measured over 3 months</population>
        <group_list>
          <group group_id="O1">
            <title>Photac</title>
            <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
          </group>
          <group group_id="O2">
            <title>Biodentine</title>
            <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Health Related Quality of Life Using a Survey With 49 Questions</title>
          <description>A survey of 49 questions to assess oral health related quality of life. The scale measured 49 questions with a yes (1) or no (0) answers with a possible range of 0-49. The more answers of yes will indicate a higher score on the survey, which describes poorer oral health related quality of life. A lower number reflects better oral health related quality of life. A maximum score of 49 is the worst outcome.</description>
          <population>OHIP-49 score for Photac group measured over 3 months</population>
          <units>total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline measurement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="11.2"/>
                    <measurement group_id="O2" value="14.4" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 measurement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="8.1"/>
                    <measurement group_id="O2" value="12.7" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 measurement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="6.9"/>
                    <measurement group_id="O2" value="7.4" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="5.1"/>
                    <measurement group_id="O2" value="4.9" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).</non_inferiority_desc>
            <p_value>.0910</p_value>
            <p_value_desc>Comparison between two groups for treatment</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The estimation values were from an average of all values in each arm.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points</non_inferiority_desc>
            <p_value>.0262</p_value>
            <p_value_desc>Comparison between the two arms for treatment time points with analysis</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The estimation values were from an average of all values in each arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Brief Pain Inventory</title>
        <description>6 questions were used to measure pain on a sliding scale from 1-100 at each time point. The scale ranged from 1 being no pain and 100 being extreme pain. The higher the number reflects worse the pain compared to a lower number. The maximum range from the participants was 600 (maximum) and the lowest range of 0 for all questions. The data reflects the averaged sum for each time point for all patients in each arm.</description>
        <time_frame>Baseline, week1, week 2, 3 month follow up</time_frame>
        <population>Brief pain inventory measured over time</population>
        <group_list>
          <group group_id="O1">
            <title>Photac-fil</title>
            <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
          </group>
          <group group_id="O2">
            <title>Biodentine</title>
            <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory</title>
          <description>6 questions were used to measure pain on a sliding scale from 1-100 at each time point. The scale ranged from 1 being no pain and 100 being extreme pain. The higher the number reflects worse the pain compared to a lower number. The maximum range from the participants was 600 (maximum) and the lowest range of 0 for all questions. The data reflects the averaged sum for each time point for all patients in each arm.</description>
          <population>Brief pain inventory measured over time</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Brief pain inventory score- baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.4" spread="106.3"/>
                    <measurement group_id="O2" value="192.6" spread="169.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brief pain inventory score- week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.1" spread="122.8"/>
                    <measurement group_id="O2" value="141.1" spread="179.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brief pain inventory score- week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" spread="134.8"/>
                    <measurement group_id="O2" value="66.8" spread="71.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brief pain inventory score- 3 month recall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="96.4"/>
                    <measurement group_id="O2" value="76.8" spread="122.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.</non_inferiority_desc>
            <p_value>.0289</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The estimation values were from an average of all values in each arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over the first two weeks of the placement of Biodentine as the material debonded from the tooth.</time_frame>
      <desc>If any of the treatment arms have a deviation as a result of the restoration falling out or debonding, it is not a serious adverse event because the tooth was not prepped prior to the placement of the restoration. This would result in the area of the tooth that lost the restoration going back to the pre-treatment form. This would also not result in any risk of mortality.</desc>
      <group_list>
        <group group_id="E1">
          <title>Photac-fil</title>
          <description>Participants will have a restoration placed with photac-fil in the lesion near the gum line.&#xD;
Photac-fil: Application of a tooth colored filling in a non-cavitated dental lesion.</description>
        </group>
        <group group_id="E2">
          <title>Biodentine</title>
          <description>Participants will have a restoration placed with Biodentine in the lesion near the gum line.&#xD;
Biodentine: Application of a white colored filling in a non-cavitated dental lesion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="15"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Debonding of Biodentine from area added</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Elizabeth Van Tubergen</name_or_title>
      <organization>University of Michigan</organization>
      <phone>2487045640</phone>
      <email>evantub@umich.edu</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/NCT03304184
org study id: HUM00111890
nct id: NCT03304184
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study will compare two different dental materials on dental lesions near the gum line
      that cause chronic pain on oral health related quality of life.
The study will compare two different dental materials on dental lesions near the gum line.
      One of the materials is tooth colored and the other material is white but both materials use
      different mechanisms to attach to the teeth and may have different outcomes. The study will
      determine if one material is more effective in relieving chronic pain. In addition, we will
      evaluate changes in oral health related quality of life after the placement of the two
      different dental materials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.
primary purpose: Treatment
masking: None (Open Label)
measure: Global Base Changes of Pain
time frame: baseline, week1, week 2, 3 month follow up
description: A one survey description detailing the changes in pain over time based on the following scale:
-No change (or condition has gotten worse)
-Almost the same, hardly any change at all
-A little better, but no noticeable change
-Somewhat better, but the change has not made any real difference
-Moderately better, and a slight but noticeable change
-Better and a definite improvement that has made a real and worthwhile difference
-A great deal better and a considerable improvement that has made all the difference
measure: Oral Health Related Quality of Life Using a Survey With 49 Questions
time frame: Baseline, week1, week 2, 3 month follow up
description: A survey of 49 questions to assess oral health related quality of life. The scale measured 49 questions with a yes (1) or no (0) answers with a possible range of 0-49. The more answers of yes will indicate a higher score on the survey, which describes poorer oral health related quality of life. A lower number reflects better oral health related quality of life. A maximum score of 49 is the worst outcome.
measure: Brief Pain Inventory
time frame: Baseline, week1, week 2, 3 month follow up
description: 6 questions were used to measure pain on a sliding scale from 1-100 at each time point. The scale ranged from 1 being no pain and 100 being extreme pain. The higher the number reflects worse the pain compared to a lower number. The maximum range from the participants was 600 (maximum) and the lowest range of 0 for all questions. The data reflects the averaged sum for each time point for all patients in each arm.
arm group label: Photac-fil
arm group type: Placebo Comparator
description: Participants will have a restoration placed with photac-fil in the lesion near the gum line.
arm group label: Biodentine
arm group type: Experimental
description: Participants will have a restoration placed with Biodentine in the lesion near the gum line.
intervention type: Device
intervention name: Photac-fil
description: Application of a tooth colored filling in a non-cavitated dental lesion.
arm group label: Photac-fil
other name: Resin modified glass ionomer
intervention type: Device
intervention name: Biodentine
description: Application of a white colored filling in a non-cavitated dental lesion.
arm group label: Biodentine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Elizabeth Van Tubergen
investigator title: Clinical Assistant professor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 