<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/NCT03032705</url>
  </required_header>
  <id_info>
    <org_study_id>12311</org_study_id>
    <nct_id>NCT03032705</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative</brief_title>
  <official_title>Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kavo Kerr Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare esthetic, functional and biological properties of two&#xD;
      restoration materials used to fill cavities. One material is called &quot;Filtek™ Supreme&quot; which&#xD;
      is a traditional tooth colored resin composite that is placed in the cavity in layers and&#xD;
      hardened with UV light. The second material is called &quot;SonicFill™ 2,&quot; which is a bulk fill&#xD;
      composite that uses an ultrasonic hand piece to change the material from a solid into a&#xD;
      liquid in order to place it into the cavity. This material can be placed in the cavity in 1&#xD;
      layer, and is hardened using UV light. Both materials have been FDA approved as&#xD;
      non-significant risk devices for filling cavities.&#xD;
&#xD;
      In each subject, one tooth with a cavity will be randomly selected to receive one filling&#xD;
      material, and a second tooth with a cavity will be randomly selected to receive the second&#xD;
      material. The fillings will be observed over a two year period to determine clinical&#xD;
      acceptability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of&#xD;
      Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to&#xD;
      Filtek™ Supreme resin composite placed in the traditional incremental technique.&#xD;
&#xD;
      The primary objective of this study is to evaluate the clinical performance of a&#xD;
      sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the&#xD;
      following categories:&#xD;
&#xD;
      Esthetic Properties&#xD;
&#xD;
        -  Surface luster&#xD;
&#xD;
        -  Staining - surface&#xD;
&#xD;
        -  Staining - margin&#xD;
&#xD;
        -  Color match and translucency&#xD;
&#xD;
        -  Esthetic anatomical form&#xD;
&#xD;
      Functional Properties&#xD;
&#xD;
        -  Fracture of material and retention&#xD;
&#xD;
        -  Marginal adaptation&#xD;
&#xD;
        -  Approximate anatomical form - contact point&#xD;
&#xD;
        -  Radio-graphic examination (when applicable)&#xD;
&#xD;
        -  Patient's view&#xD;
&#xD;
      Biological Properties&#xD;
&#xD;
        -  Postoperative (hyper-)sensitivity and tooth vitality&#xD;
&#xD;
        -  Recurrence of caries, erosion, abfraction&#xD;
&#xD;
        -  Tooth integrity (enamel cracks, tooth fractures)&#xD;
&#xD;
        -  Adjacent mucosa&#xD;
&#xD;
      The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2,&#xD;
      will have comparable results to the traditional incremental technique composite, Filtek™&#xD;
      Supreme, in overall clinical acceptability and in all compared categories&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category</measure>
    <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
    <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Surface luster&#xD;
Staining - surface&#xD;
Staining - margin&#xD;
Color match and translucency&#xD;
Esthetic anatomical form&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category</measure>
    <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
    <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Fracture of material and retention&#xD;
Marginal adaptation&#xD;
Approximate anatomical form - contact point&#xD;
Radio-graphic examination (when applicable)&#xD;
Patient's view&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category</measure>
    <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
    <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Postoperative (hyper-)sensitivity and tooth vitality&#xD;
Recurrence of caries, erosion, abfraction&#xD;
Tooth integrity (enamel cracks, tooth fractures)&#xD;
Adjacent mucosa&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>SonicFill™ 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Filtek™ Supreme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SonicFill™ 2</intervention_name>
    <description>The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
    <arm_group_label>SonicFill™ 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek™ Supreme</intervention_name>
    <description>The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</description>
    <arm_group_label>Filtek™ Supreme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is at least 18 years of age&#xD;
&#xD;
          -  Is willing to provide voluntary written informed consent&#xD;
&#xD;
          -  Is in good medical health and able to tolerate the dental procedures&#xD;
&#xD;
          -  Has at least 1 pair of qualifying molars or premolars that require Class II&#xD;
             restorations.&#xD;
&#xD;
          -  Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3&#xD;
             the distance from buccal to lingual/palatal cusp tips&#xD;
&#xD;
          -  Study teeth must be in occlusal function and must also be in contact with the&#xD;
             neighboring tooth on at least one surface&#xD;
&#xD;
          -  Study teeth must be vital (i.e., free of clinical signs and symptoms of periapical&#xD;
             pathology)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently taking part in an evaluation of other dental restorative materials&#xD;
&#xD;
          -  Has chronic periodontitis or rampant caries&#xD;
&#xD;
          -  Teeth exhibiting clinical signs of periapical pathology&#xD;
&#xD;
          -  Teeth with a history of self-reported preoperative pulpal problems&#xD;
&#xD;
          -  Women who are pregnant (self-reported). It is standard of care to post-pone routine&#xD;
             dental procedures and radiographed until after pregnancy.&#xD;
&#xD;
          -  Women who are breast feeding.&#xD;
&#xD;
          -  Known allergy to resin composites or local anesthetics.&#xD;
&#xD;
          -  Abnormal oral soft tissue findings (e.g., open sores, lesions)&#xD;
&#xD;
          -  An employee of the sponsor or members of their immediate family.&#xD;
&#xD;
          -  Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)&#xD;
&#xD;
          -  Any restorative treatment of the teeth involved in the study in the last 12 months.&#xD;
&#xD;
          -  Are unwilling or unable to have dental radiographs or photographs taken of their&#xD;
             dentition and soft tissues&#xD;
&#xD;
          -  Any other condition which is the view of the investigator may affect the ability of a&#xD;
             patient to complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard Kugel, DMD, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TUSDM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts University School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>May 20, 2021</results_first_submitted>
  <results_first_submitted_qc>October 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2021</results_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Dr. Gerard Kugel</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Restorations</keyword>
  <keyword>Composite</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>
  </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>November 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03032705/Prot_SAP_000.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>September 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03032705/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Unit = Teeth. 51 participants were randomized in this study, and a total of 102 teeth were studied. Therefore 51 participants and 102 units.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>SonicFill™ 2</title>
          <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
        </group>
        <group group_id="P2">
          <title>Filtek™ Supreme</title>
          <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
                <participants group_id="P2" count="51">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completion of Restorations (V2)</title>
              <participants_list>
                <participants group_id="P1" count="45">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
                <participants group_id="P2" count="45">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
                <participants group_id="P2" count="28">Number of participants are same (repeated) for both groups&#xD;
unit = teeth</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not quality</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Each participants contributed 2 randomly selected teeth for each study group therefore 1 participant contributing 2 study teeth in each case. Therefore total number of participants is 45 and total number of units is 90.</population>
      <group_list>
        <group group_id="B1">
          <title>SonicFill™ 2</title>
          <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
        </group>
        <group group_id="B2">
          <title>Filtek™ Supreme</title>
          <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</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="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>teeth</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <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="43"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.13" spread="1.92"/>
                    <measurement group_id="B2" value="44.13" spread="1.92"/>
                    <measurement group_id="B3" value="44.13" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category</title>
        <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Surface luster&#xD;
Staining - surface&#xD;
Staining - margin&#xD;
Color match and translucency&#xD;
Esthetic anatomical form&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
        <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
        <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
        <group_list>
          <group group_id="O1">
            <title>SonicFill™ 2</title>
            <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
          </group>
          <group group_id="O2">
            <title>Filtek™ Supreme</title>
            <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category</title>
          <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Surface luster&#xD;
Staining - surface&#xD;
Staining - margin&#xD;
Color match and translucency&#xD;
Esthetic anatomical form&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
          <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
          <units>Teeth</units>
          <param>Count of Units</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Surface Luster at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Luster at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Luster at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Luster at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Luster at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Staining at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Staining at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Staining at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Staining at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surface Staining at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Staining at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Staining at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Staining at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Staining at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Staining at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Color Match and Translucency at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Color Match and Translucency at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Color Match and Translucency at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Color Match and Translucency at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Color Match and Translucency at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esthetic Anatomical Form at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esthetic Anatomical Form at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esthetic Anatomical Form at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esthetic Anatomical Form at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esthetic Anatomical Form at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category</title>
        <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Fracture of material and retention&#xD;
Marginal adaptation&#xD;
Approximate anatomical form - contact point&#xD;
Radio-graphic examination (when applicable)&#xD;
Patient's view&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
        <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
        <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
        <group_list>
          <group group_id="O1">
            <title>SonicFill™ 2</title>
            <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
          </group>
          <group group_id="O2">
            <title>Filtek™ Supreme</title>
            <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category</title>
          <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Fracture of material and retention&#xD;
Marginal adaptation&#xD;
Approximate anatomical form - contact point&#xD;
Radio-graphic examination (when applicable)&#xD;
Patient's view&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
          <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
          <units>Teeth</units>
          <param>Count of Units</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fracture of Material and Retention at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fracture of Material and Retention at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fracture of Material and Retention at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fracture of Material and Retention at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fracture of Material and Retention at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Adaptation at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Adaptation at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Adaptation at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Adaptation at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Adaptation at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiographic Examination at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiographic Examination at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiographic Examination at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiographic Examination at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiographic Examination at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient's View at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient's View at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient's View at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient's View at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient's View at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category</title>
        <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Postoperative (hyper-)sensitivity and tooth vitality&#xD;
Recurrence of caries, erosion, abfraction&#xD;
Tooth integrity (enamel cracks, tooth fractures)&#xD;
Adjacent mucosa&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
        <time_frame>From Baseline up to 2 Years After Restoration Placement</time_frame>
        <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
        <group_list>
          <group group_id="O1">
            <title>SonicFill™ 2</title>
            <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
          </group>
          <group group_id="O2">
            <title>Filtek™ Supreme</title>
            <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category</title>
          <description>The following properties will be evaluated using the Hickel Grading Criteria:&#xD;
Postoperative (hyper-)sensitivity and tooth vitality&#xD;
Recurrence of caries, erosion, abfraction&#xD;
Tooth integrity (enamel cracks, tooth fractures)&#xD;
Adjacent mucosa&#xD;
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable</description>
          <population>45 Participants, each with 2 &quot;units&quot; (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).</population>
          <units>Teeth</units>
          <param>Count of Units</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tooth Integrity at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tooth Integrity at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tooth Integrity at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tooth Integrity at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tooth Integrity at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjacent Mucosa at end of study : Number of teeth rated 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjacent Mucosa at end of study : Number of teeth rated 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjacent Mucosa at end of study : Number of teeth rated 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjacent Mucosa at end of study : Number of teeth rated 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjacent Mucosa at end of study : Number of teeth rated 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Teeth</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 24 months.</time_frame>
      <desc>Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.</desc>
      <group_list>
        <group group_id="E1">
          <title>SonicFill™ 2</title>
          <description>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT&#xD;
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.</description>
        </group>
        <group group_id="E2">
          <title>Filtek™ Supreme</title>
          <description>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive&#xD;
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.</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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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="14" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pulp exposure risk, healing of non- study site, Alterantion of study site due to non-study site tx</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post operative sensitivity/Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Fracture of restorations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Soft tissue irritation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
              </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>Dr Gerard Kugel</name_or_title>
      <organization>Tufts University School of Dental Medicine</organization>
      <phone>(617) 636-0870</phone>
      <email>Gerard.Kugel@tufts.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/NCT03032705
org study id: 12311
nct id: NCT03032705
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to compare esthetic, functional and biological properties of two
      restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which
      is a traditional tooth colored resin composite that is placed in the cavity in layers and
      hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill
      composite that uses an ultrasonic hand piece to change the material from a solid into a
      liquid in order to place it into the cavity. This material can be placed in the cavity in 1
      layer, and is hardened using UV light. Both materials have been FDA approved as
      non-significant risk devices for filling cavities.

      In each subject, one tooth with a cavity will be randomly selected to receive one filling
      material, and a second tooth with a cavity will be randomly selected to receive the second
      material. The fillings will be observed over a two year period to determine clinical
      acceptability.
This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of
      Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to
      Filtek™ Supreme resin composite placed in the traditional incremental technique.

      The primary objective of this study is to evaluate the clinical performance of a
      sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the
      following categories:

      Esthetic Properties

        -  Surface luster

        -  Staining - surface

        -  Staining - margin

        -  Color match and translucency

        -  Esthetic anatomical form

      Functional Properties

        -  Fracture of material and retention

        -  Marginal adaptation

        -  Approximate anatomical form - contact point

        -  Radio-graphic examination (when applicable)

        -  Patient's view

      Biological Properties

        -  Postoperative (hyper-)sensitivity and tooth vitality

        -  Recurrence of caries, erosion, abfraction

        -  Tooth integrity (enamel cracks, tooth fractures)

        -  Adjacent mucosa

      The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2,
      will have comparable results to the traditional incremental technique composite, Filtek™
      Supreme, in overall clinical acceptability and in all compared categories
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
time frame: From Baseline up to 2 Years After Restoration Placement
description: The following properties will be evaluated using the Hickel Grading Criteria:
Surface luster
Staining - surface
Staining - margin
Color match and translucency
Esthetic anatomical form
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
measure: Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
time frame: From Baseline up to 2 Years After Restoration Placement
description: The following properties will be evaluated using the Hickel Grading Criteria:
Fracture of material and retention
Marginal adaptation
Approximate anatomical form - contact point
Radio-graphic examination (when applicable)
Patient's view
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
measure: Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
time frame: From Baseline up to 2 Years After Restoration Placement
description: The following properties will be evaluated using the Hickel Grading Criteria:
Postoperative (hyper-)sensitivity and tooth vitality
Recurrence of caries, erosion, abfraction
Tooth integrity (enamel cracks, tooth fractures)
Adjacent mucosa
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
arm group label: SonicFill™ 2
arm group type: Experimental
description: Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
arm group label: Filtek™ Supreme
arm group type: Active Comparator
description: Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
intervention type: Device
intervention name: SonicFill™ 2
description: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
arm group label: SonicFill™ 2
intervention type: Device
intervention name: Filtek™ Supreme
description: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
arm group label: Filtek™ Supreme
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gerard Kugel, DMD, MS, PhD
role: Principal Investigator
affiliation: TUSDM
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Dr. Gerard Kugel
investigator title: Professor
mesh term: Dental Caries
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 