<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/NCT03764059</url>
  </required_header>
  <id_info>
    <org_study_id>MDI0102</org_study_id>
    <nct_id>NCT03764059</nct_id>
  </id_info>
  <brief_title>Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations</brief_title>
  <official_title>A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness&#xD;
      of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and&#xD;
      II dental cavities in posterior teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical&#xD;
      performance of resin composite, Filtek™ Bulk Fill.&#xD;
&#xD;
      Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for&#xD;
      Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market&#xD;
      for 5 years with some validated clinical data.&#xD;
&#xD;
      Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into&#xD;
      the study and were randomly assigned to the test group and the control group according to the&#xD;
      ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240&#xD;
      subjects were randomly enrolled in the study, including 120 subjects in the test group and&#xD;
      120 subjects in the control group, which met the required sample size.&#xD;
&#xD;
      The study consisted of screening period (initial screening visit, post-preparation screening&#xD;
      visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests&#xD;
      required in the protocol would be conducted to select the subjects meeting the criteria for&#xD;
      inclusion. The examination and evaluation of the initial screening period were supposed to be&#xD;
      completed within 0.5 days. Then investigators would make an appointment with the subjects&#xD;
      eligible for the initial screening for cavity preparation and tooth filling, the required&#xD;
      time of which depended on the complexity of the tooth problem and would be completed within&#xD;
      0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were&#xD;
      selected and qualified after preparation and patients with qualified score would continue to&#xD;
      have the 1-week and 1-year follow-up visits.&#xD;
&#xD;
      Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior&#xD;
      Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the&#xD;
      corresponding test product or control product to fill and restore posterior teeth defects&#xD;
      (class I or class II cavities).&#xD;
&#xD;
      Since all investigators were required to operate according to instructions, it was clear to&#xD;
      them which product a subject was given. However, subjects and clinical evaluators were&#xD;
      blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the&#xD;
      control product (Filtek™ Z350XT) was used by the subjects.&#xD;
&#xD;
      Immediately after restoration placement, at 1 week and 1 year postoperative, two or three&#xD;
      clinical evaluators from each site performed the clinical assessment (the third more senior&#xD;
      evaluator performed the assessment and determination if the first two evaluators were not in&#xD;
      agreement) per China Technical Instruction and Guidance of Resin Composite Restoration&#xD;
      Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical&#xD;
      acceptable rate of the restoration at 1 year was the primary endpoint in this study.&#xD;
&#xD;
      AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment&#xD;
      result, if the clinical acceptance rate of the two groups achieved the clinical acceptable&#xD;
      rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1&#xD;
      and II restorations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">November 14, 2019</completion_date>
  <primary_completion_date type="Actual">November 14, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Acceptance Rate of Restoration at 1 Year After Replacement</measure>
    <time_frame>1 Year after restoration</time_frame>
    <description>According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Dental Caries Class I</condition>
  <condition>Dental Caries Class II</condition>
  <arm_group>
    <arm_group_label>Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control device/control group: Filtek™ Z350XT Universal Restorative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek™ Bulk Fill Posterior Restorative</intervention_name>
    <description>The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.</description>
    <arm_group_label>Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek™ Z350XT Universal Restorative</intervention_name>
    <description>The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.</description>
    <arm_group_label>Control device/control group: Filtek™ Z350XT Universal Restorative</arm_group_label>
    <other_name>Filtek™ Supreme Ultra Universal Restorative</other_name>
    <other_name>Filtek™ Supreme XTE Universal Restorative</other_name>
    <other_name>Filtek™ Ultimate Universal Restorative</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female,18 to 70 years old (including 18 and 70 years)&#xD;
&#xD;
          2. Good health, no significant systemic disease;&#xD;
&#xD;
          3. Normal opening degree;&#xD;
&#xD;
          4. Molar (preferred) or premolar teeth&#xD;
&#xD;
          5. Cavity type with belongs to any of the following： 1) Class I, including the failed&#xD;
             class I restoration which require to be repaired.; 2) Class II, including premolar and&#xD;
             molar except the second molar (the failed class II restoration which require to be&#xD;
             repaired is also included), and the gingival wall of cavity is above the free gingival&#xD;
             margin coronally; 3) Class II cavity on the second molar when the third molar exists,&#xD;
             and the gingival wall of cavity is above the free gingival margin coronally; 4) Class&#xD;
             II, MO or MOD cavity on the second molar when the third molar does not exist (the&#xD;
             failed class II restoration which require to be repaired is also included), and the&#xD;
             gingival wall of cavity is above the free gingival margin coronally;&#xD;
&#xD;
          6. Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the&#xD;
             buccolingual cusp distance;&#xD;
&#xD;
          7. Occlusion with natural teeth;&#xD;
&#xD;
          8. Cavity depth: no less than 1/2 of dentin with a normal pulp status;&#xD;
&#xD;
          9. Be able to understand informed consent and to provide written inform consent ;&#xD;
&#xD;
         10. Be in good compliance with the protocol and willing to return to the site for follow&#xD;
             up visits .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to multiple medicines; allergy to resin or other polymer material;&#xD;
&#xD;
          2. Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder&#xD;
             of TMJ (temporomandibular joint);&#xD;
&#xD;
          3. Poor oral hygiene, DMTF:18-34y &gt;4, 35-70y &gt;5;&#xD;
&#xD;
          4. Teeth with abnormal staining ;&#xD;
&#xD;
          5. Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and&#xD;
             other non-caries diseases.&#xD;
&#xD;
          6. Abnormal occlusion;&#xD;
&#xD;
          7. Severe systemic or mental disorders;&#xD;
&#xD;
          8. Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding&#xD;
             women;&#xD;
&#xD;
          9. Cavity do not meet the criteria based on the investigator's judgement;&#xD;
&#xD;
         10. Resin Composite is not an appropriate restoration for the subject&#xD;
&#xD;
         11. Pulp exposure or bottom of cavity is nearly close to the pulp;&#xD;
&#xD;
         12. Subjects who is not able to return for the one year follow-up visit because of going&#xD;
             abroad or other reasons;&#xD;
&#xD;
         13. Subject is enrolled in other studies on investigational drug or device&#xD;
&#xD;
         14. Cannot tolerate rubber dam isolation. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoyan Wang, Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>Endodontics department of Peking University hospital of stomatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Stomatology Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Hospital of Stomatology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Stomatology Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>May 22, 2023</results_first_submitted>
  <results_first_submitted_qc>July 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2023</results_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dental restorative</keyword>
  <keyword>Composite posterior restorative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03764059/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03764059/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative</title>
          <description>The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
        </group>
        <group group_id="P2">
          <title>Control Device/Control Group: Filtek™ Z350XT Universal Restorative</title>
          <description>The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Interventional</title>
          <description>The experimental group (Filtek Bulk fill posterior restoration) .After restoration,subjects will return to site for follow up visit at 1 week and 1 year postoperative for further clinical assessments.&#xD;
Filtek bulk fill posterior restoration: The subjects will be assigned to either the investigational product (Filtek Bulk ) or the control product (Z350XT) per web-based randomization system.&#xD;
Immediately after restoration placement, at 1 week and 1 year postoperative, two evaluators from each site will perform an independent clinical assessment.</description>
        </group>
        <group group_id="B2">
          <title>Observational</title>
          <description>The control group (Filtek™ Z350XT Universal Restorative which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data).After restoration,subjects will return to the site for follow up visits at 1 week and 1 year postoperative for for further clinical assessments.&#xD;
Filtek™ Z350XT Universal Restorative: Filtek™ Z350XT Universal Restorative (Z350 XT) will serve as the control in this study.</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="120"/>
            <count group_id="B2" value="120"/>
            <count group_id="B3" value="240"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="120"/>
                    <count group_id="B3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.97" spread="6.65"/>
                    <measurement group_id="B2" value="28.12" spread="7.76"/>
                    <measurement group_id="B3" value="28.05" spread="10.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="120"/>
                    <count group_id="B3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical diagnosis of caries</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="120"/>
                    <count group_id="B3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Acceptance Rate of Restoration at 1 Year After Replacement</title>
        <description>According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.</description>
        <time_frame>1 Year after restoration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative</title>
            <description>The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
          </group>
          <group group_id="O2">
            <title>Control Device/Control Group: Filtek™ Z350XT Universal Restorative</title>
            <description>The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Acceptance Rate of Restoration at 1 Year After Replacement</title>
          <description>According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Acceptable restoration</title>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unacceptable restoration</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be &gt; -7%</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>- 0.6</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative</title>
          <description>The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</description>
        </group>
        <group group_id="E2">
          <title>Control Device/Control Group: Filtek™ Z350XT Universal Restorative</title>
          <description>The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.&#xD;
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.</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="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="45" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Non-target caries</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Post-operative tooth sensitivity</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Impacted wisdom teeth</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Wisdom tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Irregular dentition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Tooth sensitivity during operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Chronic periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Chronic periapical periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Plaque-induced gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Gum bleeding on the target side</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Gum pain on the target side</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Mild redness and swelling of gingival margin on the target side</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pain of buccal mucosa of target teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Mucosal ulceration of target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Radiolucent area of root tip of target teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Malaise of occlusion of target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Spontaneous discomfort of target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Edge caries of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Non-target residual root</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pericoronitis of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Secondary Caries of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Secondary Caries of non-target teeth (after endodontic treatment)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Reversible pulpitis of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Chronic pulpitis of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Non-target caries, gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Sensitivity of non-target teeth after operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Microdontia of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Wedge-shaped defect of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pulpitis of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Dental defect of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Gingival ulcer of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Mild redness and swelling of gingival margin of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Recurrent oral ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Generalized chronic periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pain in the injection point of buccal anesthetics</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Redness and swelling of gingiva near middle palatal side</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Gingival edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute attack of chronic pulpitis of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Acute laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gingival margin of palatine side injured by rubber dam</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Right ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Falling of filling material of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Coughing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Chestnut eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Treatment of non-target teeth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Other Treatments</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Xiaoyan Wang</name_or_title>
      <organization>Peking University Hospital of Stomatology</organization>
      <phone>010-82195525</phone>
      <email>wangxiaoyanpx@163.com</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/NCT03764059
org study id: MDI0102
nct id: NCT03764059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness
      of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and
      II dental cavities in posterior teeth.
This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical
      performance of resin composite, Filtek™ Bulk Fill.

      Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for
      Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market
      for 5 years with some validated clinical data.

      Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into
      the study and were randomly assigned to the test group and the control group according to the
      ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240
      subjects were randomly enrolled in the study, including 120 subjects in the test group and
      120 subjects in the control group, which met the required sample size.

      The study consisted of screening period (initial screening visit, post-preparation screening
      visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests
      required in the protocol would be conducted to select the subjects meeting the criteria for
      inclusion. The examination and evaluation of the initial screening period were supposed to be
      completed within 0.5 days. Then investigators would make an appointment with the subjects
      eligible for the initial screening for cavity preparation and tooth filling, the required
      time of which depended on the complexity of the tooth problem and would be completed within
      0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were
      selected and qualified after preparation and patients with qualified score would continue to
      have the 1-week and 1-year follow-up visits.

      Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior
      Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the
      corresponding test product or control product to fill and restore posterior teeth defects
      (class I or class II cavities).

      Since all investigators were required to operate according to instructions, it was clear to
      them which product a subject was given. However, subjects and clinical evaluators were
      blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the
      control product (Filtek™ Z350XT) was used by the subjects.

      Immediately after restoration placement, at 1 week and 1 year postoperative, two or three
      clinical evaluators from each site performed the clinical assessment (the third more senior
      evaluator performed the assessment and determination if the first two evaluators were not in
      agreement) per China Technical Instruction and Guidance of Resin Composite Restoration
      Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical
      acceptable rate of the restoration at 1 year was the primary endpoint in this study.

      AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment
      result, if the clinical acceptance rate of the two groups achieved the clinical acceptable
      rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1
      and II restorations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Clinical Acceptance Rate of Restoration at 1 Year After Replacement
time frame: 1 Year after restoration
description: According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
arm group label: Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative
arm group type: Experimental
description: The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
arm group label: Control device/control group: Filtek™ Z350XT Universal Restorative
arm group type: Active Comparator
description: The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality.
Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
intervention type: Device
intervention name: Filtek™ Bulk Fill Posterior Restorative
description: The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.
arm group label: Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative
intervention type: Device
intervention name: Filtek™ Z350XT Universal Restorative
description: The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.
arm group label: Control device/control group: Filtek™ Z350XT Universal Restorative
other name: Filtek™ Supreme Ultra Universal Restorative
other name: Filtek™ Supreme XTE Universal Restorative
other name: Filtek™ Ultimate Universal Restorative
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaoyan Wang, Director
role: Principal Investigator
affiliation: Endodontics department of Peking University hospital of stomatology
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Dental Caries
mesh term: Chlorhexidine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 