<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/NCT03230604</url>
  </required_header>
  <id_info>
    <org_study_id>DI-1301-16/CB</org_study_id>
    <nct_id>NCT03230604</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations</brief_title>
  <official_title>Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional Andres Bello</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional Andres Bello</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To minimize the effects of polymerization shrinkage in the restorative treatment, there are&#xD;
      new composites called Bulk- Fill which the companies has developed this composites for&#xD;
      example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization&#xD;
      shrinkage and properties allow the material to be inserted in one layer being quickly than&#xD;
      traditional composite. This clinical study is designed to compare the clinical performance of&#xD;
      the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior)&#xD;
      and V (cervical-surface posterior) fillings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A patients with 3 caries lesions class one either two or five will be divided into 3 groups ,&#xD;
      cavities will be incrementally layered with resin composite and each increment will be cured&#xD;
      as directed by the manufacturer with the light curing unit (Bluephase Style&#xD;
      Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will&#xD;
      be restored by bulk fill composite (3M ESPE) and other bulk fill composite (&#xD;
      IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with&#xD;
      the light curing unit.&#xD;
&#xD;
      The study will investigate the clinical performance and efficacy of a bulk-filled composite&#xD;
      resin restorative material for a period of 5 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 24, 2017</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>
    <intervention_model_description>Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities&#xD;
Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance restoration</measure>
    <time_frame>six month, one years, two, three, four and five years</time_frame>
    <description>Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Post Dental Restoration</condition>
  <condition>Caries, Dental</condition>
  <arm_group>
    <arm_group_label>Bulk-Fill composite Class I, II and V cavities</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Z 350 xt Composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Restorative with Z 350 xt composite in class I, II and V</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite</intervention_name>
    <description>Restorative cavities one, two and five with material Filtek Bulk Fill Composite</description>
    <arm_group_label>Bulk-Fill composite Class I, II and V cavities</arm_group_label>
    <arm_group_label>Z 350 xt Composite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Z 350 Xt Composite</intervention_name>
    <description>Restorative cavities one, two and five with material Z 350 XT Composite</description>
    <arm_group_label>Bulk-Fill composite Class I, II and V cavities</arm_group_label>
    <arm_group_label>Z 350 xt Composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must have given written informed consent to participate in the trial&#xD;
&#xD;
          -  need at least three posterior restorations&#xD;
&#xD;
          -  must be available for the required post-operative follow-up visits&#xD;
&#xD;
          -  have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to&#xD;
             lingual/palatal cusp tips&#xD;
&#xD;
          -  At least one occlusal and proximal contact on a natural tooth&#xD;
&#xD;
          -  Cavities depth &gt; 2 mm in cervico-occlusal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have severe medical complications (organ transplants, long term antibiotic or steroid&#xD;
             treatment, cancer or immunocompromised) and disabilities who may not be able to&#xD;
             tolerate the time required to complete the restorations&#xD;
&#xD;
          -  have xerostomia either by taking medications known to produce xerostomia or those with&#xD;
             radiation induced or Sjogren's syndrome patients&#xD;
&#xD;
          -  chronic periodontitis&#xD;
&#xD;
          -  present with any systemic or local disorders that contra-indicate the dental&#xD;
             procedures included in this study&#xD;
&#xD;
          -  an unstable occlusion&#xD;
&#xD;
          -  severe bruxing&#xD;
&#xD;
          -  teeth with periapical pathology or expected pulp exposures&#xD;
&#xD;
          -  are pregnant.&#xD;
&#xD;
          -  Endodontically treated teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Odontologia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Andres Bello</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patricio Vildosola Grez</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>7510583</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional Andres Bello</investigator_affiliation>
    <investigator_full_name>Patricio Vildosola Grez</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>Z 350</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03230604
org study id: DI-1301-16/CB
nct id: NCT03230604
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To minimize the effects of polymerization shrinkage in the restorative treatment, there are
      new composites called Bulk- Fill which the companies has developed this composites for
      example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization
      shrinkage and properties allow the material to be inserted in one layer being quickly than
      traditional composite. This clinical study is designed to compare the clinical performance of
      the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior)
      and V (cervical-surface posterior) fillings.
A patients with 3 caries lesions class one either two or five will be divided into 3 groups ,
      cavities will be incrementally layered with resin composite and each increment will be cured
      as directed by the manufacturer with the light curing unit (Bluephase Style
      Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will
      be restored by bulk fill composite (3M ESPE) and other bulk fill composite (
      IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with
      the light curing unit.

      The study will investigate the clinical performance and efficacy of a bulk-filled composite
      resin restorative material for a period of 5 years
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities
Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical performance restoration
time frame: six month, one years, two, three, four and five years
description: Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.
arm group label: Bulk-Fill composite Class I, II and V cavities
arm group type: Active Comparator
description: Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V
arm group label: Z 350 xt Composite
arm group type: Active Comparator
description: Restorative with Z 350 xt composite in class I, II and V
intervention type: Device
intervention name: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite
description: Restorative cavities one, two and five with material Filtek Bulk Fill Composite
arm group label: Bulk-Fill composite Class I, II and V cavities
arm group label: Z 350 xt Composite
intervention type: Device
intervention name: Z 350 Xt Composite
description: Restorative cavities one, two and five with material Z 350 XT Composite
arm group label: Bulk-Fill composite Class I, II and V cavities
arm group label: Z 350 xt Composite
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Odontologia
role: Principal Investigator
affiliation: Universidad Andres Bello
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional Andres Bello
investigator full name: Patricio Vildosola Grez
investigator title: Associate Professor
mesh term: Dental Caries
mesh term: Z 350