<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/NCT04481087</url>
  </required_header>
  <id_info>
    <org_study_id>NCCLs universal</org_study_id>
    <nct_id>NCT04481087</nct_id>
  </id_info>
  <brief_title>Clinical Comparison of Different Adhesives in NCCLs</brief_title>
  <official_title>Clinical Comparison of Different Adhesives in NCCLs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this randomized, controlled, prospective clinical trial is to evaluate the&#xD;
      performances of a universal adhesive in three different application modes, a self-etch&#xD;
      adhesive and an etch&amp;rinse adhesive in restoration of non-caries cervical lesions.&#xD;
      Thirty-four patients will receive restorations. Lesions will be divided into 5 groups&#xD;
      according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in&#xD;
      self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil&#xD;
      Universal Bond Quick in etch&amp;rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond.&#xD;
      Restorations (Tetric N-Ceram composite) will be scored with regard to retention, marginal&#xD;
      discoloration, marginal adaptation, recurrent caries and post operative sensitivity using&#xD;
      modified USPHS criteria after 48 months. Two examiners who is not involved in the placement&#xD;
      of restorations will conduct the evaluations. Descriptive statistics will be performed using&#xD;
      Chi-square tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 10, 2018</start_date>
  <completion_date type="Anticipated">June 10, 2024</completion_date>
  <primary_completion_date type="Actual">May 10, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performances of different adhesives</measure>
    <time_frame>two years</time_frame>
    <description>Two year examinations according to USPHS criteria</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Tooth Wear</condition>
  <arm_group>
    <arm_group_label>Clearfil Universal Bond Quick, self-etch mode (CU-SE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Clearfil Universal Bond Quick, selective etch mode (CU-SLE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Clearfil Universal Bond Quick, etch&amp;rinse mode (CU-ER)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Clearfil SE Bond (CSE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tetric N-Bond (TB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clearfil Universal Bond Quick</intervention_name>
    <description>Adhesive systems</description>
    <arm_group_label>Clearfil Universal Bond Quick, self-etch mode (CU-SE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clearfil Universal Bond Quick</intervention_name>
    <description>Adhesive systems</description>
    <arm_group_label>Clearfil Universal Bond Quick, selective etch mode (CU-SLE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clearfil Universal Bond Quick</intervention_name>
    <description>Adhesive systems</description>
    <arm_group_label>Clearfil Universal Bond Quick, etch&amp;rinse mode (CU-ER)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clearfil SE Bond</intervention_name>
    <description>Adhesive systems</description>
    <arm_group_label>Clearfil SE Bond (CSE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tetric N-Bond</intervention_name>
    <description>Adhesive systems</description>
    <arm_group_label>Tetric N-Bond (TB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being 18 years or older,&#xD;
&#xD;
          -  having no medical or behavioral problems preventing then from attending review visits,&#xD;
&#xD;
          -  having at least 5 tooth with NCCLs&#xD;
&#xD;
          -  having antagonist teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor gingival health,&#xD;
&#xD;
          -  uncontrolled, rampant caries,&#xD;
&#xD;
          -  bruxism,&#xD;
&#xD;
          -  removable partial dentures,&#xD;
&#xD;
          -  xerostomia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Dr. Fatma Dilşad Öz</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>Tooth Wear</mesh_term>
  </condition_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/NCT04481087
org study id: NCCLs universal
nct id: NCT04481087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized, controlled, prospective clinical trial is to evaluate the
      performances of a universal adhesive in three different application modes, a self-etch
      adhesive and an etch&rinse adhesive in restoration of non-caries cervical lesions.
      Thirty-four patients will receive restorations. Lesions will be divided into 5 groups
      according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in
      self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil
      Universal Bond Quick in etch&rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond.
      Restorations (Tetric N-Ceram composite) will be scored with regard to retention, marginal
      discoloration, marginal adaptation, recurrent caries and post operative sensitivity using
      modified USPHS criteria after 48 months. Two examiners who is not involved in the placement
      of restorations will conduct the evaluations. Descriptive statistics will be performed using
      Chi-square tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical performances of different adhesives
time frame: two years
description: Two year examinations according to USPHS criteria
arm group label: Clearfil Universal Bond Quick, self-etch mode (CU-SE)
arm group type: Experimental
arm group label: Clearfil Universal Bond Quick, selective etch mode (CU-SLE)
arm group type: Experimental
arm group label: Clearfil Universal Bond Quick, etch&rinse mode (CU-ER)
arm group type: Experimental
arm group label: Clearfil SE Bond (CSE)
arm group type: Experimental
arm group label: Tetric N-Bond (TB)
arm group type: Experimental
intervention type: Device
intervention name: Clearfil Universal Bond Quick
description: Adhesive systems
arm group label: Clearfil Universal Bond Quick, self-etch mode (CU-SE)
intervention type: Device
intervention name: Clearfil Universal Bond Quick
description: Adhesive systems
arm group label: Clearfil Universal Bond Quick, selective etch mode (CU-SLE)
intervention type: Device
intervention name: Clearfil Universal Bond Quick
description: Adhesive systems
arm group label: Clearfil Universal Bond Quick, etch&rinse mode (CU-ER)
intervention type: Device
intervention name: Clearfil SE Bond
description: Adhesive systems
arm group label: Clearfil SE Bond (CSE)
intervention type: Device
intervention name: Tetric N-Bond
description: Adhesive systems
arm group label: Tetric N-Bond (TB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Dr. Fatma Dilşad Öz
investigator title: Associate Professor
mesh term: Tooth Wear