<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/NCT03303742</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-10-03</org_study_id>
    <nct_id>NCT03303742</nct_id>
  </id_info>
  <brief_title>Feather Edge Versus Deep Chamfer Finish Line Marginal Design in Complete Coverage Bruxzir Zirconia Crowns</brief_title>
  <official_title>Evaluation of Patient Satisfaction, Color Difference, Marginal Integrity and Survival of Bruxzir Zirconia Complete Coverage Crowns With Feather Edge Versus Deep Chamfer Finish Line Marginal Design.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Evaluation of patient satisfaction, color difference, marginal integrity and survival of&#xD;
      Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line&#xD;
      marginal design.&#xD;
&#xD;
      (Randomised Controlled Trial)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 10, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2022</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>patient satisfaction</measure>
    <time_frame>one year</time_frame>
    <description>patient satisfaction will be measured by questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Premolars Need Full Coverage Restoration</condition>
  <arm_group>
    <arm_group_label>feather edge finish line marginal design</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>deep chamfer finish line marginal design</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>deep chamfer</intervention_name>
    <description>finish line marginal design of a full coverage crown preparation</description>
    <arm_group_label>deep chamfer finish line marginal design</arm_group_label>
    <other_name>rounded shoulder</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>feather edge</intervention_name>
    <description>finish line marginal design of a full coverage crown preparation</description>
    <arm_group_label>feather edge finish line marginal design</arm_group_label>
    <other_name>knife edge</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19-50 years.&#xD;
&#xD;
          -  Males or females.&#xD;
&#xD;
          -  Co-operative patients approving to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 19 years old&#xD;
&#xD;
          -  Disabilities&#xD;
&#xD;
          -  Systemic diseases or severe medically compromised&#xD;
&#xD;
          -  Lack of compliance of the patient contributed in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sara Hussein Elbasha</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sara Elbasha</investigator_full_name>
    <investigator_title>assistant lecturer of fixed prosthodontics/ahram canadian university</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03303742
org study id: CEBD-CU-2017-10-03
nct id: NCT03303742
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of patient satisfaction, color difference, marginal integrity and survival of
      Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line
      marginal design.

      (Randomised Controlled Trial)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: patient satisfaction
time frame: one year
description: patient satisfaction will be measured by questionnaire
arm group label: feather edge finish line marginal design
arm group type: Experimental
description: intervention
arm group label: deep chamfer finish line marginal design
arm group type: Active Comparator
description: comparator
intervention type: Other
intervention name: deep chamfer
description: finish line marginal design of a full coverage crown preparation
arm group label: deep chamfer finish line marginal design
other name: rounded shoulder
intervention type: Other
intervention name: feather edge
description: finish line marginal design of a full coverage crown preparation
arm group label: feather edge finish line marginal design
other name: knife edge
criteria: 
gender: All
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sara Elbasha
investigator title: assistant lecturer of fixed prosthodontics/ahram canadian university
sharing ipd: Undecided