<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/NCT03813628</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-09-23</org_study_id>
    <nct_id>NCT03813628</nct_id>
  </id_info>
  <brief_title>Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols</brief_title>
  <official_title>Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics &quot;Celtra Press&quot; Treated With Different Surface Finishing Protocols.</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>
      investigating the effect of glazing and polishing on the color difference between natural&#xD;
      teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate&#xD;
      ceramic).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups of patients will be selected according to special inclusion criteria N=5 in each&#xD;
      group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced&#xD;
      lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of&#xD;
      the same material , after crowns delivery color difference (ΔE) between the natural teeth and&#xD;
      the celtra press crown will be measured by a spectrophotometer device (intra oral) and&#xD;
      patient satisfaction will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 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>color match</measure>
    <time_frame>immediately after crown delivery</time_frame>
    <description>Color match will be measured using &quot;United states pulplic health service &quot; system .&#xD;
Scale system :&#xD;
Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible&#xD;
Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade&#xD;
Charlie : Obvious mismatch, beyond the normal range&#xD;
Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Color difference</measure>
    <time_frame>immediately after crown delivery</time_frame>
    <description>The color difference (ΔE) will be measured using spectrophotometer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>immediately after crown delivery</time_frame>
    <description>Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Natural Optical Properties</condition>
  <arm_group>
    <arm_group_label>polished celtra press full coverage crowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glazed celtra press full coverage crowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>contralateral natural teeth</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>polished celtra press full coverage crown</intervention_name>
    <description>a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing</description>
    <arm_group_label>polished celtra press full coverage crowns</arm_group_label>
    <other_name>polished all ceramic crown</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glazed celtra press full coverage crowns</intervention_name>
    <description>a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing</description>
    <arm_group_label>glazed celtra press full coverage crowns</arm_group_label>
    <other_name>glazed all ceramic crown</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>contralateral natural teeth</intervention_name>
    <description>the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth</description>
    <arm_group_label>contralateral natural teeth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range of the patients from 20-45 years old; able to read and sign the informed&#xD;
             consent document, illiterate patient will be avoided.&#xD;
&#xD;
          -  Patients able physically and psychologically to tolerate conventional restorative&#xD;
             procedures.&#xD;
&#xD;
          -  Patients with no active periodontal or pulpal diseases, having teeth with good&#xD;
             restorations.&#xD;
&#xD;
          -  Patients with teeth problems indicated for full coverage restoration ( coronal&#xD;
             fracture where partial coverage would lack retention, malposed or malformed teeth).&#xD;
&#xD;
          -  Patients with root canal treated teeth requiring full coverage restorations with&#xD;
             contralatral tooth not filled or fractured.&#xD;
&#xD;
          -  Patients willing to return for follow-up examinations and evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in the growth stage with partially erupted teeth.&#xD;
&#xD;
          -  Patients with poor oral hygiene and motivation.&#xD;
&#xD;
          -  Pregnant women's to avoid any complication that may occur in dental office due to&#xD;
             pregnancy or due to injected anesthetic solution.&#xD;
&#xD;
          -  Patients with psychiatric problems or unrealistic expectation&#xD;
&#xD;
          -  Deep discoloration of abutment .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>nourhan sayed</last_name>
    <phone>01117911384</phone>
    <email>nourhan.sayed@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nurhan Sayed Saleh Ahmed</investigator_full_name>
    <investigator_title>Principal investigator - Fixed prosthodontic department, faculty of oral and dental medicine</investigator_title>
  </responsible_party>
  <keyword>celtra press</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <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/NCT03813628
org study id: CEBD-CU-2018-09-23
nct id: NCT03813628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
investigating the effect of glazing and polishing on the color difference between natural
      teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate
      ceramic).
Two groups of patients will be selected according to special inclusion criteria N=5 in each
      group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced
      lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of
      the same material , after crowns delivery color difference (ΔE) between the natural teeth and
      the celtra press crown will be measured by a spectrophotometer device (intra oral) and
      patient satisfaction will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: color match
time frame: immediately after crown delivery
description: Color match will be measured using "United states pulplic health service " system .
Scale system :
Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible
Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade
Charlie : Obvious mismatch, beyond the normal range
Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence
measure: Color difference
time frame: immediately after crown delivery
description: The color difference (ΔE) will be measured using spectrophotometer
measure: patient satisfaction
time frame: immediately after crown delivery
description: Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
arm group label: polished celtra press full coverage crowns
arm group type: Experimental
description: a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
arm group label: glazed celtra press full coverage crowns
arm group type: Experimental
description: a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
arm group label: contralateral natural teeth
arm group type: Active Comparator
description: the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth
intervention type: Other
intervention name: polished celtra press full coverage crown
description: a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
arm group label: polished celtra press full coverage crowns
other name: polished all ceramic crown
intervention type: Other
intervention name: glazed celtra press full coverage crowns
description: a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
arm group label: glazed celtra press full coverage crowns
other name: glazed all ceramic crown
intervention type: Other
intervention name: contralateral natural teeth
description: the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth
arm group label: contralateral natural teeth
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: nourhan sayed
phone: 01117911384
email: nourhan.sayed@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nurhan Sayed Saleh Ahmed
investigator title: Principal investigator - Fixed prosthodontic department, faculty of oral and dental medicine
mesh term: Mouth, Edentulous
sharing ipd: Undecided