<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/NCT03779607</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-13</org_study_id>
    <nct_id>NCT03779607</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials</brief_title>
  <official_title>Clinical Evaluation and Patient Satisfaction Ofshade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials (Randomized Controlled Clinical Trial)</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>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>
      evaluation of color difference between zirconia reinforced lithium silicate (celtra press) VS&#xD;
      lithium disilicate (Emax) in relation to natural tooth structure to determine which&#xD;
      monolithic material will provide restoration with exact shade and optical properties as&#xD;
      natural tooth structure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      eligible patients will be randomized in 2 equal group between study group (celtra press) and&#xD;
      control group (Emax) .&#xD;
&#xD;
      Single tooth in esthetic zone requiring full coverage crown is prepared to receive an all&#xD;
      ceramic crown of .&#xD;
&#xD;
      Grouping: The crowns will be divided into two groups:&#xD;
&#xD;
      I:Teeth receiving crowns fabricated from IPS emax press ( ivoclarvivadent) II:Teeth receiving&#xD;
      crowns fabricatedfrom Celtrapress(dentsplysirona).&#xD;
&#xD;
      Shade will be measured using intraoral spectrophotometer and evaluated.&#xD;
&#xD;
      The color difference (ΔE ) will be calculated for each sample using the following equation:&#xD;
      ΔE =[(ΔL*)²+(Δa*)² + (Δb*)²]½&#xD;
&#xD;
      ΔE (perceptibility threshold ) will be evaluated for each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 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 cementation</time_frame>
    <description>using USPHS scoring system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>immediately after crown cementation</time_frame>
    <description>Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Natural Optical Properties</condition>
  <arm_group>
    <arm_group_label>IPS e.max Press(lithium di silicate)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lithium disilicate reinforced glass ceramics are available in the market in two forms according to the technique of manufacturing, either heat pressed ingots or CAD/CAM blocks for milling. The heat pressed lithium disilicate glass ceramic consists of approximately 70% lithium disilicatecrystals(the main crystal phase) having a needle like shape that are embedded in a glassy matrix. The crystals length is about 3 to 6 μm. The heat pressed ingots are fully crystallized and the restoration is fabricated by the lost wax technique where the lithium disilicate ingots are pressed into the investment mold at high temperature. The pressed lithium disilicate has strong flexural strength values(range 400 ± 40 MPa)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celtra Press</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.&#xD;
Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Celtra Press</intervention_name>
    <description>new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.&#xD;
Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.</description>
    <arm_group_label>Celtra Press</arm_group_label>
    <arm_group_label>IPS e.max Press(lithium di silicate)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. 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;
             2. Patients able physically and psychologically to tolerate conventional restorative&#xD;
             procedures.&#xD;
&#xD;
             3. Patients with no active periodontal or pulpal diseases, having teeth with good&#xD;
             restorations.&#xD;
&#xD;
             4. Patients with teeth problems indicated for full coverage restoration ( coronal&#xD;
             fracture where partial coverage would lack retention, malposed or malformed teeth).&#xD;
&#xD;
             5. Patients with root canal treated teeth requiring full coverage restorations with&#xD;
             contralatral tooth not filled orfractured.&#xD;
&#xD;
             6. Patients willing to return for follow-up examinations and evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients in the growth stage with partially erupted teeth.&#xD;
&#xD;
          2. Patients with poor oral hygiene and motivation.&#xD;
&#xD;
          3. 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;
          4. Patients with psychiatric problems or unrealistic expectation&#xD;
&#xD;
          5. Patients have no opposite occluding dentition in the area intended for restoration\&#xD;
&#xD;
          6. Patients suffer from parafunctional habits.&#xD;
&#xD;
          7. deep discoloration of abutment .&#xD;
&#xD;
          8. Smokers and heavy caffeine consumers.&#xD;
&#xD;
             -&#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_official>
    <last_name>Mohamed zamzam, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maha Taymour, Associate professor</last_name>
    <role>Study Director</role>
    <affiliation>Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mohamed bekhiet, master degree student</last_name>
    <phone>01224238808</phone>
    <email>mohamed.bekhet@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed el sayed bekhiet</investigator_full_name>
    <investigator_title>Resident - Fixed prosthodontic department- Faculty of oral and dental medicine</investigator_title>
  </responsible_party>
  <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/NCT03779607
org study id: CEBD-CU-2018-11-13
nct id: NCT03779607
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
evaluation of color difference between zirconia reinforced lithium silicate (celtra press) VS
      lithium disilicate (Emax) in relation to natural tooth structure to determine which
      monolithic material will provide restoration with exact shade and optical properties as
      natural tooth structure.
eligible patients will be randomized in 2 equal group between study group (celtra press) and
      control group (Emax) .

      Single tooth in esthetic zone requiring full coverage crown is prepared to receive an all
      ceramic crown of .

      Grouping: The crowns will be divided into two groups:

      I:Teeth receiving crowns fabricated from IPS emax press ( ivoclarvivadent) II:Teeth receiving
      crowns fabricatedfrom Celtrapress(dentsplysirona).

      Shade will be measured using intraoral spectrophotometer and evaluated.

      The color difference (ΔE ) will be calculated for each sample using the following equation:
      ΔE =[(ΔL*)²+(Δa*)² + (Δb*)²]½

      ΔE (perceptibility threshold ) will be evaluated for each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Color match
time frame: immediately after crown cementation
description: using USPHS scoring system
measure: Patient satisfaction
time frame: immediately after crown cementation
description: Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)
arm group label: IPS e.max Press(lithium di silicate)
arm group type: Active Comparator
description: Lithium disilicate reinforced glass ceramics are available in the market in two forms according to the technique of manufacturing, either heat pressed ingots or CAD/CAM blocks for milling. The heat pressed lithium disilicate glass ceramic consists of approximately 70% lithium disilicatecrystals(the main crystal phase) having a needle like shape that are embedded in a glassy matrix. The crystals length is about 3 to 6 μm. The heat pressed ingots are fully crystallized and the restoration is fabricated by the lost wax technique where the lithium disilicate ingots are pressed into the investment mold at high temperature. The pressed lithium disilicate has strong flexural strength values(range 400 ± 40 MPa)
arm group label: Celtra Press
arm group type: Experimental
description: new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.
Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.
intervention type: Other
intervention name: Celtra Press
description: new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.
Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.
arm group label: Celtra Press
arm group label: IPS e.max Press(lithium di silicate)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mohamed zamzam, professor
role: Principal Investigator
affiliation: Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
last name: Maha Taymour, Associate professor
role: Study Director
affiliation: Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
last name: mohamed bekhiet, master degree student
phone: 01224238808
email: mohamed.bekhet@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed el sayed bekhiet
investigator title: Resident - Fixed prosthodontic department- Faculty of oral and dental medicine
mesh term: Mouth, Edentulous
sharing ipd: Undecided