<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/NCT03295513</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-21</org_study_id>
    <nct_id>NCT03295513</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia</brief_title>
  <official_title>Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (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>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 study is to evaluate chipping and the degree of natural enamel loss opposing&#xD;
      to monolithic zirconia compared to veneered zirconia restoration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While increase using of zirconia in extra coronal restoration as a substitute for metal&#xD;
      ceramic restoration still high rate of technical complications specifically chipping of&#xD;
      veneering ceramic and wear of antagonist are usually associated with veneered zirconia&#xD;
      restoration which led to development of new monolithic zirconia to overcome these technical&#xD;
      complications.&#xD;
&#xD;
      Therefore this study will be conducted to evaluate chipping and wear of antagonist of&#xD;
      veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.&#xD;
&#xD;
      Benefits of the research to the patient:&#xD;
&#xD;
      Patient will receive a restoration with superior function, esthetics, and quality.&#xD;
&#xD;
      It will save teeth such as mutilated teeth, endodontically treated and teeth with massive&#xD;
      loss of tooth structure that cannot be restored with direct restoration.&#xD;
&#xD;
      As a result of properly functioning restoration, teeth will be restored with predictable&#xD;
      prognosis and the patient will be psychologically improved.&#xD;
&#xD;
      Benefits of the research to the clinician:&#xD;
&#xD;
      Practitioner will have the advantage to clinically assess a new material that can be used in&#xD;
      different situations for better function and esthetic outcomes.&#xD;
&#xD;
      It will improve patient confidence with the dentist.&#xD;
&#xD;
      Explanation for choice of comparators:&#xD;
&#xD;
      The use of veneered zirconia is well documented in the literatures as successful restoration&#xD;
      modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns&#xD;
      revealed no chipping for veneered zirconia.&#xD;
&#xD;
      A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic&#xD;
      Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D=&#xD;
      2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis&#xD;
      reported Alpha scores greater than 95% indicating no predictable changes during the 5 years&#xD;
      Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed&#xD;
      dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and&#xD;
      70% reported bravo after 3 years of clinical use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <intervention_model_description>Patient will receive a restoration with superior function, esthetics, and quality.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chipping</measure>
    <time_frame>12 month</time_frame>
    <description>chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tooth wear</measure>
    <time_frame>12 month</time_frame>
    <description>Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Broken Tooth With Complication</condition>
  <condition>Non Vital Teeth</condition>
  <condition>Mutilated Teeth</condition>
  <arm_group>
    <arm_group_label>veneered zirconia full coverage restorations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>InCoris zirconia material (TZI-Densupply sirona)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monolithic zirconia full coverage restorations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>InCoris (TZI-Densupply sirona)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Veneered zirconia</intervention_name>
    <description>he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia</description>
    <arm_group_label>veneered zirconia full coverage restorations</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monolithic zirconia</intervention_name>
    <description>Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced</description>
    <arm_group_label>Monolithic zirconia full coverage restorations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age range of the patients from 20-60 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 (e.g. Moderate to&#xD;
             severe discoloration, coronal fracture where partial coverage would lack retention,&#xD;
             malposed or malformed teeth).&#xD;
&#xD;
          5. Patients with root canal treated teeth requiring full coverage restorations.&#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. A pregnant woman'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 (patient that has phobia&#xD;
             from dental treatments or needle bunch).&#xD;
&#xD;
          5. Patients have no opposite occluding dentition in the area intended for restoration.&#xD;
&#xD;
          6. Patients suffer from Para functional habits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nouran M Ibrahim</last_name>
    <phone>01149928886</phone>
    <phone_ext>+20</phone_ext>
    <email>nouran.mahmoud@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nouran Mahmoud Ibrahim Metwally</investigator_full_name>
    <investigator_title>mSc</investigator_title>
  </responsible_party>
  <keyword>mutilated, root canal treated teeth, and coronal fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Nonvital</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/NCT03295513
org study id: CEBD-CU-2017-09-21
nct id: NCT03295513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing
      to monolithic zirconia compared to veneered zirconia restoration.
While increase using of zirconia in extra coronal restoration as a substitute for metal
      ceramic restoration still high rate of technical complications specifically chipping of
      veneering ceramic and wear of antagonist are usually associated with veneered zirconia
      restoration which led to development of new monolithic zirconia to overcome these technical
      complications.

      Therefore this study will be conducted to evaluate chipping and wear of antagonist of
      veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.

      Benefits of the research to the patient:

      Patient will receive a restoration with superior function, esthetics, and quality.

      It will save teeth such as mutilated teeth, endodontically treated and teeth with massive
      loss of tooth structure that cannot be restored with direct restoration.

      As a result of properly functioning restoration, teeth will be restored with predictable
      prognosis and the patient will be psychologically improved.

      Benefits of the research to the clinician:

      Practitioner will have the advantage to clinically assess a new material that can be used in
      different situations for better function and esthetic outcomes.

      It will improve patient confidence with the dentist.

      Explanation for choice of comparators:

      The use of veneered zirconia is well documented in the literatures as successful restoration
      modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns
      revealed no chipping for veneered zirconia.

      A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic
      Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D=
      2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis
      reported Alpha scores greater than 95% indicating no predictable changes during the 5 years
      Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed
      dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and
      70% reported bravo after 3 years of clinical use.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient will receive a restoration with superior function, esthetics, and quality.
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Chipping
time frame: 12 month
description: chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
measure: tooth wear
time frame: 12 month
description: Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
arm group label: veneered zirconia full coverage restorations
arm group type: Active Comparator
description: InCoris zirconia material (TZI-Densupply sirona)
arm group label: Monolithic zirconia full coverage restorations
arm group type: Experimental
description: InCoris (TZI-Densupply sirona)
intervention type: Other
intervention name: Veneered zirconia
description: he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia
arm group label: veneered zirconia full coverage restorations
intervention type: Other
intervention name: Monolithic zirconia
description: Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced
arm group label: Monolithic zirconia full coverage restorations
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nouran M Ibrahim
phone: 01149928886
phone ext: +20
email: nouran.mahmoud@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nouran Mahmoud Ibrahim Metwally
investigator title: mSc
mesh term: Tooth, Nonvital