<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/NCT03298152</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-29</org_study_id>
    <nct_id>NCT03298152</nct_id>
  </id_info>
  <brief_title>One Year Clinical Evaluation of E-max CAD Versus Cerasmart Endocrowns in Anterior Endodontically Treated Teeth</brief_title>
  <official_title>One Year Clinical Evaluation of E-max CAD Versus Cerasmart Endocrowns in Anterior Endodontically Treated Teeth:A Randomized 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>
      Nowadays Endocrowns are classified as conservative treatment modality for restoration of&#xD;
      Endodontically treated teeth in which pulp chamber is used as a retentive resource.&#xD;
&#xD;
      With the advancement in technology in the field of adhesive dentistry its use is increasing&#xD;
      day by day in clinical practice. Acid Etchable ceramics such as lithium Disilicate based&#xD;
      ceramics are the gold standard ceramic material used for Endocrowns. The Etchable property&#xD;
      and the translucent character of lithium Disilicate enhance strength and esthetic property.&#xD;
&#xD;
      A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) contain high&#xD;
      density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high&#xD;
      strength and unique aesthetics. full homogeneous and even distribution of nano ceramic&#xD;
      network lead to unique physical properties for cerasmart . Uniform scuttle (very short&#xD;
      inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™&#xD;
      with high strength and acceptable level of marginal adaptation.&#xD;
&#xD;
      So, it can perfectly use in posterior, anterior, inlay, onlay, and implant restorations and&#xD;
      also enables minimum tooth reduction for more conservative restoration.&#xD;
&#xD;
      Awad et al (1) found that Cerasmart showed significantly higher flexural strength and modulus&#xD;
      of elasticity, with lower flexural modulus values compared to other groups. Also, result in&#xD;
      smoother margins compared with other types of ceramic.&#xD;
&#xD;
      So, present research will evaluate patient satisfaction, bonding properties and marginal&#xD;
      adaptation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will carried out on patients collected from the dental clinics in fixed&#xD;
      prosthodontics clinic, Faculty of Dentistry, Cairo University&#xD;
&#xD;
      the visits will be designed as follows:&#xD;
&#xD;
      .1st visit: (N.N) will call participants before tooth preparation procedure for X-ray&#xD;
      reviewing and pre-operative photographing using a Professional digital camera also;&#xD;
      Impression will be taken using the alginate impression material * for study cast analysis&#xD;
      with suitable stock tray** size.&#xD;
&#xD;
      Each participant will be asked to sign consent form written in patient native language.&#xD;
&#xD;
      2nd visit: (Tooth preparation) After performing adequate disinfection and sterilization&#xD;
      process for each instrument and tools will be used in this trial; the anesthetic solution&#xD;
      (Anesthetic solution: Septanest SP, 4%, Septodont, France.) will be injected using&#xD;
      infiltration technique. Then patients will be left from five to ten minutes then; the&#xD;
      operator will check with the subjective for anasthesia.&#xD;
&#xD;
      Full preparation will be carried out following the principles of Endocrown preparation with&#xD;
      deep chamfer finish line while 2 observers will select visually the appropriate shade. Final&#xD;
      vinylpolysiloxane impressions will be taken for each participant in each groupusing the&#xD;
      suitable tray size.&#xD;
&#xD;
      After final setting impressions will be checked for accuracy using magnifying loops&#xD;
      (Magnifying loop: Univet optical technologies, Italy).&#xD;
&#xD;
      Then protemp temporary endocrowns ) Temporary crown material: Structure, Voco, GMBH,&#xD;
      Germany.( will be cemented using eugenol free (Temporary cement: RelyX Temp, USA).&#xD;
&#xD;
      Impressions will be sent to the lab, poured with extra hard stone material. Then it will be&#xD;
      removed from the impression after complete setting.&#xD;
&#xD;
      Endorowns for each patient will be fabricated using either lithium di-silicate material&#xD;
      (Emax) or Cerasmart blocks according to the random allocation of the patients&#xD;
&#xD;
      3rd visit: Participants will be called again for final cementation. Temporary crown will be&#xD;
      removed and abutments will be cleaned of any residues using pumice slurry ) Pumice slurry:&#xD;
      DCL, Dental composite LTD, England.( applied with bristle brush and rubber cup under water&#xD;
      irrigation.&#xD;
&#xD;
      Proper isolation will be done before cementation then permanent dual cure resin cement&#xD;
      (Permanent cement: Bifix-QM, Voco Gmbh, Germany ) will be used for luting of permanent crowns&#xD;
      according to manufacturer instructions. Ask the patients to hold the crown under occlusal&#xD;
      compression until luting cement polymerization. 5 minutes later, excess cement will be&#xD;
      removed.&#xD;
&#xD;
      Measuring of different outcomes will start in this visit for all patients.&#xD;
&#xD;
      The following assessment surveys (clinical evaluations) will done for both groups:&#xD;
&#xD;
      All patients will be recalled after 3, 6, 9, and 12 months. For each recall examination,&#xD;
      evaluator will performed the direct clinical evaluation using modified USPHS criteria for&#xD;
      margin integrity and gross fracture.&#xD;
&#xD;
      Visual inspection will be used for gross fracture evaluation. Endorowns that intact and fully&#xD;
      retained will be rated 'Alfa', Endocrowns with partially retained with some portion of the&#xD;
      restoration still intact will be rated as 'Bravo'and endocrowns completely missing will be&#xD;
      rated as 'Charlie'.&#xD;
&#xD;
      Visual inspection and explorer will be using for marginal integrity evaluation. Endocrowns&#xD;
      with no catch with The explorer and no visible crevice along the periphery of the restoration&#xD;
      will be rated as Alpha (A), Endocrowns with explorer catches with visible evidence of a&#xD;
      crevice, with and/or the base is not exposed, and the restoration is not mobile will be rated&#xD;
      as Bravo (B) and endocrowms with explorer penetrates and extended to the dento-enamel&#xD;
      junction will be rated as Charlie ©.&#xD;
&#xD;
      In addition, questionnaires will be used to evaluate patients' satisfaction and potential&#xD;
      postoperative discomfort as the following questions:&#xD;
&#xD;
        1. Are you satisfied with your endocrown appearance?&#xD;
&#xD;
        2. Are you satisfied with your endocrown shade?&#xD;
&#xD;
        3. Do you feel your endocrown are poorly aligned?&#xD;
&#xD;
        4. Do you feel your endocrown are protruding?&#xD;
&#xD;
        5. Are you hiding your teeth while smiling?&#xD;
&#xD;
      Adherence improvement session will be taking place in the initial visit. This session will&#xD;
      include:&#xD;
&#xD;
        -  Each patient will be informed about the study steps and maintain oral hygiene.&#xD;
           Subsequent sessions will occur at the follow-up visits.&#xD;
&#xD;
        -  The patients will be trained for tooth brushing, flossing and instructed all oral&#xD;
           hygiene methods after each meal.&#xD;
&#xD;
        -  Instruct the patients to record any abnormalities or mobility in endocrowns.&#xD;
&#xD;
        -  Recall appointment will be performed every two months for aduration of one year to&#xD;
           stress on oral hygiene.&#xD;
&#xD;
        -  Data collection methods:&#xD;
&#xD;
      Prosthodontic colleague will assess the outcome of each group. Data will be collected on&#xD;
      excel sheets. All categorical data will be presented as risk ratios, while numerical data&#xD;
      will be presented by mean and standard deviation. All data will be reported at a confidence&#xD;
      interval of 95% and a p value of 5%.&#xD;
&#xD;
      Each factor will be measured as explained in the outcome table. - Outcome results will be&#xD;
      written down on the patients' folders by (NN), then will be given to (JG) for data&#xD;
      management. All the information will be transferred on excel sheets and saved on a computer&#xD;
      in safe place and locked with a password only known to JG. A copy of the data will be saved&#xD;
      on a flash drive with JG to provide a back up for the data.&#xD;
&#xD;
      Plans to increase participant retention &amp; complete follow-up:&#xD;
&#xD;
      Telephone numbers of each patients and address will be taken and included in study, then&#xD;
      phone calls and messages will be sent to remind patients before each appointment.&#xD;
&#xD;
      Data management:&#xD;
&#xD;
      JG will enter all data electronically. Patient files are to stored in numerical order in a&#xD;
      secured place. J.G and A.Z will have access to data&#xD;
&#xD;
      Data Monitoring:&#xD;
&#xD;
      AZ will be responsible of data monitoring if any lost or delete occurs, in that case: back up&#xD;
      data will be taken from (J.G) to provide hard copy for the requested data and A.Z will make&#xD;
      final decision.&#xD;
&#xD;
      Harms:&#xD;
&#xD;
      If 50% of the patients showed any unfavorable signs as sever pain, irreparable fracture or&#xD;
      shade changes which might affect the results. Then the treatment will be considered as&#xD;
      stopped guidelines which necessitate stopping the treatment and interim analysis will be&#xD;
      performed.&#xD;
&#xD;
      Auditing:&#xD;
&#xD;
      Auditing of the study design will be done by (AZ).&#xD;
&#xD;
      Ethics and dissemination Research ethics approval Protocol and informed consent form will be&#xD;
      reviewed by the Ethics Committee of Scientific Research - faculty of Dentistry - Cairo&#xD;
      University.&#xD;
&#xD;
      Protocol amendments:&#xD;
&#xD;
      Any changes in protocol affect the conduct of the study, benefit for patient or patient&#xD;
      safety, including changes in study objectives, study design, sample size, study procedures,&#xD;
      or significant administrative aspect will require formal amendment to the protocol. Such&#xD;
      amendment will be agreed upon by the Council of Department of fixed prosthodontics, Faculty&#xD;
      of Dentistry, Cairo University.&#xD;
&#xD;
      Consent:&#xD;
&#xD;
      Researcher will discuss the trial with all patients. Then patient can have an informed&#xD;
      discussion with the researcher. Researcher will obtain written consent from patients willing&#xD;
      to participate in the trial. All consent forms will write in Arabic language (Appendix 1.1).&#xD;
&#xD;
      Confidentiality:&#xD;
&#xD;
      All information related to study will store securely. All participants' information will&#xD;
      store in locked cabinets in areas with limited access. To maintain participant&#xD;
      confidentiality all data collection, process, and administrative forms will identify only by&#xD;
      a coded ID number. All information related to patient names or other personal identifiers&#xD;
      will store separately identified by code number. All local databases will be secured with&#xD;
      password-protected access systems.&#xD;
&#xD;
      Access to data:&#xD;
&#xD;
      The investigator and supervisors will give access to the data sets. All data sets will be&#xD;
      protected by password. To ensure confidentiality, Participant study information will become&#xD;
      confidentially.&#xD;
&#xD;
      Ancillary and post-trial care:&#xD;
&#xD;
      All patients will be followed up 2 years even after the trial ends then might be used for&#xD;
      further cohort study.&#xD;
&#xD;
      Dissemination policy:&#xD;
&#xD;
      o Study results will be published as partial fulfillment the Requirements for PHD degree in&#xD;
      fixed prosthodontics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">February 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>Gross Fracture</measure>
    <time_frame>one year</time_frame>
    <description>Categorical Alpha (A): Restoration is intact and fully retained.&#xD;
Bravo (B): Restoration is partially retained with some parts of the restoration still intact.&#xD;
Charlie (C): Restoration is completely missing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>one year</time_frame>
    <description>score by Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal Integrity</measure>
    <time_frame>one year</time_frame>
    <description>Categorical Alpha (A): The explorer does not catch and no visible crevice along the periphery of the restoration.&#xD;
Bravo (B): The explorer catches and with visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. Both dentin and/or the base is not exposed, and no mobility in the restoration.&#xD;
Charlie ©: The explorer penetrates and extended to the dento-enamel junction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Endodontically Treated Teeth</condition>
  <arm_group>
    <arm_group_label>Emax CAD Endocrowns</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using lithium disilicate e.max restorations is documented in literature as a successful restoration. Two different ceramic crowns systems were investigated clinically for three-years and howed that patient was satisfied with the final restoration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cerasmart Endocrowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) with high density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high strength and unique aesthetics. full homogeneous and even distribution nano ceramic network lead to unique physical properties for cerasmart . Uniform scuttle (very short inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™ with exceptional strength, retention, acceptable level of marginal adaptation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CERASMART Endocrown</intervention_name>
    <description>Endocrown fixed restoration used to restore endodontically treated anterior teeth using CERASMART blocks</description>
    <arm_group_label>Cerasmart Endocrowns</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Emax Endocrown</intervention_name>
    <description>Endocrown fixed restoration used to restore endodontically treated anterior teeth using Emax material</description>
    <arm_group_label>Emax CAD Endocrowns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1. Age range of the patients from 20-60 years old who can read and sign informed consent&#xD;
        document.&#xD;
&#xD;
        2. Medically free patients or with controlled systemic disease. 3. No active periodontal&#xD;
        disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - 1. Patients under 20 years old. 2. Patients with bad oral hygiene and motivation. 3.&#xD;
        Patients with psychiatric problems or unrealistic expectation (patient have phobia from&#xD;
        dental treatments or needle bricks).&#xD;
&#xD;
        4. Patients with parafunctional habits (clencing/bruxism).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Norhan Abd El Haliem, MDs</last_name>
    <phone>002</phone>
    <phone_ext>01007105072</phone_ext>
    <email>norhan.naief@dentistry.cu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Norhan Naief Abd El Haliem</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>lithium disilicate endocrowns</keyword>
  <keyword>cerasmart endocrowns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Nonvital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03298152
org study id: CEBD-CU-2017-09-29
nct id: NCT03298152
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nowadays Endocrowns are classified as conservative treatment modality for restoration of
      Endodontically treated teeth in which pulp chamber is used as a retentive resource.

      With the advancement in technology in the field of adhesive dentistry its use is increasing
      day by day in clinical practice. Acid Etchable ceramics such as lithium Disilicate based
      ceramics are the gold standard ceramic material used for Endocrowns. The Etchable property
      and the translucent character of lithium Disilicate enhance strength and esthetic property.

      A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) contain high
      density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high
      strength and unique aesthetics. full homogeneous and even distribution of nano ceramic
      network lead to unique physical properties for cerasmart . Uniform scuttle (very short
      inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™
      with high strength and acceptable level of marginal adaptation.

      So, it can perfectly use in posterior, anterior, inlay, onlay, and implant restorations and
      also enables minimum tooth reduction for more conservative restoration.

      Awad et al (1) found that Cerasmart showed significantly higher flexural strength and modulus
      of elasticity, with lower flexural modulus values compared to other groups. Also, result in
      smoother margins compared with other types of ceramic.

      So, present research will evaluate patient satisfaction, bonding properties and marginal
      adaptation
This study will carried out on patients collected from the dental clinics in fixed
      prosthodontics clinic, Faculty of Dentistry, Cairo University

      the visits will be designed as follows:

      .1st visit: (N.N) will call participants before tooth preparation procedure for X-ray
      reviewing and pre-operative photographing using a Professional digital camera also;
      Impression will be taken using the alginate impression material * for study cast analysis
      with suitable stock tray** size.

      Each participant will be asked to sign consent form written in patient native language.

      2nd visit: (Tooth preparation) After performing adequate disinfection and sterilization
      process for each instrument and tools will be used in this trial; the anesthetic solution
      (Anesthetic solution: Septanest SP, 4%, Septodont, France.) will be injected using
      infiltration technique. Then patients will be left from five to ten minutes then; the
      operator will check with the subjective for anasthesia.

      Full preparation will be carried out following the principles of Endocrown preparation with
      deep chamfer finish line while 2 observers will select visually the appropriate shade. Final
      vinylpolysiloxane impressions will be taken for each participant in each groupusing the
      suitable tray size.

      After final setting impressions will be checked for accuracy using magnifying loops
      (Magnifying loop: Univet optical technologies, Italy).

      Then protemp temporary endocrowns ) Temporary crown material: Structure, Voco, GMBH,
      Germany.( will be cemented using eugenol free (Temporary cement: RelyX Temp, USA).

      Impressions will be sent to the lab, poured with extra hard stone material. Then it will be
      removed from the impression after complete setting.

      Endorowns for each patient will be fabricated using either lithium di-silicate material
      (Emax) or Cerasmart blocks according to the random allocation of the patients

      3rd visit: Participants will be called again for final cementation. Temporary crown will be
      removed and abutments will be cleaned of any residues using pumice slurry ) Pumice slurry:
      DCL, Dental composite LTD, England.( applied with bristle brush and rubber cup under water
      irrigation.

      Proper isolation will be done before cementation then permanent dual cure resin cement
      (Permanent cement: Bifix-QM, Voco Gmbh, Germany ) will be used for luting of permanent crowns
      according to manufacturer instructions. Ask the patients to hold the crown under occlusal
      compression until luting cement polymerization. 5 minutes later, excess cement will be
      removed.

      Measuring of different outcomes will start in this visit for all patients.

      The following assessment surveys (clinical evaluations) will done for both groups:

      All patients will be recalled after 3, 6, 9, and 12 months. For each recall examination,
      evaluator will performed the direct clinical evaluation using modified USPHS criteria for
      margin integrity and gross fracture.

      Visual inspection will be used for gross fracture evaluation. Endorowns that intact and fully
      retained will be rated 'Alfa', Endocrowns with partially retained with some portion of the
      restoration still intact will be rated as 'Bravo'and endocrowns completely missing will be
      rated as 'Charlie'.

      Visual inspection and explorer will be using for marginal integrity evaluation. Endocrowns
      with no catch with The explorer and no visible crevice along the periphery of the restoration
      will be rated as Alpha (A), Endocrowns with explorer catches with visible evidence of a
      crevice, with and/or the base is not exposed, and the restoration is not mobile will be rated
      as Bravo (B) and endocrowms with explorer penetrates and extended to the dento-enamel
      junction will be rated as Charlie ©.

      In addition, questionnaires will be used to evaluate patients' satisfaction and potential
      postoperative discomfort as the following questions:

        1. Are you satisfied with your endocrown appearance?

        2. Are you satisfied with your endocrown shade?

        3. Do you feel your endocrown are poorly aligned?

        4. Do you feel your endocrown are protruding?

        5. Are you hiding your teeth while smiling?

      Adherence improvement session will be taking place in the initial visit. This session will
      include:

        -  Each patient will be informed about the study steps and maintain oral hygiene.
           Subsequent sessions will occur at the follow-up visits.

        -  The patients will be trained for tooth brushing, flossing and instructed all oral
           hygiene methods after each meal.

        -  Instruct the patients to record any abnormalities or mobility in endocrowns.

        -  Recall appointment will be performed every two months for aduration of one year to
           stress on oral hygiene.

        -  Data collection methods:

      Prosthodontic colleague will assess the outcome of each group. Data will be collected on
      excel sheets. All categorical data will be presented as risk ratios, while numerical data
      will be presented by mean and standard deviation. All data will be reported at a confidence
      interval of 95% and a p value of 5%.

      Each factor will be measured as explained in the outcome table. - Outcome results will be
      written down on the patients' folders by (NN), then will be given to (JG) for data
      management. All the information will be transferred on excel sheets and saved on a computer
      in safe place and locked with a password only known to JG. A copy of the data will be saved
      on a flash drive with JG to provide a back up for the data.

      Plans to increase participant retention & complete follow-up:

      Telephone numbers of each patients and address will be taken and included in study, then
      phone calls and messages will be sent to remind patients before each appointment.

      Data management:

      JG will enter all data electronically. Patient files are to stored in numerical order in a
      secured place. J.G and A.Z will have access to data

      Data Monitoring:

      AZ will be responsible of data monitoring if any lost or delete occurs, in that case: back up
      data will be taken from (J.G) to provide hard copy for the requested data and A.Z will make
      final decision.

      Harms:

      If 50% of the patients showed any unfavorable signs as sever pain, irreparable fracture or
      shade changes which might affect the results. Then the treatment will be considered as
      stopped guidelines which necessitate stopping the treatment and interim analysis will be
      performed.

      Auditing:

      Auditing of the study design will be done by (AZ).

      Ethics and dissemination Research ethics approval Protocol and informed consent form will be
      reviewed by the Ethics Committee of Scientific Research - faculty of Dentistry - Cairo
      University.

      Protocol amendments:

      Any changes in protocol affect the conduct of the study, benefit for patient or patient
      safety, including changes in study objectives, study design, sample size, study procedures,
      or significant administrative aspect will require formal amendment to the protocol. Such
      amendment will be agreed upon by the Council of Department of fixed prosthodontics, Faculty
      of Dentistry, Cairo University.

      Consent:

      Researcher will discuss the trial with all patients. Then patient can have an informed
      discussion with the researcher. Researcher will obtain written consent from patients willing
      to participate in the trial. All consent forms will write in Arabic language (Appendix 1.1).

      Confidentiality:

      All information related to study will store securely. All participants' information will
      store in locked cabinets in areas with limited access. To maintain participant
      confidentiality all data collection, process, and administrative forms will identify only by
      a coded ID number. All information related to patient names or other personal identifiers
      will store separately identified by code number. All local databases will be secured with
      password-protected access systems.

      Access to data:

      The investigator and supervisors will give access to the data sets. All data sets will be
      protected by password. To ensure confidentiality, Participant study information will become
      confidentially.

      Ancillary and post-trial care:

      All patients will be followed up 2 years even after the trial ends then might be used for
      further cohort study.

      Dissemination policy:

      o Study results will be published as partial fulfillment the Requirements for PHD degree in
      fixed prosthodontics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Gross Fracture
time frame: one year
description: Categorical Alpha (A): Restoration is intact and fully retained.
Bravo (B): Restoration is partially retained with some parts of the restoration still intact.
Charlie (C): Restoration is completely missing
measure: Patient satisfaction
time frame: one year
description: score by Visual Analogue Scale (VAS)
measure: Marginal Integrity
time frame: one year
description: Categorical Alpha (A): The explorer does not catch and no visible crevice along the periphery of the restoration.
Bravo (B): The explorer catches and with visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. Both dentin and/or the base is not exposed, and no mobility in the restoration.
Charlie ©: The explorer penetrates and extended to the dento-enamel junction.
arm group label: Emax CAD Endocrowns
arm group type: Active Comparator
description: Using lithium disilicate e.max restorations is documented in literature as a successful restoration. Two different ceramic crowns systems were investigated clinically for three-years and howed that patient was satisfied with the final restoration
arm group label: Cerasmart Endocrowns
arm group type: Experimental
description: A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) with high density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high strength and unique aesthetics. full homogeneous and even distribution nano ceramic network lead to unique physical properties for cerasmart . Uniform scuttle (very short inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™ with exceptional strength, retention, acceptable level of marginal adaptation
intervention type: Procedure
intervention name: CERASMART Endocrown
description: Endocrown fixed restoration used to restore endodontically treated anterior teeth using CERASMART blocks
arm group label: Cerasmart Endocrowns
intervention type: Procedure
intervention name: Emax Endocrown
description: Endocrown fixed restoration used to restore endodontically treated anterior teeth using Emax material
arm group label: Emax CAD Endocrowns
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Norhan Abd El Haliem, MDs
phone: 002
phone ext: 01007105072
email: norhan.naief@dentistry.cu.edu.eg
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Norhan Naief Abd El Haliem
investigator title: assistant lecturer
mesh term: Tooth, Nonvital
sharing ipd: No