xml: <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/NCT05973292</url>
    </required_header>
    <id_info>
      <org_study_id>M01160321</org_study_id>
      <nct_id>NCT05973292</nct_id>
    </id_info>
    <brief_title>Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations</brief_title>
    <official_title>Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kafrelsheikh University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kafrelsheikh 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>
        Rehabilitation of anterior endodontically treated teeth with significant coronal damage has&#xD;
        been problematic. Adopting endocrown design to treat teeth with this condition is still under&#xD;
        investigation. To address this issue, the USPHS criteria were adopted to assess the anterior&#xD;
        endocrown restorations manufactured using various ceramic materials and cemented with&#xD;
        different protocols.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        40 participants with anterior endodontically treated maxillary central incisors were enrolled&#xD;
        to restore their teeth with esthetic restorations Patients were divided into two groups,&#xD;
        zirconia and e-max groups. Each group was, further subdivided into two groups following the&#xD;
        cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical&#xD;
        marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and&#xD;
        18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction&#xD;
        and potential postoperative discomfort were also assessed and recorded during the same&#xD;
        periods. All qualitative data were displayed as frequency (N) and Percentages (%). The&#xD;
        chi-square test was utilized for qualitative data comparisons.&#xD;
  &#xD;
        Results:&#xD;
  &#xD;
        As to marginal integrity and patient satisfaction, no significant difference were revealed&#xD;
        regarding all scores at different intervals as P&gt;0.05.&#xD;
  &#xD;
        Conclusions:&#xD;
  &#xD;
        According to the findings of this study, ceramic endocrowns offer a promising restorative&#xD;
        solution for the rehabilitation of anterior endodontically treated teeth. Additionally,&#xD;
        regardless of the presence of the MDP monomer in its composition, using adhesive resin cement&#xD;
        achieved highly successful results when used with MDP-based ceramic primers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2021</start_date>
    <completion_date type="Actual">April 1, 2022</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
    <phase>Phase 2</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>All patients received their treatment at the same time. Follow-up periods were parallel for all participants.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Marginal Integrity</measure>
      <time_frame>3-6-9-12 Months</time_frame>
      <description>Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>3-6-9-12 Months</time_frame>
      <description>Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Endodontically Treated Teeth</condition>
    <condition>Anterior Teeth</condition>
    <arm_group>
      <arm_group_label>Group ZA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ggroup ZB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group EA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group EB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate</intervention_name>
      <description>Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max</description>
      <arm_group_label>Group EA</arm_group_label>
      <arm_group_label>Group ZA</arm_group_label>
      <other_name>Panavia SA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non MDP containg resin cement</intervention_name>
      <description>Adhesive resin cement not containing an MDP agent</description>
      <arm_group_label>Ggroup ZB</arm_group_label>
      <arm_group_label>Group EB</arm_group_label>
      <other_name>Duo-link Universal</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Freshly extracted teeth.&#xD;
  &#xD;
                 -  Completely formed apices&#xD;
  &#xD;
                 -  Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to&#xD;
                    the root apex.&#xD;
  &#xD;
                 -  Straight roots.&#xD;
  &#xD;
                 -  Teeth with single root canal.&#xD;
  &#xD;
                 -  Sound teeth with no cracks or fractured parts in its crown or root.&#xD;
  &#xD;
                 -  Absence of any carious lesions.&#xD;
  &#xD;
                 -  No signs of internal or external root resorption.&#xD;
  &#xD;
                 -  Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a&#xD;
                    digital caliper.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Previously endodontically treated teeth.&#xD;
  &#xD;
                 -  Markedly curved roots.&#xD;
  &#xD;
                 -  Root contains more than one canal.&#xD;
  &#xD;
                 -  Presence of canal calcifications or pulp stones.&#xD;
  &#xD;
                 -  Internal or external root resorption.&#xD;
  &#xD;
                 -  Presence of cracks, fractures or caries.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lamia Dawood, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Dentistry,Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>33516</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
      <investigator_full_name>Nehal Samra</investigator_full_name>
      <investigator_title>Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry</investigator_title>
    </responsible_party>
    <keyword>Digital Dentistry, E-max, MDP, Zirconia</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>
  
  
text: 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/NCT05973292
  org study id: M01160321
  nct id: NCT05973292
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rehabilitation of anterior endodontically treated teeth with significant coronal damage has
        been problematic. Adopting endocrown design to treat teeth with this condition is still under
        investigation. To address this issue, the USPHS criteria were adopted to assess the anterior
        endocrown restorations manufactured using various ceramic materials and cemented with
        different protocols.
  40 participants with anterior endodontically treated maxillary central incisors were enrolled
        to restore their teeth with esthetic restorations Patients were divided into two groups,
        zirconia and e-max groups. Each group was, further subdivided into two groups following the
        cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical
        marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and
        18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction
        and potential postoperative discomfort were also assessed and recorded during the same
        periods. All qualitative data were displayed as frequency (N) and Percentages (%). The
        chi-square test was utilized for qualitative data comparisons.
  
        Results:
  
        As to marginal integrity and patient satisfaction, no significant difference were revealed
        regarding all scores at different intervals as P>0.05.
  
        Conclusions:
  
        According to the findings of this study, ceramic endocrowns offer a promising restorative
        solution for the rehabilitation of anterior endodontically treated teeth. Additionally,
        regardless of the presence of the MDP monomer in its composition, using adhesive resin cement
        achieved highly successful results when used with MDP-based ceramic primers.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The outcome assessors and participants were blinded throughout the whole procedure. The dentist practitioner was responsible for all clinical procedures.
  measure: Marginal Integrity
  time frame: 3-6-9-12 Months
  description: Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria
  measure: Patient Satisfaction
  time frame: 3-6-9-12 Months
  description: Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria
  arm group label: Group ZA
  arm group type: Experimental
  description: Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
  arm group label: Ggroup ZB
  arm group type: Experimental
  description: Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
  arm group label: Group EA
  arm group type: Experimental
  description: Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement.
  arm group label: Group EB
  arm group type: Experimental
  description: Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement.
  intervention type: Other
  intervention name: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate
  description: Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
  arm group label: Group EA
  arm group label: Group ZA
  other name: Panavia SA
  intervention type: Other
  intervention name: Non MDP containg resin cement
  description: Adhesive resin cement not containing an MDP agent
  arm group label: Ggroup ZB
  arm group label: Group EB
  other name: Duo-link Universal
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lamia Dawood, Professor
  role: Study Director
  affiliation: Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Kafrelsheikh University
  investigator full name: Nehal Samra
  investigator title: Assistant Lecturer- Prosthodontic Department- Faculty of Dentistry
  mesh term: Tooth, Nonvital