<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/NCT04479046</url>
  </required_header>
  <id_info>
    <org_study_id>NAP202</org_study_id>
    <nct_id>NCT04479046</nct_id>
  </id_info>
  <brief_title>Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns</brief_title>
  <official_title>Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Evaluation of PMMA pediatric crowns&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:&#xD;
&#xD;
      I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to&#xD;
      zirconia crowns and stainless steel crowns after 6 months, and 12 months.&#xD;
&#xD;
      II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.&#xD;
&#xD;
      III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's&#xD;
      satisfaction regarding the appearance and clinical performance of PMMA crowns when compared&#xD;
      to stainless steel crowns and zirconia crowns through a given questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gingival health</measure>
    <time_frame>6 months</time_frame>
    <description>Plaque index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Crown survival</measure>
    <time_frame>6 months</time_frame>
    <description>Fracture</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Decay, Dental</condition>
  <arm_group>
    <arm_group_label>Stainless steel crowns</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3M ESPE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zirconia crowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nu Smile</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PMMA crowns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dental Direkt</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PMMA crowns</intervention_name>
    <description>New type of pediatric crowns</description>
    <arm_group_label>PMMA crowns</arm_group_label>
    <arm_group_label>Stainless steel crowns</arm_group_label>
    <arm_group_label>Zirconia crowns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children included in the study should conform to the following criteria:&#xD;
&#xD;
               1. Aged 5-8 years old&#xD;
&#xD;
               2. Medically free&#xD;
&#xD;
               3. Patient should suffer from extensively decayed primary lower second molar that&#xD;
                  will undergo pulpotomy.&#xD;
&#xD;
               4. The anticipated exfoliation date of the selected primary teeth has to be more&#xD;
                  than 12 months from the date of the study start.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
                  Children with the following criteria will be totally excluded from the study:&#xD;
&#xD;
               1. Children who are extremely uncooperative and difficult to manage.&#xD;
&#xD;
               2. Children suffering from any medical conditions that can't be managed in the&#xD;
                  clinic.&#xD;
&#xD;
               3. Teeth with decay extending beneath the free gingival margin.&#xD;
&#xD;
               4. Teeth that were grossly broken down, that cannot be restored.&#xD;
&#xD;
               5. Presence of uncontrolled bleeding.&#xD;
&#xD;
               6. Clinical or radiographic evidence of non-vitality such as presence of an abscess&#xD;
                  or a sinus, obvious discoloration, and premature hypermobility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry, Ain Shams University</name>
      <address>
        <city>Heliopolis</city>
        <state>Cairo</state>
        <zip>11737</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 27, 2019</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Nada Aboushady</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</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/NCT04479046
org study id: NAP202
nct id: NCT04479046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of PMMA pediatric crowns
The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

      I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to
      zirconia crowns and stainless steel crowns after 6 months, and 12 months.

      II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

      III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's
      satisfaction regarding the appearance and clinical performance of PMMA crowns when compared
      to stainless steel crowns and zirconia crowns through a given questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gingival health
time frame: 6 months
description: Plaque index
measure: Crown survival
time frame: 6 months
description: Fracture
arm group label: Stainless steel crowns
arm group type: Active Comparator
description: 3M ESPE
arm group label: Zirconia crowns
arm group type: Experimental
description: Nu Smile
arm group label: PMMA crowns
arm group type: Experimental
description: Dental Direkt
intervention type: Other
intervention name: PMMA crowns
description: New type of pediatric crowns
arm group label: PMMA crowns
arm group label: Stainless steel crowns
arm group label: Zirconia crowns
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Nada Aboushady
investigator title: Assistant Lecturer
mesh term: Dental Caries
sharing ipd: Undecided