<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/NCT03032978</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-01-06</org_study_id>
    <nct_id>NCT03032978</nct_id>
  </id_info>
  <brief_title>Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment</brief_title>
  <official_title>Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: 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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in&#xD;
      two-step indirect pulp treatment: Randomized clinical trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2018</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain: VAS</measure>
    <time_frame>6 month</time_frame>
    <description>post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Deep Caries</condition>
  <arm_group>
    <arm_group_label>Calcium silicate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calcium hydroxide</intervention_name>
    <description>Pulp capping material</description>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <other_name>Dycal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calcium silicate</intervention_name>
    <description>Pulp capping material</description>
    <arm_group_label>Calcium silicate</arm_group_label>
    <other_name>Theracal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-50 years.&#xD;
&#xD;
          -  Males or females.&#xD;
&#xD;
          -  Co-operative patients approving to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 19 years old or older than 50 years old.&#xD;
&#xD;
          -  Disabilities.&#xD;
&#xD;
          -  Systemic diseases or severe medically compromised.&#xD;
&#xD;
          -  Lack of compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ehsan Hossam</name>
      <address>
        <city>Cairo</city>
        <state>Giza Governorate</state>
        <zip>12345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>ehsan hossam</investigator_full_name>
    <investigator_title>Assistant lecturer conservative dentistry - Ahram canadian university</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT03032978
org study id: CEBD-CU-2017-01-06
nct id: NCT03032978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in
      two-step indirect pulp treatment: Randomized clinical trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Pain: VAS
time frame: 6 month
description: post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain
arm group label: Calcium silicate
arm group type: Experimental
description: intervention
arm group label: Calcium Hydroxide
arm group type: Active Comparator
description: Comparator
intervention type: Other
intervention name: Calcium hydroxide
description: Pulp capping material
arm group label: Calcium Hydroxide
other name: Dycal
intervention type: Other
intervention name: Calcium silicate
description: Pulp capping material
arm group label: Calcium silicate
other name: Theracal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: ehsan hossam
investigator title: Assistant lecturer conservative dentistry - Ahram canadian university
mesh term: Calcium, Dietary
mesh term: Calcium
sharing ipd: Undecided