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/NCT06020911</url>
    </required_header>
    <id_info>
      <org_study_id>R-PED-6-21-6</org_study_id>
      <nct_id>NCT06020911</nct_id>
    </id_info>
    <brief_title>Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars</brief_title>
    <official_title>Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta 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>
        this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed&#xD;
        after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of&#xD;
        the study is that there will be no difference in the quantity and quality of reparative&#xD;
        dentin formation between the tested materials used for the indirect pulp capping&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp&#xD;
        capping material is to be successful when it is biocompatible, radiopaque, maintain good&#xD;
        seal, protect the pulp against bacterial invasion in both long and short run, release&#xD;
        sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate&#xD;
        reparative dentin formation through inducing the pulp cells to form odontoblasts.&#xD;
  &#xD;
        Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an&#xD;
        indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate&#xD;
        or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed&#xD;
        better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Thickness of dentin in mm</measure>
      <time_frame>UP to 9 months postoperatively</time_frame>
      <description>Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiodenisty in Hounsfield units</measure>
      <time_frame>UP to 9 months postoperatively</time_frame>
      <description>Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>pulp vitality</measure>
      <time_frame>UP to 9 months postoperatively</time_frame>
      <description>The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">17</enrollment>
    <condition>Pulp Caping</condition>
    <condition>Biodentine</condition>
    <condition>Theracal</condition>
    <arm_group>
      <arm_group_label>Biodentine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>17 primary second molars of 17 children will be capped with Biodentine.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Theracal light cured</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>17 primary second molars of 17 children will be capped with Theracal light cured</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Biodentine</intervention_name>
      <description>17 primary second molars of 17 children will be capped with Biodentine</description>
      <arm_group_label>Biodentine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Theracal light cured</intervention_name>
      <description>17 primary second molars of 17 children will be capped with Theracal light cured</description>
      <arm_group_label>Theracal light cured</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Each child has bilateral vital cavitated carious lesions in primary molars.&#xD;
  &#xD;
            2. Positive vital pulp testing for both hot and cold response; is determined by ethyl&#xD;
               chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused&#xD;
               by these tests should not persist after the stimulus is removed.&#xD;
  &#xD;
            3. Patient and parent cooperation.&#xD;
  &#xD;
            4. Accessible isolation for the operated tooth with rubber dam.&#xD;
  &#xD;
            5. primary molars with cavitated carious lesion on either occlusal or proximal surface&#xD;
               that extend into the dentin .&#xD;
  &#xD;
            6. Availability of remaining dentin thickness over the pulp.&#xD;
  &#xD;
            7. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root&#xD;
               resorption.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Spontaneous pain, or persistent swelling or fistula.&#xD;
  &#xD;
            2. Pain with percussion, presence of abscess and pathological mobility.&#xD;
  &#xD;
            3. Uncooperative patient.&#xD;
  &#xD;
            4. Progression of caries lesion to pulp and pulp exposure.&#xD;
  &#xD;
            5. Presence of periapical lesion as abscess, cyst or granuloma.&#xD;
  &#xD;
            6. Unhealthy bony tissues.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-garbia</state>
          <zip>139</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Alaa A Abd Elghany, MBBCh</last_name>
        <phone>002 01551100960</phone>
        <phone_ext>139</phone_ext>
        <email>Pearlagh@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Alaa Abd Elhameed Abd Elghany</investigator_full_name>
      <investigator_title>Principle investigator Alaa Abd Elhameed Abd Elghany</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06020911
  org study id: R-PED-6-21-6
  nct id: NCT06020911
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed
        after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of
        the study is that there will be no difference in the quantity and quality of reparative
        dentin formation between the tested materials used for the indirect pulp capping
  Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp
        capping material is to be successful when it is biocompatible, radiopaque, maintain good
        seal, protect the pulp against bacterial invasion in both long and short run, release
        sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate
        reparative dentin formation through inducing the pulp cells to form odontoblasts.
  
        Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an
        indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate
        or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed
        better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Thickness of dentin in mm
  time frame: UP to 9 months postoperatively
  description: Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm
  measure: Radiodenisty in Hounsfield units
  time frame: UP to 9 months postoperatively
  description: Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units
  measure: pulp vitality
  time frame: UP to 9 months postoperatively
  description: The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact
  arm group label: Biodentine
  arm group type: Active Comparator
  description: 17 primary second molars of 17 children will be capped with Biodentine.
  arm group label: Theracal light cured
  arm group type: Active Comparator
  description: 17 primary second molars of 17 children will be capped with Theracal light cured
  intervention type: Drug
  intervention name: Biodentine
  description: 17 primary second molars of 17 children will be capped with Biodentine
  arm group label: Biodentine
  intervention type: Drug
  intervention name: Theracal light cured
  description: 17 primary second molars of 17 children will be capped with Theracal light cured
  arm group label: Theracal light cured
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 7 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Alaa Abd Elhameed Abd Elghany
  investigator title: Principle investigator Alaa Abd Elhameed Abd Elghany
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author