<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/NCT03791255</url>
  </required_header>
  <id_info>
    <org_study_id>Indirect pulp primary molars</org_study_id>
    <nct_id>NCT03791255</nct_id>
  </id_info>
  <brief_title>Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars</brief_title>
  <official_title>Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to explore if light cured resin modified Calcium silicate&#xD;
      could result in better clinical and radiographic success if compared to light cured Calcium&#xD;
      hydroxide when used in indirect pulp capping treatment in primary molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate clinical and radiographic success of resin modified calcium silicate in&#xD;
      comparison to light cured calcium hydroxide as indirect pulp capping materials in primary&#xD;
      molars.&#xD;
&#xD;
      P: Children aged (4-7 years) with deep carious lesions in lower primary second molars&#xD;
      indicated for indirect pulp treatment.&#xD;
&#xD;
      I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).&#xD;
&#xD;
      C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic&#xD;
      success.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>1 month</time_frame>
    <description>Pain questionnaire (binary yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>3 months</time_frame>
    <description>Pain questionnaire (binary yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>6 months</time_frame>
    <description>Pain questionnaire (binary yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>12 months</time_frame>
    <description>Pain questionnaire (binary yes/no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>1 month</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>3 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>6 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>12 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus or fistula</measure>
    <time_frame>1 month</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus or fistula</measure>
    <time_frame>3 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus or fistula</measure>
    <time_frame>6 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus or fistula</measure>
    <time_frame>12 months</time_frame>
    <description>Visual examination by the operator (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth mobility</measure>
    <time_frame>1 month</time_frame>
    <description>back of the mirror to check mobility (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth mobility</measure>
    <time_frame>3 months</time_frame>
    <description>back of the mirror to check mobility (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth mobility</measure>
    <time_frame>6 months</time_frame>
    <description>back of the mirror to check mobility (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth mobility</measure>
    <time_frame>12 months</time_frame>
    <description>back of the mirror to check mobility (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on percussion</measure>
    <time_frame>1 month</time_frame>
    <description>back of the mirror to check pain on percussion (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on percussion</measure>
    <time_frame>3 months</time_frame>
    <description>back of the mirror to check pain on percussion (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on percussion</measure>
    <time_frame>6 months</time_frame>
    <description>back of the mirror to check pain on percussion (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on percussion</measure>
    <time_frame>12 months</time_frame>
    <description>back of the mirror to check pain on percussion (binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of radiolucent lesions at furcation or periapical region</measure>
    <time_frame>1 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of radiolucent lesions at furcation or periapical region</measure>
    <time_frame>3 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of radiolucent lesions at furcation or periapical region</measure>
    <time_frame>6 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of radiolucent lesions at furcation or periapical region</measure>
    <time_frame>12 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>widening in the periodontal membrane space</measure>
    <time_frame>1 month</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>widening in the periodontal membrane space</measure>
    <time_frame>3 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>widening in the periodontal membrane space</measure>
    <time_frame>6 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>widening in the periodontal membrane space</measure>
    <time_frame>12 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of internal or external root resorption</measure>
    <time_frame>1 month</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of internal or external root resorption</measure>
    <time_frame>3 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of internal or external root resorption</measure>
    <time_frame>6 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of internal or external root resorption</measure>
    <time_frame>12 months</time_frame>
    <description>(binary yes/no)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Deep Carious Lesion</condition>
  <condition>Indirect Pulp Treatment</condition>
  <arm_group>
    <arm_group_label>Resin Modified Calcium Silicate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Light Cured Calcium Hydroxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium silicate liner</intervention_name>
    <description>new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping</description>
    <arm_group_label>Resin Modified Calcium Silicate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium hydroxide liner</intervention_name>
    <description>Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge</description>
    <arm_group_label>Light Cured Calcium Hydroxide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically free children.&#xD;
&#xD;
          2. Age range from 4-7 years.&#xD;
&#xD;
          3. Presence of lower second primary molars with deep carious occlusal lesion.&#xD;
&#xD;
          4. No history of spontaneous pain (reversible pulpitis).&#xD;
&#xD;
          5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth&#xD;
             mobility.&#xD;
&#xD;
          6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and&#xD;
             absence of internal or external root resorption.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncooperative children.&#xD;
&#xD;
          2. Any unmet previous criterion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yasmine Ashraf Elbanna</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>resin modified calcium silicate</keyword>
  <keyword>indirect pulp treatment</keyword>
  <keyword>primary molars</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <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>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/NCT03791255
org study id: Indirect pulp primary molars
nct id: NCT03791255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to explore if light cured resin modified Calcium silicate
      could result in better clinical and radiographic success if compared to light cured Calcium
      hydroxide when used in indirect pulp capping treatment in primary molars.
To evaluate clinical and radiographic success of resin modified calcium silicate in
      comparison to light cured calcium hydroxide as indirect pulp capping materials in primary
      molars.

      P: Children aged (4-7 years) with deep carious lesions in lower primary second molars
      indicated for indirect pulp treatment.

      I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).

      C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic
      success.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative pain
time frame: 1 month
description: Pain questionnaire (binary yes/no)
measure: Postoperative pain
time frame: 3 months
description: Pain questionnaire (binary yes/no)
measure: Postoperative pain
time frame: 6 months
description: Pain questionnaire (binary yes/no)
measure: Postoperative pain
time frame: 12 months
description: Pain questionnaire (binary yes/no)
measure: Swelling
time frame: 1 month
description: Visual examination by the operator (binary yes/no)
measure: Swelling
time frame: 3 months
description: Visual examination by the operator (binary yes/no)
measure: Swelling
time frame: 6 months
description: Visual examination by the operator (binary yes/no)
measure: Swelling
time frame: 12 months
description: Visual examination by the operator (binary yes/no)
measure: Sinus or fistula
time frame: 1 month
description: Visual examination by the operator (binary yes/no)
measure: Sinus or fistula
time frame: 3 months
description: Visual examination by the operator (binary yes/no)
measure: Sinus or fistula
time frame: 6 months
description: Visual examination by the operator (binary yes/no)
measure: Sinus or fistula
time frame: 12 months
description: Visual examination by the operator (binary yes/no)
measure: Tooth mobility
time frame: 1 month
description: back of the mirror to check mobility (binary yes/no)
measure: Tooth mobility
time frame: 3 months
description: back of the mirror to check mobility (binary yes/no)
measure: Tooth mobility
time frame: 6 months
description: back of the mirror to check mobility (binary yes/no)
measure: Tooth mobility
time frame: 12 months
description: back of the mirror to check mobility (binary yes/no)
measure: pain on percussion
time frame: 1 month
description: back of the mirror to check pain on percussion (binary yes/no)
measure: pain on percussion
time frame: 3 months
description: back of the mirror to check pain on percussion (binary yes/no)
measure: pain on percussion
time frame: 6 months
description: back of the mirror to check pain on percussion (binary yes/no)
measure: pain on percussion
time frame: 12 months
description: back of the mirror to check pain on percussion (binary yes/no)
measure: Occurrence of radiolucent lesions at furcation or periapical region
time frame: 1 months
description: (binary yes/no)
measure: Occurrence of radiolucent lesions at furcation or periapical region
time frame: 3 months
description: (binary yes/no)
measure: Occurrence of radiolucent lesions at furcation or periapical region
time frame: 6 months
description: (binary yes/no)
measure: Occurrence of radiolucent lesions at furcation or periapical region
time frame: 12 months
description: (binary yes/no)
measure: widening in the periodontal membrane space
time frame: 1 month
description: (binary yes/no)
measure: widening in the periodontal membrane space
time frame: 3 months
description: (binary yes/no)
measure: widening in the periodontal membrane space
time frame: 6 months
description: (binary yes/no)
measure: widening in the periodontal membrane space
time frame: 12 months
description: (binary yes/no)
measure: presence of internal or external root resorption
time frame: 1 month
description: (binary yes/no)
measure: presence of internal or external root resorption
time frame: 3 months
description: (binary yes/no)
measure: presence of internal or external root resorption
time frame: 6 months
description: (binary yes/no)
measure: presence of internal or external root resorption
time frame: 12 months
description: (binary yes/no)
arm group label: Resin Modified Calcium Silicate
arm group type: Experimental
description: light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
arm group label: Light Cured Calcium Hydroxide
arm group type: Active Comparator
description: gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
intervention type: Drug
intervention name: Calcium silicate liner
description: new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
arm group label: Resin Modified Calcium Silicate
intervention type: Drug
intervention name: Calcium hydroxide liner
description: Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge
arm group label: Light Cured Calcium Hydroxide
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yasmine Ashraf Elbanna
investigator title: Assistant lecturer
mesh term: Dental Caries
mesh term: Calcium, Dietary
mesh term: Calcium
sharing ipd: No