<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/NCT03233893</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-07-21</org_study_id>
    <nct_id>NCT03233893</nct_id>
  </id_info>
  <brief_title>Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries</brief_title>
  <official_title>Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Light Activated Calcium Hydroxide in Management of Simple Deeply Seated Carious Lesions With Partial Caries Removal</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>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>
      sixty participants will be divided in to two groups (n=30) of patient treated by partial&#xD;
      caries removal according to the capping material (A),where (A1)represents calcium silicate&#xD;
      group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group&#xD;
      (A1) in deep occlusal caries and taking the base line image after restoring the cavity with&#xD;
      composite restoration and apply light activated calcium hydroxide for(A2)group in deep&#xD;
      occlusal caries and taking the base line image after restoring with composite&#xD;
      restoration.Take follow up image after one year to measure the calcific bridge formation for&#xD;
      both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Management of deep carious lesion may constitute a real challenge for the operator.The basic&#xD;
      idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide&#xD;
      has been the gold standard as a capping material but there are some drawbacks like&#xD;
      solubility,gaps formation and mechanical instability so a need for a capping material such as&#xD;
      calcium silicate has shown several advantages.&#xD;
&#xD;
      Sixty participants will be divided in to two groups (n=30) of patient treated by partial&#xD;
      caries removal.The first group(A1) will be treated by light activated calcium silicate and&#xD;
      the second group(A2) will be treated by light activated calcium hydroxide after partial&#xD;
      caries removal of deep occlusal caries then restore by composite restoration.Paralleling&#xD;
      technique using film holders and custom made bite blocks will be used to standardize the&#xD;
      serial radiographs and to prevent the distortion of the radiographic image.An increase in&#xD;
      dentin thickness will be measured through sequential imaging by soft ware named Digora&#xD;
      (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the&#xD;
      scanned image.All images will be studied carefully for an increase in dentin thickness&#xD;
      keeping the reference point constant from the furcation area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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 (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient and the outcome assessor will be blinded in this study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>calcific bridge formation will be measured by digora software</measure>
    <time_frame>1 year</time_frame>
    <description>in millimeters</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Deep Carious Lesions</condition>
  <arm_group>
    <arm_group_label>light activated calcium silicate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>light activated calcium hydroxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>light activated calcium silicate</intervention_name>
    <description>for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.&#xD;
for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.</description>
    <arm_group_label>light activated calcium hydroxide</arm_group_label>
    <arm_group_label>light activated calcium silicate</arm_group_label>
    <other_name>light activated calcium hydroxide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal adults will be recruited in this study ,all the volunteers participated in this&#xD;
             experiment will be healthy looking free medical history.&#xD;
&#xD;
          -  Patients have simple deep carious lesions in his /her mouth with no pain or history of&#xD;
             sensitivity to cold which disappear immediately after removal of the stimulus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically compromised patients and teeth with history of spontaneous pain or&#xD;
             tenderness to percussion were excluded from the study.&#xD;
&#xD;
          -  Pregnant females will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>basma gamal hassan, master</last_name>
    <phone>01011137104</phone>
    <email>basmadental1@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>basma gamal hassan, master</last_name>
    <phone>01011137104</phone>
    <email>basmadental1@gmail.om</email>
  </overall_contact_backup>
  <link>
    <url>http://www.contempclindent.org</url>
    <description>comparative evaluation of calcium silicate -based dentin substitute (Biodentine) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth</description>
  </link>
  <results_reference>
    <citation>Grewal N, Salhan R, Kaur N, Patel HB. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine(R)) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):457-463. doi: 10.4103/0976-237X.194116.</citation>
    <PMID>27994411</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>basma gamal hassan</investigator_full_name>
    <investigator_title>Resident of conservative department ,faculty of oral and dental medicine</investigator_title>
  </responsible_party>
  <keyword>based dentin substitute</keyword>
  <keyword>dentin bridge</keyword>
  <keyword>tertiary dentin</keyword>
  <keyword>indirect pulp treatment</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/NCT03233893
org study id: CEBC-CU-2017-07-21
nct id: NCT03233893
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
sixty participants will be divided in to two groups (n=30) of patient treated by partial
      caries removal according to the capping material (A),where (A1)represents calcium silicate
      group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group
      (A1) in deep occlusal caries and taking the base line image after restoring the cavity with
      composite restoration and apply light activated calcium hydroxide for(A2)group in deep
      occlusal caries and taking the base line image after restoring with composite
      restoration.Take follow up image after one year to measure the calcific bridge formation for
      both groups.
Management of deep carious lesion may constitute a real challenge for the operator.The basic
      idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide
      has been the gold standard as a capping material but there are some drawbacks like
      solubility,gaps formation and mechanical instability so a need for a capping material such as
      calcium silicate has shown several advantages.

      Sixty participants will be divided in to two groups (n=30) of patient treated by partial
      caries removal.The first group(A1) will be treated by light activated calcium silicate and
      the second group(A2) will be treated by light activated calcium hydroxide after partial
      caries removal of deep occlusal caries then restore by composite restoration.Paralleling
      technique using film holders and custom made bite blocks will be used to standardize the
      serial radiographs and to prevent the distortion of the radiographic image.An increase in
      dentin thickness will be measured through sequential imaging by soft ware named Digora
      (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the
      scanned image.All images will be studied carefully for an increase in dentin thickness
      keeping the reference point constant from the furcation area.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The patient and the outcome assessor will be blinded in this study
measure: calcific bridge formation will be measured by digora software
time frame: 1 year
description: in millimeters
arm group label: light activated calcium silicate
arm group type: Experimental
description: Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
arm group label: light activated calcium hydroxide
arm group type: Active Comparator
description: Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
intervention type: Other
intervention name: light activated calcium silicate
description: for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.
for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.
arm group label: light activated calcium hydroxide
arm group label: light activated calcium silicate
other name: light activated calcium hydroxide
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: basma gamal hassan, master
phone: 01011137104
email: basmadental1@gmail.com
last name: basma gamal hassan, master
phone: 01011137104
email: basmadental1@gmail.om
url: http://www.contempclindent.org
description: comparative evaluation of calcium silicate -based dentin substitute (Biodentine) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth
citation: Grewal N, Salhan R, Kaur N, Patel HB. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine(R)) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):457-463. doi: 10.4103/0976-237X.194116.
PMID: 27994411
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: basma gamal hassan
investigator title: Resident of conservative department ,faculty of oral and dental medicine
mesh term: Dental Caries
mesh term: Calcium, Dietary
mesh term: Calcium
sharing ipd: No