<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/NCT03285022</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-17</org_study_id>
    <nct_id>NCT03285022</nct_id>
  </id_info>
  <brief_title>Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial</brief_title>
  <official_title>Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled 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>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>
      The study aim to evaluate the difference between the effect of zinc modified glass ionomer&#xD;
      and conventional glass ionomer on the success of partial caries removel technique&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The zinc ion has an antibacterial effect which could increase the success of partial caries&#xD;
      removel technique by decreasing the bactrial population .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 20, 2017</start_date>
  <completion_date type="Anticipated">April 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 20, 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>Outcome assessor and participant will be blinded to the type of material</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Digital radigraphic assessment</measure>
    <time_frame>At baseline ,3months and 6 months</time_frame>
    <description>The presence of periapical change or change in lamina dura change after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post opreative hypersenstivity</measure>
    <time_frame>Baseline ,at 3 months and at 6 months</time_frame>
    <description>The presence or absence of pain with thermal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Carious Dentin</condition>
  <arm_group>
    <arm_group_label>Zinc modified glass ionomer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventionel glass ionomer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial caries removel techniques</intervention_name>
    <description>Removel of all superfacial dentin and leaving the inner affectted dentin</description>
    <arm_group_label>Conventionel glass ionomer</arm_group_label>
    <arm_group_label>Zinc modified glass ionomer</arm_group_label>
    <other_name>Partial caries removel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female (&gt;18 y)&#xD;
&#xD;
          2. patient with At least 1 deep carious lesion&#xD;
&#xD;
          3. Clinical symptoms of reversible pulpitis with positive pulp response&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting&#xD;
             for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion&#xD;
             (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used&#xD;
             for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6.&#xD;
             Patients unable to give consent(mentally retarted, or refuse to right a consent)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dina Mounir Elkady, Assitant lecturer</last_name>
    <phone>01004297317</phone>
    <email>Dina.elkady@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Riad Farid, Professor</last_name>
    <phone>01223113166</phone>
    <email>mriad_52@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dina mounir elkady</investigator_full_name>
    <investigator_title>Assisstant lecturer</investigator_title>
  </responsible_party>
  <keyword>Incomplete caries removel</keyword>
  <keyword>Partial caries removel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT03285022
org study id: CEBD-CU-2017-09-17
nct id: NCT03285022
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aim to evaluate the difference between the effect of zinc modified glass ionomer
      and conventional glass ionomer on the success of partial caries removel technique
The zinc ion has an antibacterial effect which could increase the success of partial caries
      removel technique by decreasing the bactrial population .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Outcome assessor and participant will be blinded to the type of material
measure: Digital radigraphic assessment
time frame: At baseline ,3months and 6 months
description: The presence of periapical change or change in lamina dura change after the procedure
measure: Post opreative hypersenstivity
time frame: Baseline ,at 3 months and at 6 months
description: The presence or absence of pain with thermal
arm group label: Zinc modified glass ionomer
arm group type: Experimental
description: Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel
arm group label: Conventionel glass ionomer
arm group type: Active Comparator
description: Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel
intervention type: Procedure
intervention name: Partial caries removel techniques
description: Removel of all superfacial dentin and leaving the inner affectted dentin
arm group label: Conventionel glass ionomer
arm group label: Zinc modified glass ionomer
other name: Partial caries removel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dina Mounir Elkady, Assitant lecturer
phone: 01004297317
email: Dina.elkady@dentistry.cu.edu.eg
last name: Mohamed Riad Farid, Professor
phone: 01223113166
email: mriad_52@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dina mounir elkady
investigator title: Assisstant lecturer
mesh term: Dental Caries
mesh term: Hypersensitivity
sharing ipd: No