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/NCT05970536</url>
    </required_header>
    <id_info>
      <org_study_id>341122</org_study_id>
      <nct_id>NCT05970536</nct_id>
    </id_info>
    <brief_title>Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material</brief_title>
    <official_title>The Effect of Two Different Contemporary Chelating Agents on Vital Pulp Therapy in Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sinai University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sinai University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial is designed to study and compare the effect of two different types of&#xD;
        chelating agents on the vital pulp therapy of mature permanent teeth with irreversible&#xD;
        pulpitis using bioceramic material.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. The vital pulps exposed by caries process is treated by complete caries removal followed&#xD;
             by full pulpotomy.&#xD;
  &#xD;
          2. After hemostasis, application of apple vinegar and EDTA 17% will be used followed by MTA&#xD;
             application. finally teeth will be restored with resin composite restoration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <intervention_model_description>Parallel double blinded.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>double ( participant, outcome assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.</measure>
      <time_frame>one year</time_frame>
      <description>Through post operative pain assessment using Visual analogue scale (0-3) scores as 0 represents no pain, 1= mild pain, 2= moderate pain and 3= sever pain. VAS scores marked at intervals of 2,6,24,48 and 72 hours.&#xD;
  Clinical success criteria:&#xD;
  Clinical parameters indicating successful treatment include the following criteria:&#xD;
  Absence of pain except for the first 24 hours.&#xD;
  Normal soft tissue around the tooth ( no swelling, no sinus tract).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Pulp vitality</measure>
      <time_frame>one year</time_frame>
      <description>Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiographic success</measure>
      <time_frame>one year</time_frame>
      <description>Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:&#xD;
  No periapical pathosis.&#xD;
  No radicular resorption defects.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Vital Pulp Therapy</condition>
    <arm_group>
      <arm_group_label>Apple vinegar group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After hemostasis of the exposed pulp is achieved, Apple vinegar will be used for dentin conditioning for 5 mins then 1-2 mm thickness of MTA placed on the exposed pulp chamber.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EDTA 17% group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After hemostasis of the exposed pulp is achieved, EDTA 17 % will be used for dentin conditioning then 1-2 mm thickness of MTA placed on the exposed pulp chamber.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Apple vinegar or EDTA 17%</intervention_name>
      <description>Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.</description>
      <arm_group_label>Apple vinegar group</arm_group_label>
      <arm_group_label>EDTA 17% group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of at least one tooth with carious pulp exposure and irreversible pulpitis.&#xD;
  &#xD;
            -  Cooperative behavior with no medical problem.&#xD;
  &#xD;
            -  Absence of tooth mobility , tenderness on percussion.&#xD;
  &#xD;
            -  History of pain with cold and sweets.&#xD;
  &#xD;
            -  Radiographically, no internal or external resorption, no periapical or furcation&#xD;
               radiolucency and no widening of the periodontal membrane space.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth with pulp necrosis.&#xD;
  &#xD;
            -  Presence of sinus tract.&#xD;
  &#xD;
            -  Teeth with open apices.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  History of intolerance of non- steroidal anti inflammatory drugs.&#xD;
  &#xD;
            -  Tenderness to palpation of adjacent soft tissues&#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>
    <overall_official>
      <last_name>Mona R Abo El Wafa Ahmed, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry, Sinai University.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mona Rizk Abo El Wafa Ahmed</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sinai University</investigator_affiliation>
      <investigator_full_name>Mona Rizk Abo El Wafa Ahmed</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulpitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>2 years</ipd_time_frame>
    </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/NCT05970536
  org study id: 341122
  nct id: NCT05970536
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial is designed to study and compare the effect of two different types of
        chelating agents on the vital pulp therapy of mature permanent teeth with irreversible
        pulpitis using bioceramic material.
  1. The vital pulps exposed by caries process is treated by complete caries removal followed
             by full pulpotomy.
  
          2. After hemostasis, application of apple vinegar and EDTA 17% will be used followed by MTA
             application. finally teeth will be restored with resin composite restoration.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel double blinded.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: double ( participant, outcome assessor)
  measure: Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.
  time frame: one year
  description: Through post operative pain assessment using Visual analogue scale (0-3) scores as 0 represents no pain, 1= mild pain, 2= moderate pain and 3= sever pain. VAS scores marked at intervals of 2,6,24,48 and 72 hours.
  Clinical success criteria:
  Clinical parameters indicating successful treatment include the following criteria:
  Absence of pain except for the first 24 hours.
  Normal soft tissue around the tooth ( no swelling, no sinus tract).
  measure: The Pulp vitality
  time frame: one year
  description: Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months
  measure: Radiographic success
  time frame: one year
  description: Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:
  No periapical pathosis.
  No radicular resorption defects.
  arm group label: Apple vinegar group
  arm group type: Experimental
  description: After hemostasis of the exposed pulp is achieved, Apple vinegar will be used for dentin conditioning for 5 mins then 1-2 mm thickness of MTA placed on the exposed pulp chamber.
  arm group label: EDTA 17% group
  arm group type: Active Comparator
  description: After hemostasis of the exposed pulp is achieved, EDTA 17 % will be used for dentin conditioning then 1-2 mm thickness of MTA placed on the exposed pulp chamber.
  intervention type: Other
  intervention name: Apple vinegar or EDTA 17%
  description: Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.
  arm group label: Apple vinegar group
  arm group label: EDTA 17% group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mona R Abo El Wafa Ahmed, PhD
  role: Principal Investigator
  affiliation: Faculty of Dentistry, Sinai University.
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Sinai University
  investigator full name: Mona Rizk Abo El Wafa Ahmed
  investigator title: principal investigator
  mesh term: Pulpitis
  mesh term: Acetic Acid
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd time frame: 2 years