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/NCT05974748</url>
    </required_header>
    <id_info>
      <org_study_id>2908</org_study_id>
      <nct_id>NCT05974748</nct_id>
    </id_info>
    <brief_title>Role of Propolis Endodontic Irrigant on Post-Operative Pain</brief_title>
    <official_title>Comparative Evaluation of Propolis and Sodium Hypochlorite as Endodontic Irrigants on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dow University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dow University of Health Sciences</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 goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic&#xD;
        irrigants in patients presenting with symptomatic irreversible pulpitis.&#xD;
  &#xD;
        . The main question it aims to answer is:&#xD;
  &#xD;
        • if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the&#xD;
        intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS&#xD;
        pain score. Participants will undergo root canal treatment of their teeth using either 20%&#xD;
        propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.&#xD;
  &#xD;
        Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of&#xD;
        Post-Operative Pain using visual analogue scale over 72 hour duration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its&#xD;
        unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have&#xD;
        deleterious effects on the dentine, creating unfavorable structural and mechanical&#xD;
        alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a&#xD;
        biocompatible, equally effective, and dentine friendly irrigant with greater patient&#xD;
        acceptance in taste and odor.&#xD;
  &#xD;
        The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic&#xD;
        characteristics of Propolis on post-endodontic pain as an irrigant, in patients with&#xD;
        symptomatic irreversible pulpitis. This research will endeavor to fill this gap in&#xD;
        literature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 15, 2023</primary_completion_date>
    <phase>Phase 3</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>2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants will not be aware of their interventional group. A proforma and pain intensity scale will be provided to the patient by an intern not involved in the study, to be completed at 24, 48, and 72 hours following the procedure to assess post-operative pain. this proforma will be collected and assessed by the intern.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in post-operative pain intensity on visual analogue scale(0-10)</measure>
      <time_frame>24 hours, 48 hours and 72 hours</time_frame>
      <description>Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Need of rescue medicine in both groups</measure>
      <time_frame>within first 24 hours</time_frame>
      <description>Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">44</enrollment>
    <condition>Post-operative Pain</condition>
    <condition>Symptomatic Irreversible Pulpitis</condition>
    <arm_group>
      <arm_group_label>Sodium Hypochlorite</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Propolis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sodium hypochlorite 5.25%</intervention_name>
      <description>The participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal.</description>
      <arm_group_label>Sodium Hypochlorite</arm_group_label>
      <other_name>NaOCl</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propolis 20%</intervention_name>
      <description>In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.</description>
      <arm_group_label>Propolis</arm_group_label>
      <other_name>Bee glue</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ASA-I and II individuals who are between the ages of 18 and 60 years.&#xD;
  &#xD;
            2. Patients with mandibular and maxillary premolars who have been diagnosed with&#xD;
               symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical&#xD;
               periodontitis).&#xD;
  &#xD;
            3. Patients who score moderate to severe (4-10) on a preoperative visual analogue scale&#xD;
               (VAS=1-10)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients suffering from severe pain because of traumatic occlusion.&#xD;
  &#xD;
            2. Teeth with extensive damage, calcified canals, periapical radiolucency, root&#xD;
               resorption, and an open apex.&#xD;
  &#xD;
            3. Patients with compromised medical condition (ASA-III and above)&#xD;
  &#xD;
            4. Patients who are unable to communicate effectively in either Urdu or English.&#xD;
  &#xD;
            5. Pregnant and lactating ladies&#xD;
  &#xD;
            6. Patients who are allergic to honey or bee pollen.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tayyaba Tahira, BDS FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dow International Dental College, Dow University of Health Sciences</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Farah Naz, BDS FCPS</last_name>
      <role>Study Director</role>
      <affiliation>Dow International Dental College, Dow University of Health Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dow International Dental College</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>75500</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Tayyaba Tahira</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Propolis</keyword>
    <keyword>Endodontic Irrigant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulpitis</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propolis</mesh_term>
      <mesh_term>Sodium Hypochlorite</mesh_term>
      <mesh_term>Eusol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only investigators and co-investigators of this study will be able to access to participants' personal data.&#xD;
  Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences</ipd_description>
    </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/NCT05974748
  org study id: 2908
  nct id: NCT05974748
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic
        irrigants in patients presenting with symptomatic irreversible pulpitis.
  
        . The main question it aims to answer is:
  
        • if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the
        intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS
        pain score. Participants will undergo root canal treatment of their teeth using either 20%
        propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.
  
        Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of
        Post-Operative Pain using visual analogue scale over 72 hour duration.
  Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its
        unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have
        deleterious effects on the dentine, creating unfavorable structural and mechanical
        alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a
        biocompatible, equally effective, and dentine friendly irrigant with greater patient
        acceptance in taste and odor.
  
        The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic
        characteristics of Propolis on post-endodontic pain as an irrigant, in patients with
        symptomatic irreversible pulpitis. This research will endeavor to fill this gap in
        literature.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants will not be aware of their interventional group. A proforma and pain intensity scale will be provided to the patient by an intern not involved in the study, to be completed at 24, 48, and 72 hours following the procedure to assess post-operative pain. this proforma will be collected and assessed by the intern.
  measure: Change in post-operative pain intensity on visual analogue scale(0-10)
  time frame: 24 hours, 48 hours and 72 hours
  description: Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
  measure: Need of rescue medicine in both groups
  time frame: within first 24 hours
  description: Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
  arm group label: Sodium Hypochlorite
  arm group type: Active Comparator
  description: 5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl
  arm group label: Propolis
  arm group type: Experimental
  description: Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue
  intervention type: Drug
  intervention name: Sodium hypochlorite 5.25%
  description: The participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal.
  arm group label: Sodium Hypochlorite
  other name: NaOCl
  intervention type: Drug
  intervention name: Propolis 20%
  description: In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.
  arm group label: Propolis
  other name: Bee glue
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tayyaba Tahira, BDS FCPS
  role: Principal Investigator
  affiliation: Dow International Dental College, Dow University of Health Sciences
  last name: Farah Naz, BDS FCPS
  role: Study Director
  affiliation: Dow International Dental College, Dow University of Health Sciences
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Dow University of Health Sciences
  investigator full name: Tayyaba Tahira
  investigator title: Lecturer
  mesh term: Pulpitis
  mesh term: Pain, Postoperative
  mesh term: Propolis
  mesh term: Sodium Hypochlorite
  mesh term: Eusol
  sharing ipd: No
  ipd description: Only investigators and co-investigators of this study will be able to access to participants' personal data.
  Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences