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/NCT06013293</url>
    </required_header>
    <id_info>
      <org_study_id>SOD/ERB/2023/19</org_study_id>
      <nct_id>NCT06013293</nct_id>
    </id_info>
    <brief_title>Evaluation of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Based Sealer After Single Visit Endodontic</brief_title>
    <official_title>Evalution of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Sealer After Single Visit Endodontic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pakistan Institute of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pakistan Institute of Medical 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 root canal therapy is thorough disinfection and obturation of the root canal&#xD;
        system in all its dimensions and promote periradicular tissue repair.This study was done to&#xD;
        compare the postopertaive pain after single visit endodontics using resin based sealer and&#xD;
        zinc oxide eugeonal sealer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 100 patients requiring endodontic treatment for permanent molar in accordance with&#xD;
        the inclusion and exclusion criteria will be selected for the study. The treatment and study&#xD;
        design will be explained to the patients in their own comprehendible language and a written&#xD;
        informed consent will be obtained from the voluntary patients who participated in the study.&#xD;
        A cold test and electric pulp-test was used to assess pulp vitality. Based on clinical and&#xD;
        radiographic findings, the patients diagnosis of irreversible pulpitis. Patients will be&#xD;
        randomly divided into two groups Group A = resin based sealer and Group B = Zinc oxide&#xD;
        eugenol sealer. Prior to treatment the patients will be instructed how to complete a visual&#xD;
        analog scale (VAS) to determine their pain score. The VAS included a 10 cm straight&#xD;
        horizontal line numbered at each centimeter with the following criteria.Local anesthetic with&#xD;
        2% lignocaine containi Local anesthetic with 2% lignocaine containing 1:80000 epinephrine&#xD;
        will be administered to each patient after recording preoperative pain levels . A rubber dam&#xD;
        will be applied. The endodontic access cavities will be prepared with endo access burs&#xD;
        .Working length will be established with #10 K file and the root canal will be instrumented&#xD;
        with one shape rotary system up to #25.6% under copious irrigation with 3% sodium&#xD;
        hypochlorite and normal saline. Before obturation root canals will be final rinse with 5 ml&#xD;
        of 17% EDTA solution. In both groups, the root canal will be dried with paper points and&#xD;
        obturated using gutta-percha cones and Resin based sealer/zinc oxide eugenol sealer. Coronal&#xD;
        access cavities will be restored with direct composite restorations using dentinal adhesives&#xD;
        and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h&#xD;
        to determine their post-operative pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Post operative pain</measure>
      <time_frame>immediately after the procedure</time_frame>
      <description>. Postoperative Visual analogue pain scores will be recorded</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Zinc oxide eugenol based sealer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Resin based sealer</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and resin based sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Zinc oxide eugeonal based sealer</intervention_name>
      <description>Zinc oxide-eugenol (ZOE)- based preparations, which have been used in root canal obturation (RCO) for over a hundered years and are known for their antimicrobial activities.slight microleakage and zinc oxide-eugenol's superior antibacterial property,slight microleakage and concerning the lower cytotoxicity, the zinc oxide-eugenol (ZOE) sealer can be used for root canal obturation as an endodontic sealer.After root canal prepartion , the root canal will be dried with paper points and obturated using gutta-percha cones and zinc oxide eugenol sealer.</description>
      <arm_group_label>Zinc oxide eugenol based sealer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Resin Based Sealer</intervention_name>
      <description>resin-based sealer used frequently as a gold standard for endodontic sealers, due to its good physicochemical properties and provide satisfactory adhesion interface with dentin radicular surface.After root canal preparation, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer</description>
      <arm_group_label>Resin based sealer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient who agree to participate in study&#xD;
  &#xD;
            2. ASA CLASSIFICATION 1or 2&#xD;
  &#xD;
            3. Minimum age of 18years old and maximum age of 65 years old&#xD;
  &#xD;
            4. Maxillary and Mandibular single rooted teeth included in the study&#xD;
  &#xD;
            5. Patient with symptomatic irreversible pulpitis with either normal apical tissue or&#xD;
               symptomatic apical periodontitis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1. ASA Classification 3 to 5 2. Patient with immature apices and root resorption will be&#xD;
          excluded from the study.&#xD;
  &#xD;
          3. Severe periodontal problem. 4. Vertical or horizontal root fractures will be excluded&#xD;
          from the study 5. Patients who will be already on analgesia within 24 hours excluded from&#xD;
          study 6. Those requiring root canal treatment of two or more teeth ipsilaterally (since the&#xD;
          pain caused by any of these teeth can result in false positive reading) will be excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahsen Amin, BDS</last_name>
      <phone>03315161642</phone>
      <email>ahsen_amin@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Aqsa Waheed, BDs</last_name>
      <phone>03063422518</phone>
      <email>q.aqsa@rocketmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>School of Dentistry</name>
        <address>
          <city>Islamabad</city>
          <zip>0920</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahsen Amin, BDS</last_name>
        <phone>03315161642</phone>
        <email>ahsen_amin@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Aqsa Waheed, BDS</last_name>
        <phone>03063422518</phone>
        <email>q.aqsa@rocketmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pakistan Institute of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Ahsen amin</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>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Zinc Oxide</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06013293
  org study id: SOD/ERB/2023/19
  nct id: NCT06013293
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of root canal therapy is thorough disinfection and obturation of the root canal
        system in all its dimensions and promote periradicular tissue repair.This study was done to
        compare the postopertaive pain after single visit endodontics using resin based sealer and
        zinc oxide eugeonal sealer
  A total of 100 patients requiring endodontic treatment for permanent molar in accordance with
        the inclusion and exclusion criteria will be selected for the study. The treatment and study
        design will be explained to the patients in their own comprehendible language and a written
        informed consent will be obtained from the voluntary patients who participated in the study.
        A cold test and electric pulp-test was used to assess pulp vitality. Based on clinical and
        radiographic findings, the patients diagnosis of irreversible pulpitis. Patients will be
        randomly divided into two groups Group A = resin based sealer and Group B = Zinc oxide
        eugenol sealer. Prior to treatment the patients will be instructed how to complete a visual
        analog scale (VAS) to determine their pain score. The VAS included a 10 cm straight
        horizontal line numbered at each centimeter with the following criteria.Local anesthetic with
        2% lignocaine containi Local anesthetic with 2% lignocaine containing 1:80000 epinephrine
        will be administered to each patient after recording preoperative pain levels . A rubber dam
        will be applied. The endodontic access cavities will be prepared with endo access burs
        .Working length will be established with #10 K file and the root canal will be instrumented
        with one shape rotary system up to #25.6% under copious irrigation with 3% sodium
        hypochlorite and normal saline. Before obturation root canals will be final rinse with 5 ml
        of 17% EDTA solution. In both groups, the root canal will be dried with paper points and
        obturated using gutta-percha cones and Resin based sealer/zinc oxide eugenol sealer. Coronal
        access cavities will be restored with direct composite restorations using dentinal adhesives
        and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h
        to determine their post-operative pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Post operative pain
  time frame: immediately after the procedure
  description: . Postoperative Visual analogue pain scores will be recorded
  arm group label: Zinc oxide eugenol based sealer
  arm group type: Experimental
  description: Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.
  arm group label: Resin based sealer
  arm group type: Active Comparator
  description: Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and resin based sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.
  intervention type: Procedure
  intervention name: Zinc oxide eugeonal based sealer
  description: Zinc oxide-eugenol (ZOE)- based preparations, which have been used in root canal obturation (RCO) for over a hundered years and are known for their antimicrobial activities.slight microleakage and zinc oxide-eugenol's superior antibacterial property,slight microleakage and concerning the lower cytotoxicity, the zinc oxide-eugenol (ZOE) sealer can be used for root canal obturation as an endodontic sealer.After root canal prepartion , the root canal will be dried with paper points and obturated using gutta-percha cones and zinc oxide eugenol sealer.
  arm group label: Zinc oxide eugenol based sealer
  intervention type: Procedure
  intervention name: Resin Based Sealer
  description: resin-based sealer used frequently as a gold standard for endodontic sealers, due to its good physicochemical properties and provide satisfactory adhesion interface with dentin radicular surface.After root canal preparation, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer
  arm group label: Resin based sealer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahsen Amin, BDS
  phone: 03315161642
  email: ahsen_amin@hotmail.com
  last name: Aqsa Waheed, BDs
  phone: 03063422518
  email: q.aqsa@rocketmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Pakistan Institute of Medical Sciences
  investigator full name: Ahsen amin
  investigator title: Principal investigator
  mesh term: Pain, Postoperative
  mesh term: Zinc Oxide