<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/NCT03029520</url>
  </required_header>
  <id_info>
    <org_study_id>BAPKOM 4949</org_study_id>
    <nct_id>NCT03029520</nct_id>
  </id_info>
  <brief_title>Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers</brief_title>
  <official_title>Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate and compare postoperative pain and overextension of&#xD;
      root canal filling after root canal treatment using a carrier-based obturation system and two&#xD;
      different sealers.&#xD;
&#xD;
      In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160&#xD;
      patients were treated. Patients with vital and devital teeth were assigned to four groups&#xD;
      using a randomized block design with block sizes of 10 patients each. The groups were&#xD;
      composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth&#xD;
      treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus&#xD;
      sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator&#xD;
      prepared root canals and filled them with sealer using the carrier-based obturation&#xD;
      technique. Radiographs were taken and obturation length was recorded. Patients recorded pain&#xD;
      scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6,&#xD;
      6-12, 12-24, and 24-72 h..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled clinical study was conducted to compare the incidence and&#xD;
      intensity of post-obturation pain, evaluate the overextension of filling material&#xD;
      radiographically, and assess the relationship between pain and analgesic intake in patients&#xD;
      with vital and devital teeth undergoing carrier-based obturation with two different sealers&#xD;
      (iRoot SP, AH Plus)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of postoperative pain by using VAS scale after obturation with different sealers.</measure>
    <time_frame>72 hour</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Endodontically-Treated Teeth</condition>
  <arm_group>
    <arm_group_label>pain iRoot SP sealer Vital Pulp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pain iRoot SP sealer Devital pulp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pain AHPlus Vital pulp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pain AHPlus Devital Pulp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root canal obturation with iRoot SP sealer</intervention_name>
    <description>Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.</description>
    <arm_group_label>pain iRoot SP sealer Devital pulp</arm_group_label>
    <arm_group_label>pain iRoot SP sealer Vital Pulp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root canal obturation with AH Plus Sealer</intervention_name>
    <description>Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.</description>
    <arm_group_label>pain AHPlus Devital Pulp</arm_group_label>
    <arm_group_label>pain AHPlus Vital pulp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no systemic diseases&#xD;
&#xD;
          -  women were not pregnant or breastfeeding status&#xD;
&#xD;
          -  no history of taking analgesics in the previous seven days or other drugs prior to&#xD;
             presenting for treatment.&#xD;
&#xD;
          -  all selected teeth were mandibular molar or mandibular premolar.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic and/or periodontal disease;&#xD;
&#xD;
          -  allergy to local anesthetic agents and/or history of intolerance to nonsteroidal&#xD;
             anti-inflammatory drugs;&#xD;
&#xD;
          -  requirement for antibiotic prophylaxis&#xD;
&#xD;
          -  open tooth apex&#xD;
&#xD;
          -  pacemaker use&#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_official>
    <last_name>oguz yoldas, professor</last_name>
    <role>Study Chair</role>
    <affiliation>vice dean</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Ayfer Atav Ateş</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>Endodontic Postoperative Pain</keyword>
  <keyword>iRoot SP Sealer</keyword>
  <keyword>Randomized Clinical Trial</keyword>
  <keyword>Herofill carrier-based obturation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Nonvital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The study will be shared at Turkish Council of Higher education thesis center</ipd_description>
  </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/NCT03029520
org study id: BAPKOM 4949
nct id: NCT03029520
lead sponsor: 
has dmc: Yes
The aim of this study was to evaluate and compare postoperative pain and overextension of
      root canal filling after root canal treatment using a carrier-based obturation system and two
      different sealers.

      In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160
      patients were treated. Patients with vital and devital teeth were assigned to four groups
      using a randomized block design with block sizes of 10 patients each. The groups were
      composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth
      treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus
      sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator
      prepared root canals and filled them with sealer using the carrier-based obturation
      technique. Radiographs were taken and obturation length was recorded. Patients recorded pain
      scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6,
      6-12, 12-24, and 24-72 h..
This randomized controlled clinical study was conducted to compare the incidence and
      intensity of post-obturation pain, evaluate the overextension of filling material
      radiographically, and assess the relationship between pain and analgesic intake in patients
      with vital and devital teeth undergoing carrier-based obturation with two different sealers
      (iRoot SP, AH Plus)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The incidence of postoperative pain by using VAS scale after obturation with different sealers.
time frame: 72 hour
arm group label: pain iRoot SP sealer Vital Pulp
arm group type: Active Comparator
description: Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp.
arm group label: pain iRoot SP sealer Devital pulp
arm group type: Active Comparator
description: Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp.
arm group label: pain AHPlus Vital pulp
arm group type: Active Comparator
description: Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp.
arm group label: pain AHPlus Devital Pulp
arm group type: Active Comparator
description: Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp.
intervention type: Other
intervention name: Root canal obturation with iRoot SP sealer
description: Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
arm group label: pain iRoot SP sealer Devital pulp
arm group label: pain iRoot SP sealer Vital Pulp
intervention type: Other
intervention name: Root canal obturation with AH Plus Sealer
description: Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
arm group label: pain AHPlus Devital Pulp
arm group label: pain AHPlus Vital pulp
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: oguz yoldas, professor
role: Study Chair
affiliation: vice dean
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Ayfer Atav Ateş
investigator title: Research assistant
mesh term: Tooth, Nonvital
sharing ipd: Yes
ipd description: The study will be shared at Turkish Council of Higher education thesis center