<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/NCT03756363</url>
  </required_header>
  <id_info>
    <org_study_id>B.30.2.YYU.0.01.00.00/125</org_study_id>
    <nct_id>NCT03756363</nct_id>
  </id_info>
  <brief_title>The Effect of Solvent Usage on Post-treatment Pain</brief_title>
  <official_title>Postoperative Pain After Removal of Gutta-percha From Root Canals in Endodontic Retreatment Using a Solvent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl 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>
      No clinical evidence has been yet published regarding the comparison of postoperative pain&#xD;
      after removal of the root canal fillings with or without solvent. The aim of this study was&#xD;
      to evaluate the effect of combined usage of ProTaper retreatment instruments and a&#xD;
      gutta-percha solvent, on the postoperative pain intensity after retreatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific literature contains a few studies regarding the amount of apically extruded debris&#xD;
      caused by solvent or solvent free use of rotary instruments. It was reported that the use of&#xD;
      ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount&#xD;
      of apically extruded debris compared to their solvent free use. Nevertheless,no clinical&#xD;
      evidence has been yet published regarding the comparison of postoperative pain after removal&#xD;
      of the root canal fillings with or without solvent. The aim of this study was to evaluate the&#xD;
      effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the&#xD;
      postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred&#xD;
      to Department of Endodontics with a diagnose of failed root canal treatment were examined&#xD;
      radiographically and clinically. Endodontically treated, clinically asymptomatic,&#xD;
      single-rooted teeth with one canal exhibiting chronic periapical infection were included. A&#xD;
      hundred cases who matched the determined criteria were selected and randomly allocated to two&#xD;
      groups:&#xD;
&#xD;
      Non-solvent Group (n=50):&#xD;
&#xD;
      ProTaper retreatment instruments were used in combination with with X-Smart electric motor&#xD;
      for the removal of root canal fillings.&#xD;
&#xD;
      Solvent Group (n=50):&#xD;
&#xD;
      ProTaper retreatment instruments were used with the abovementioned technique but in&#xD;
      combination with a gutta-percha solvent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 5, 2019</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>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain after removal of gutta-percha with or without solvent</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain after removal of gutta-percha with or without solvent</measure>
    <time_frame>24 to 48 hours postoperatively</time_frame>
    <description>Pain intensity was evaluated at 48 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine' . All patients were requested to mark a number corresponding to their average pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain after removal of gutta-percha with or without solvent</measure>
    <time_frame>48 to 72 hours postoperatively</time_frame>
    <description>Pain intensity was evaluated at 72 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'. All patients were requested to mark a number corresponding to their average pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Root Canal Infection</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Non-solvent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-solvent use of a rotary retreatment system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solvent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solvent use in combination with a rotary retreatment system</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-solvent</intervention_name>
    <description>Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.</description>
    <arm_group_label>Non-solvent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Solvent</intervention_name>
    <description>Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.</description>
    <arm_group_label>Solvent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy patient who has a failed root canal treatment.&#xD;
&#xD;
          -  Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with&#xD;
             chronic apical periodontitis.&#xD;
&#xD;
          -  Patients agreed to parcitipate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overfilled teeth,&#xD;
&#xD;
          -  teeth with intraradicular posts,&#xD;
&#xD;
          -  existence of a sinus tract,&#xD;
&#xD;
          -  consumption of antibiotics or analgesics within one month,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  history of trauma,&#xD;
&#xD;
          -  traumatic occlusion&#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>Ozgur G Genc Sen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yuzuncu Yil University, Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali G Erdemir</last_name>
    <role>Study Director</role>
    <affiliation>Yuzuncu Yil University, Faculty of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ozgur Genc Sen</name>
      <address>
        <city>Van</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Ozgur Genc Sen</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Debris extrusion</keyword>
  <keyword>Filling removal</keyword>
  <keyword>solvent</keyword>
  <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/NCT03756363
org study id: B.30.2.YYU.0.01.00.00/125
nct id: NCT03756363
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
No clinical evidence has been yet published regarding the comparison of postoperative pain
      after removal of the root canal fillings with or without solvent. The aim of this study was
      to evaluate the effect of combined usage of ProTaper retreatment instruments and a
      gutta-percha solvent, on the postoperative pain intensity after retreatment.
Scientific literature contains a few studies regarding the amount of apically extruded debris
      caused by solvent or solvent free use of rotary instruments. It was reported that the use of
      ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount
      of apically extruded debris compared to their solvent free use. Nevertheless,no clinical
      evidence has been yet published regarding the comparison of postoperative pain after removal
      of the root canal fillings with or without solvent. The aim of this study was to evaluate the
      effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the
      postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred
      to Department of Endodontics with a diagnose of failed root canal treatment were examined
      radiographically and clinically. Endodontically treated, clinically asymptomatic,
      single-rooted teeth with one canal exhibiting chronic periapical infection were included. A
      hundred cases who matched the determined criteria were selected and randomly allocated to two
      groups:

      Non-solvent Group (n=50):

      ProTaper retreatment instruments were used in combination with with X-Smart electric motor
      for the removal of root canal fillings.

      Solvent Group (n=50):

      ProTaper retreatment instruments were used with the abovementioned technique but in
      combination with a gutta-percha solvent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double-blind
measure: Postoperative pain after removal of gutta-percha with or without solvent
time frame: 24 hours postoperatively
description: Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.
measure: Postoperative pain after removal of gutta-percha with or without solvent
time frame: 24 to 48 hours postoperatively
description: Pain intensity was evaluated at 48 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine' . All patients were requested to mark a number corresponding to their average pain.
measure: Postoperative pain after removal of gutta-percha with or without solvent
time frame: 48 to 72 hours postoperatively
description: Pain intensity was evaluated at 72 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'. All patients were requested to mark a number corresponding to their average pain.
arm group label: Non-solvent
arm group type: Experimental
description: Non-solvent use of a rotary retreatment system
arm group label: Solvent
arm group type: Experimental
description: Solvent use in combination with a rotary retreatment system
intervention type: Procedure
intervention name: Non-solvent
description: Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.
arm group label: Non-solvent
intervention type: Procedure
intervention name: Solvent
description: Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.
arm group label: Solvent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ozgur G Genc Sen
role: Principal Investigator
affiliation: Yuzuncu Yil University, Faculty of Dentistry
last name: Ali G Erdemir
role: Study Director
affiliation: Yuzuncu Yil University, Faculty of Dentistry
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Ozgur Genc Sen
investigator title: Assistant professor
sharing ipd: No