<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/NCT04462731</url>
  </required_header>
  <id_info>
    <org_study_id>825494</org_study_id>
    <nct_id>NCT04462731</nct_id>
  </id_info>
  <brief_title>Post-endodontic Pain Survey</brief_title>
  <official_title>Postoperative Pain After One-visit Root Canal Treatment on Teeth With Vital Pulps: Comparison of Two Different Root Filling Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ya-Hsin Yu, DDS, MS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      As part of root canal treatment, canals should be sealed to prevent further contaminations.&#xD;
      There are multiple accepted techniques to fill-obturate canals. In the past, different&#xD;
      obturation techniques have been compared. The most current technique used, a single cone with&#xD;
      bioceramic sealer, has not been compared. This clinical investigation will compare the&#xD;
      postoperative pain of this technique to another common technique used in our clinic.&#xD;
      Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: Comparison&#xD;
      of three different obturation techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Non-surgical root canal treatment:&#xD;
All teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% NaOCl was used as the main irrigant. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% NaOCl and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>4-, 24-, and 48-hour after receiving root canal treatment</time_frame>
    <description>Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Endodontic Disease</condition>
  <condition>Obturation</condition>
  <arm_group>
    <arm_group_label>Obturation technique: WVT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obturation technique: SBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical root canal treatment filled with WVT</intervention_name>
    <description>All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.</description>
    <arm_group_label>Obturation technique: WVT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical root canal treatment filled with SBT</intervention_name>
    <description>All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.</description>
    <arm_group_label>Obturation technique: SBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of asymptomatic or symptomatic irreversible pulpitis according to AAE&#xD;
             consensus. The diagnosis was based on clinical examinations and confirmed upon&#xD;
             accessing the teeth.&#xD;
&#xD;
          -  Consenting adults age 18 years and older&#xD;
&#xD;
          -  Non-contributory medical history (ASA Class I &amp; II)&#xD;
&#xD;
          -  Included patients were given oral and written information agreed for participation and&#xD;
             signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-consenting patients and patients below 18 years of age&#xD;
&#xD;
          -  Medical history with ASA Class III &amp; IV&#xD;
&#xD;
          -  Non-restorable teeth&#xD;
&#xD;
          -  Teeth with a non-vital pulp&#xD;
&#xD;
          -  Periodontal probing depths were more than 4mm&#xD;
&#xD;
          -  Pre-medication with antibiotics and/or analgesics 24 hours before the treatment&#xD;
&#xD;
          -  Patients taking analgesics routinely for non-dental reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <results_first_submitted>July 9, 2020</results_first_submitted>
  <results_first_submitted_qc>July 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2020</results_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Ya-Hsin Yu, DDS, MS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Postoperative Pain</keyword>
  <keyword>Bioceramic</keyword>
  <keyword>Root canal filling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT04462731/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT04462731/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Only recruited irreversible pulpitis cases that received single-visit root canal treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Obturation Technique: WVT</title>
          <description>Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.</description>
        </group>
        <group group_id="P2">
          <title>Obturation Technique: SBT</title>
          <description>Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Obturation Technique: WVT</title>
          <description>Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.</description>
        </group>
        <group group_id="B2">
          <title>Obturation Technique: SBT</title>
          <description>Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.2" spread="14.4"/>
                    <measurement group_id="B2" value="46.7" spread="16.6"/>
                    <measurement group_id="B3" value="46.5" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Scale (VAS)</title>
        <description>Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.</description>
        <time_frame>4-, 24-, and 48-hour after receiving root canal treatment</time_frame>
        <population>The data from all 92 survey was included for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Obturation Technique: WVT</title>
            <description>Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.</description>
          </group>
          <group group_id="O2">
            <title>Obturation Technique: SBT</title>
            <description>Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale (VAS)</title>
          <description>Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.</description>
          <population>The data from all 92 survey was included for analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Preoperative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.06" lower_limit="2.95" upper_limit="5.17"/>
                    <measurement group_id="O2" value="2.68" lower_limit="1.90" upper_limit="3.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative 4-hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.41" lower_limit="1.74" upper_limit="3.09"/>
                    <measurement group_id="O2" value="2.27" lower_limit="1.65" upper_limit="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative 24-hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" lower_limit="1.27" upper_limit="2.63"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.14" upper_limit="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative 48-hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" lower_limit="0.60" upper_limit="1.70"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.54" upper_limit="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1.Preoperative 2. 4-, 24-, and 48-hour postoperatively</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Obturation Technique: WVT</title>
          <description>Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.</description>
        </group>
        <group group_id="E2">
          <title>Obturation Technique: SBT</title>
          <description>Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ya-Hsin Yu</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-898-4927</phone>
      <email>yayu@upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04462731
org study id: 825494
nct id: NCT04462731
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of root canal treatment, canals should be sealed to prevent further contaminations.
      There are multiple accepted techniques to fill-obturate canals. In the past, different
      obturation techniques have been compared. The most current technique used, a single cone with
      bioceramic sealer, has not been compared. This clinical investigation will compare the
      postoperative pain of this technique to another common technique used in our clinic.
      Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: Comparison
      of three different obturation techniques.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Non-surgical root canal treatment:
All teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% NaOCl was used as the main irrigant. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% NaOCl and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Visual Analogue Scale (VAS)
time frame: 4-, 24-, and 48-hour after receiving root canal treatment
description: Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.
arm group label: Obturation technique: WVT
arm group type: Experimental
description: Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
arm group label: Obturation technique: SBT
arm group type: Active Comparator
description: Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
intervention type: Procedure
intervention name: Non-surgical root canal treatment filled with WVT
description: All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.
arm group label: Obturation technique: WVT
intervention type: Procedure
intervention name: Non-surgical root canal treatment filled with SBT
description: All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.
arm group label: Obturation technique: SBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Ya-Hsin Yu, DDS, MS
investigator title: Principal Investigator
mesh term: Dental Pulp Diseases
mesh term: Pain, Postoperative
sharing ipd: Undecided
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