<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/NCT04454814</url>
  </required_header>
  <id_info>
    <org_study_id>15-6/15</org_study_id>
    <nct_id>NCT04454814</nct_id>
  </id_info>
  <brief_title>Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems</brief_title>
  <official_title>Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege 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>
      A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical&#xD;
      lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper&#xD;
      Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer&#xD;
      using single cone technique for mesial roots and for distal roots single cone and cold&#xD;
      lateral compaction technique. Root canal treatment was performed in a single visit.&#xD;
      Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours&#xD;
      and 7 days after obturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to compare the effect of root canal preparation techniques on the&#xD;
      occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar&#xD;
      teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular&#xD;
      molar teeth with periapical lesion were included. For each patient, teeth were prepared with&#xD;
      Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha&#xD;
      and resin-based sealer using single cone technique for mesial roots and for distal roots&#xD;
      single cone and cold lateral compaction technique. Root canal treatment was performed in a&#xD;
      single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24,&#xD;
      48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested&#xD;
      instrumentation systems, the Mann Whitney test was used. Differences between postoperative&#xD;
      pain intencity for each instrumentation technique, at different time intervals, were assessed&#xD;
      by the Friedman test. For the association of pain and an analgesic intake with gender, the&#xD;
      chi-square test was performed. For the association of pain with age and an analgesic intake&#xD;
      were calculated using Mann Whitney test. A P value &lt; .05 or less was considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of postoperative pain</measure>
    <time_frame>6-hour to 7-day</time_frame>
    <description>Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Asymptomatic Molar Teeth With Periapical Lesions</condition>
  <arm_group>
    <arm_group_label>Rotary Engine-driven Instruments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reciprocal Engine-driven Instruments</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protaper Universal instruments</intervention_name>
    <description>Root canal treatment using Protaper Universal instruments</description>
    <arm_group_label>Rotary Engine-driven Instruments</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reciproc Blue instruments</intervention_name>
    <description>Root canal treatment using Reciproc Blue instruments</description>
    <arm_group_label>Reciprocal Engine-driven Instruments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients without systemic diseases&#xD;
&#xD;
          -  Patients who had a mandibular first molar with asymptomatic periapical lesion without&#xD;
             previous endodontic treatment with no sensitivity to percussion&#xD;
&#xD;
          -  Patients who had no spontaneous pre-treatment pain&#xD;
&#xD;
          -  Patients not having taken any analgesics, antibiotics or corticosteroids before the&#xD;
             treatment visit,&#xD;
&#xD;
          -  Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal&#xD;
             anti-inflammatory drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had severe periodontal disease&#xD;
&#xD;
          -  The teeth with previous endodontic treatment&#xD;
&#xD;
          -  The teeth with root canal calcification, root resorption&#xD;
&#xD;
          -  The teeth that could not be isolated with rubber dam or were not suitable for further&#xD;
             restoration&#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>Gözde Kandemir Demirci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ege University Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seniha Miçooğulları Kurt</last_name>
    <role>Study Chair</role>
    <affiliation>Ege University Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Burcu Serefoglu</last_name>
    <role>Study Chair</role>
    <affiliation>Ege University Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehmet E Kaval</last_name>
    <role>Study Chair</role>
    <affiliation>Ege University Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehmet K Çalışkan</last_name>
    <role>Study Chair</role>
    <affiliation>Ege University Faculty of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gözde Kandemir Demirci</name>
      <address>
        <city>İzmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.</citation>
    <PMID>28179917</PMID>
  </reference>
  <reference>
    <citation>Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.</citation>
    <PMID>27041109</PMID>
  </reference>
  <results_reference>
    <citation>Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.</citation>
    <PMID>26614017</PMID>
  </results_reference>
  <results_reference>
    <citation>Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.</citation>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Gözde Kandemir Demirci</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>one-visit root canal treatment,</keyword>
  <keyword>engine-driven instruments,</keyword>
  <keyword>asymptomatic molar teeth wtih periapical lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <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/NCT04454814
org study id: 15-6/15
nct id: NCT04454814
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical
      lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper
      Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer
      using single cone technique for mesial roots and for distal roots single cone and cold
      lateral compaction technique. Root canal treatment was performed in a single visit.
      Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours
      and 7 days after obturation.
The aim of this study was to compare the effect of root canal preparation techniques on the
      occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar
      teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular
      molar teeth with periapical lesion were included. For each patient, teeth were prepared with
      Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha
      and resin-based sealer using single cone technique for mesial roots and for distal roots
      single cone and cold lateral compaction technique. Root canal treatment was performed in a
      single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24,
      48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested
      instrumentation systems, the Mann Whitney test was used. Differences between postoperative
      pain intencity for each instrumentation technique, at different time intervals, were assessed
      by the Friedman test. For the association of pain and an analgesic intake with gender, the
      chi-square test was performed. For the association of pain with age and an analgesic intake
      were calculated using Mann Whitney test. A P value < .05 or less was considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The incidence of postoperative pain
time frame: 6-hour to 7-day
description: Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.
arm group label: Rotary Engine-driven Instruments
arm group type: Active Comparator
description: The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.
arm group label: Reciprocal Engine-driven Instruments
arm group type: Active Comparator
description: The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.
intervention type: Other
intervention name: Protaper Universal instruments
description: Root canal treatment using Protaper Universal instruments
arm group label: Rotary Engine-driven Instruments
intervention type: Other
intervention name: Reciproc Blue instruments
description: Root canal treatment using Reciproc Blue instruments
arm group label: Reciprocal Engine-driven Instruments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gözde Kandemir Demirci
role: Principal Investigator
affiliation: Ege University Faculty of Dentistry
last name: Seniha Miçooğulları Kurt
role: Study Chair
affiliation: Ege University Faculty of Dentistry
last name: Burcu Serefoglu
role: Study Chair
affiliation: Ege University Faculty of Dentistry
last name: Mehmet E Kaval
role: Study Chair
affiliation: Ege University Faculty of Dentistry
last name: Mehmet K Çalışkan
role: Study Chair
affiliation: Ege University Faculty of Dentistry
facility: 
country: Turkey
citation: Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.
PMID: 28179917
citation: Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
PMID: 27041109
citation: Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
PMID: 26614017
citation: Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Gözde Kandemir Demirci
investigator title: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: No