<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/NCT03791762</url>
  </required_header>
  <id_info>
    <org_study_id>KAEK/389</org_study_id>
    <nct_id>NCT03791762</nct_id>
  </id_info>
  <brief_title>Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instruments</brief_title>
  <official_title>Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instrumentation System Manufactured From Different Ni-Ti Alloys</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ondokuz Mayıs University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ondokuz Mayıs University</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>
      In an ideal endodontic treatment, maintenance of the original root canal morphology of the&#xD;
      canal during root canal preparation, an ideal preparation and obturation is essential. Even&#xD;
      if all stages are ideal, pain after endodontic treatment is a clinical condition that may&#xD;
      occur after a few hours or several days. Post-operative pain after endodontic treatment is an&#xD;
      undesirable condition which makes the clinician and the patient a distressing condition. Many&#xD;
      clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which&#xD;
      means that postoperative pain is a clinical symptom that should be considered for&#xD;
      endodontist.&#xD;
&#xD;
      The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary&#xD;
      motion, and their center of mass or center of rotation is positioned off-center relative to&#xD;
      the instrument's central axis of rotation. During rotation, the files of this design produce&#xD;
      a mechanical wave of motion, which travels along the length of the working part of the&#xD;
      instrument, minimizing the contact between the file and dentin. According to the&#xD;
      manufacturer, the offset design of this instrument also improves debris removal and&#xD;
      flexibility in the working part of the file.&#xD;
&#xD;
      New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility&#xD;
      and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a&#xD;
      new thermal treatment called Gold treatment, was introduced on the market presenting some&#xD;
      differences in design, size and taper compared to Wave One. Wave One Gold instrument has a&#xD;
      parallelogram cross-sectional design, having two cutting edges, and consists of four&#xD;
      instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One&#xD;
      presents convex triangular cross-sectional design, besides larger size and taper.&#xD;
&#xD;
      Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest&#xD;
      version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges,&#xD;
      and a noncutting tip. However, REB files are manufactured by altering the molecular structure&#xD;
      through a new heat treatment in order to increase the cyclic fatigue resistance. This new&#xD;
      heat treatment gives the file its blue color. It was reported that REB files have&#xD;
      approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files&#xD;
      can also be relatively prebent to better access curved canals.&#xD;
&#xD;
      However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the&#xD;
      postoperative endodontic pain has not been investigated, yet. The aim of this prospective&#xD;
      clinical trial was to clinically compare the incidence of postoperative pain after use of&#xD;
      different nickel titanium file systems. The purpose of the present study was to evaluate the&#xD;
      incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper&#xD;
      Next, Waveone Gold. The null hypothesis tested was that there is no difference in the&#xD;
      incidence and severity of postoperative pain following with any of the 3 instruments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study, 180 patients who were diagnosed with asymptomatic irreversible pulpitis,&#xD;
      symptomatic irreversible pulpitis, acute apical periodontitis and chronic apical&#xD;
      periodontitis, and who applied to the Endodontics clinic for inclusion in the endodontics&#xD;
      clinic will be included. A female with systemic healthy patients who meet the inclusion&#xD;
      criteria will be treated clinically and radiologically. The age and gender of the patient&#xD;
      will be recorded as patient-dependent variables, and location and type of the tooth to be&#xD;
      treated will be recorded as tooth-dependent variables. Before the root canal treatment, the&#xD;
      responsible researcher will provide training on patients with the Vizual Analog Scale (VAS)&#xD;
      and its use. Root canal treatments will be completed by this responsible investigator. Before&#xD;
      starting root canal treatment, local anesthesia will be applied using 2: Lidocaine anesthetic&#xD;
      solution containing 2: 80,000 epinephrine using the appropriate technique to the tooth. After&#xD;
      anesthesia is provided, endodontic access cavities suitable for the teeth will be opened. The&#xD;
      pulp tissue will be extruded using a turner. Subsequently, according to the entry path file&#xD;
      to be used, the subjects will be assigned to the group that is selected from the closed&#xD;
      envelopes that write the names of the groups, and random manual preparation will be divided&#xD;
      into 3 groups: the R-Pilot file will be used, the rotation preparation will be used, and the&#xD;
      ProGlider file will be used (n = 60). Working lengths will be determined by using K type file&#xD;
      10 and electronic apex finders. The manual preparation group will serve as the control group.&#xD;
      In this group, K type hand files (Dentsply Sirona) # 08, 10, 15, respectively, will be used&#xD;
      with the &quot;forward and retract&quot; technique proposed by Ruddle at the working length. The file&#xD;
      will be moved clockwise and then counterclockwise, by rotating quarterly, the resistance will&#xD;
      be advanced and retracted to the point where resistance is felt in the canal. This&#xD;
      preparation will be made with each file until the working length is reached. In the rotation&#xD;
      group where ProGlider file will be used, the entry way will be prepared at 300 rpm and 5 Ncm&#xD;
      torque values using the torque-controlled endodontic motor (X-Smart) until the working length&#xD;
      is reached with the crown-down technique. In the reciprocating movement group where the&#xD;
      R-Pilot file will be used, the entry path will be prepared using the &quot;Reciproc All&quot; mode in&#xD;
      the VDW-Silver endodontic engine. After the entryway preparation, standard procedures will be&#xD;
      performed for all three groups. The channels will be prepared with ProTaper Next file system.&#xD;
      During treatment, 10 mL of 5% NaOCl irrigation for each channel will be done using a 30-G&#xD;
      irrigation needle. After the preparation, final irrigation will be done with 17% EDTA,&#xD;
      distilled water and 5% NaOCl, respectively. In the samples in all three groups, after the&#xD;
      root canals are dried with sterile paper cone, they will be filled with cold Plus lateral&#xD;
      compaction technique with AH Plus canal paste and gutta percha cone. Patients' phone numbers&#xD;
      will be taken, a copy of the VAS form will be delivered to the patients to be filled in, and&#xD;
      it will be explained that postoperative pain measurements will be made with 6, 12, 18, 24, 36&#xD;
      and 48 hours of VAS. Patients will be reached by phone 48 hours after the completion of root&#xD;
      canal treatments and information about their pain levels will be received. VAS values will be&#xD;
      classified as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-10, severe pain. The&#xD;
      use of analgesics will also be evaluated and recorded within the first 48 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">December 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 25, 2018</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>
    <intervention_model_description>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain Scores using Visual Analogue Scale</measure>
    <time_frame>72 hours</time_frame>
    <description>Visual analogue scale is a measure of pain intensity. In the present study, the visual analogue scale included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. &quot;0&quot; means no pain and &quot;10&quot; means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity and a worse outcome. 1-3 means &quot;mild pain&quot;, 4-6 means &quot;moderate pain&quot; and 7-9 means &quot;severe pain&quot;. There are no subscales.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>WaveOne Gold</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal preparation with WaveOne Gold instrumentation system in a reciprocating manner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reciproc Blue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal preparation with Reciproc Blue instrumentation system in a reciprocating manner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ProTaper Next</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal preparation with ProTaper Next instrumentation system in a rotating manner</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>WaveOne Gold</intervention_name>
    <description>WaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at &quot;WaveOne ALL&quot; setting.</description>
    <arm_group_label>WaveOne Gold</arm_group_label>
    <other_name>Reciprocating root canal preparation instruments</other_name>
    <other_name>Dentsply Sirona, Ballaigues, Switzerland</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Reciproc Blue</intervention_name>
    <description>Reciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at &quot;Reciproc ALL&quot; setting.</description>
    <arm_group_label>Reciproc Blue</arm_group_label>
    <other_name>Reciprocating root canal preparation instruments</other_name>
    <other_name>VDW, Munich, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ProTaper Next</intervention_name>
    <description>ProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm).</description>
    <arm_group_label>ProTaper Next</arm_group_label>
    <other_name>Rotating root canal preparation instrument</other_name>
    <other_name>Dentsply Sirona, Ballaigues, Switzerland</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with no systemic disease or condition&#xD;
&#xD;
          -  Patients having a maxillary or mandibular teeth diagnosed with one of the plural and&#xD;
             periodontal diseases (asymptomatic irreversible pulpitis, symptomatic irreversible&#xD;
             pulpitis, symptomatic apical periodontitis or asymptomatic apical periodontitis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients, who were diagnosed with acute or chronic apical abscesses&#xD;
&#xD;
          -  Patients showing signs of systemic infection&#xD;
&#xD;
          -  Patients with allergies to local anesthetic agents,&#xD;
&#xD;
          -  Patients who are taking medication (analgesic, antibiotic or anti-inflammatory drugs)&#xD;
             during the 7 days before the procedure&#xD;
&#xD;
          -  Patients presenting with multiple teeth requiring treatment or having a progressive&#xD;
             periodontal disease&#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>
  <location>
    <facility>
      <name>Özlem Yilmaz</name>
      <address>
        <city>Samsun</city>
        <zip>55400</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
    <investigator_full_name>Cangül Keskin</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>postoperative pain</keyword>
  <keyword>WaveOne Gold</keyword>
  <keyword>Reciproc Blue</keyword>
  <keyword>ProTaper Next</keyword>
  <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>Polymethyl Methacrylate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03791762
org study id: KAEK/389
nct id: NCT03791762
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In an ideal endodontic treatment, maintenance of the original root canal morphology of the
      canal during root canal preparation, an ideal preparation and obturation is essential. Even
      if all stages are ideal, pain after endodontic treatment is a clinical condition that may
      occur after a few hours or several days. Post-operative pain after endodontic treatment is an
      undesirable condition which makes the clinician and the patient a distressing condition. Many
      clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which
      means that postoperative pain is a clinical symptom that should be considered for
      endodontist.

      The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary
      motion, and their center of mass or center of rotation is positioned off-center relative to
      the instrument's central axis of rotation. During rotation, the files of this design produce
      a mechanical wave of motion, which travels along the length of the working part of the
      instrument, minimizing the contact between the file and dentin. According to the
      manufacturer, the offset design of this instrument also improves debris removal and
      flexibility in the working part of the file.

      New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility
      and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a
      new thermal treatment called Gold treatment, was introduced on the market presenting some
      differences in design, size and taper compared to Wave One. Wave One Gold instrument has a
      parallelogram cross-sectional design, having two cutting edges, and consists of four
      instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One
      presents convex triangular cross-sectional design, besides larger size and taper.

      Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest
      version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges,
      and a noncutting tip. However, REB files are manufactured by altering the molecular structure
      through a new heat treatment in order to increase the cyclic fatigue resistance. This new
      heat treatment gives the file its blue color. It was reported that REB files have
      approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files
      can also be relatively prebent to better access curved canals.

      However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the
      postoperative endodontic pain has not been investigated, yet. The aim of this prospective
      clinical trial was to clinically compare the incidence of postoperative pain after use of
      different nickel titanium file systems. The purpose of the present study was to evaluate the
      incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper
      Next, Waveone Gold. The null hypothesis tested was that there is no difference in the
      incidence and severity of postoperative pain following with any of the 3 instruments.
In the study, 180 patients who were diagnosed with asymptomatic irreversible pulpitis,
      symptomatic irreversible pulpitis, acute apical periodontitis and chronic apical
      periodontitis, and who applied to the Endodontics clinic for inclusion in the endodontics
      clinic will be included. A female with systemic healthy patients who meet the inclusion
      criteria will be treated clinically and radiologically. The age and gender of the patient
      will be recorded as patient-dependent variables, and location and type of the tooth to be
      treated will be recorded as tooth-dependent variables. Before the root canal treatment, the
      responsible researcher will provide training on patients with the Vizual Analog Scale (VAS)
      and its use. Root canal treatments will be completed by this responsible investigator. Before
      starting root canal treatment, local anesthesia will be applied using 2: Lidocaine anesthetic
      solution containing 2: 80,000 epinephrine using the appropriate technique to the tooth. After
      anesthesia is provided, endodontic access cavities suitable for the teeth will be opened. The
      pulp tissue will be extruded using a turner. Subsequently, according to the entry path file
      to be used, the subjects will be assigned to the group that is selected from the closed
      envelopes that write the names of the groups, and random manual preparation will be divided
      into 3 groups: the R-Pilot file will be used, the rotation preparation will be used, and the
      ProGlider file will be used (n = 60). Working lengths will be determined by using K type file
      10 and electronic apex finders. The manual preparation group will serve as the control group.
      In this group, K type hand files (Dentsply Sirona) # 08, 10, 15, respectively, will be used
      with the "forward and retract" technique proposed by Ruddle at the working length. The file
      will be moved clockwise and then counterclockwise, by rotating quarterly, the resistance will
      be advanced and retracted to the point where resistance is felt in the canal. This
      preparation will be made with each file until the working length is reached. In the rotation
      group where ProGlider file will be used, the entry way will be prepared at 300 rpm and 5 Ncm
      torque values using the torque-controlled endodontic motor (X-Smart) until the working length
      is reached with the crown-down technique. In the reciprocating movement group where the
      R-Pilot file will be used, the entry path will be prepared using the "Reciproc All" mode in
      the VDW-Silver endodontic engine. After the entryway preparation, standard procedures will be
      performed for all three groups. The channels will be prepared with ProTaper Next file system.
      During treatment, 10 mL of 5% NaOCl irrigation for each channel will be done using a 30-G
      irrigation needle. After the preparation, final irrigation will be done with 17% EDTA,
      distilled water and 5% NaOCl, respectively. In the samples in all three groups, after the
      root canals are dried with sterile paper cone, they will be filled with cold Plus lateral
      compaction technique with AH Plus canal paste and gutta percha cone. Patients' phone numbers
      will be taken, a copy of the VAS form will be delivered to the patients to be filled in, and
      it will be explained that postoperative pain measurements will be made with 6, 12, 18, 24, 36
      and 48 hours of VAS. Patients will be reached by phone 48 hours after the completion of root
      canal treatments and information about their pain levels will be received. VAS values will be
      classified as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-10, severe pain. The
      use of analgesics will also be evaluated and recorded within the first 48 hours.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Treatment
masking: Single (Investigator)
measure: Postoperative Pain Scores using Visual Analogue Scale
time frame: 72 hours
description: Visual analogue scale is a measure of pain intensity. In the present study, the visual analogue scale included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity and a worse outcome. 1-3 means "mild pain", 4-6 means "moderate pain" and 7-9 means "severe pain". There are no subscales.
arm group label: WaveOne Gold
arm group type: Experimental
description: Root canal preparation with WaveOne Gold instrumentation system in a reciprocating manner
arm group label: Reciproc Blue
arm group type: Experimental
description: Root canal preparation with Reciproc Blue instrumentation system in a reciprocating manner
arm group label: ProTaper Next
arm group type: Experimental
description: Root canal preparation with ProTaper Next instrumentation system in a rotating manner
intervention type: Procedure
intervention name: WaveOne Gold
description: WaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at "WaveOne ALL" setting.
arm group label: WaveOne Gold
other name: Reciprocating root canal preparation instruments
other name: Dentsply Sirona, Ballaigues, Switzerland
intervention type: Procedure
intervention name: Reciproc Blue
description: Reciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at "Reciproc ALL" setting.
arm group label: Reciproc Blue
other name: Reciprocating root canal preparation instruments
other name: VDW, Munich, Germany
intervention type: Procedure
intervention name: ProTaper Next
description: ProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm).
arm group label: ProTaper Next
other name: Rotating root canal preparation instrument
other name: Dentsply Sirona, Ballaigues, Switzerland
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ondokuz Mayıs University
investigator full name: Cangül Keskin
investigator title: Doctor
mesh term: Pain, Postoperative
mesh term: Polymethyl Methacrylate