<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/NCT03285334</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-19</org_study_id>
    <nct_id>NCT03285334</nct_id>
  </id_info>
  <brief_title>3D Instrumentation Versus Rotary Instrumentation</brief_title>
  <official_title>The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed&#xD;
      consent.&#xD;
&#xD;
      allocation of the patient to either intervention or control group. After anaesthesia and&#xD;
      access cavity, the first root canal sample will be taken. Endodontic treatment will be&#xD;
      completed in one visit. The second root canal sample will be taken. Patients will be asked to&#xD;
      evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5&#xD;
      days. Patients will record the number of analgesics if any taken.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient&#xD;
      conforms to all eligibility criteria, (R.S) will enroll the patient in the study.&#xD;
&#xD;
      the operator will complete treatment of all cases in single visit as following:&#xD;
&#xD;
        1. Anesthetizing the tooth using inferior alveolar nerve block technique&#xD;
&#xD;
        2. Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam&#xD;
           will be applied.&#xD;
&#xD;
        3. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z&#xD;
           bur .&#xD;
&#xD;
        4. (R.S) will take the preinstrumentation root canal sample (S1)&#xD;
&#xD;
        5. Confirming the patency of the root canals using stainless steel hand K-files size #10&#xD;
           and #15 . Working length will be determined .&#xD;
&#xD;
        6. In the intervention group, (R.S) will perform mechanical preparation in a 3D manner&#xD;
           using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a&#xD;
           torque of 1 Ncm.&#xD;
&#xD;
        7. In the control group, mechanical preparation will be done using rotary iRace files&#xD;
           (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The&#xD;
           canal will be irrigated and recapitulated after the use of each instrument.&#xD;
&#xD;
        8. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml&#xD;
           of 2.5% sodium hypochlorite.&#xD;
&#xD;
        9. The canal will then be dried by using sterile paper points and then flushed with 5 ml of&#xD;
           5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will&#xD;
           be taken from the canals.&#xD;
&#xD;
       10. Master cones will be fitted to the working length and a radiograph will be taken to&#xD;
           ensure proper length.&#xD;
&#xD;
       11. (R.S) will complete obturation using AdSeal resin-based root canal sealer .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">February 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patients will drag an envelope and will not know to which group they will be assigned.&#xD;
The patients who already do not know their treatment group will assess the level of their post-operative pain and will record the number of analgesic tablets used.&#xD;
The laboratory technician at the microbiological department will not know the treatment group of the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Degree of postoperative pain will be measured by the patients using modified VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intracanal bacterial reduction</measure>
    <time_frame>6 hours</time_frame>
    <description>The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically.&#xD;
The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of analgesic intake</measure>
    <time_frame>up to 5 days</time_frame>
    <description>In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>XP-endo Shaper</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iRace</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rotary files</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XP-endo Shaper</intervention_name>
    <description>mechanical preparation in a 3D manner using Xp-endo Shaper</description>
    <arm_group_label>XP-endo Shaper</arm_group_label>
    <other_name>anatomical (3D) shaping file</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iRace files</intervention_name>
    <description>rotary mechanical preparation</description>
    <arm_group_label>iRace</arm_group_label>
    <other_name>rotary files</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy Adult patients.&#xD;
&#xD;
          2. Age between 20-40 years old.&#xD;
&#xD;
          3. Males &amp; Females.&#xD;
&#xD;
          4. Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.&#xD;
&#xD;
          5. Normal occlusal contact with the opposing teeth.&#xD;
&#xD;
          6. Patients accepting to participate in the study.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Medically compromised patients&#xD;
&#xD;
          2. Pregnant women&#xD;
&#xD;
          3. If analgesics or antibiotics have been administrated by the patient during the past 12&#xD;
             hours preoperatively&#xD;
&#xD;
          4. Patients reporting bruxism or clenching&#xD;
&#xD;
          5. Teeth that shows:&#xD;
&#xD;
               -  Association with acute periapical abscess and swelling&#xD;
&#xD;
               -  Greater than grade I mobility or pocket depth greater than 5mm&#xD;
&#xD;
               -  No restorability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radwa Emara</last_name>
    <role>Principal Investigator</role>
    <affiliation>faculty of oral and dental medicine - cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>radwa emara</last_name>
    <phone>01272141312</phone>
    <email>radwa.emara@dentistry.cu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine - Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Manial</state>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Radwa Emara</last_name>
      <phone>01272141312</phone>
      <email>radwa.emara@dentistry.cu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Radwa Sameeh Emara</investigator_full_name>
    <investigator_title>assisstant lecturer</investigator_title>
  </responsible_party>
  <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/NCT03285334
org study id: CEBD-CU-2017-09-19
nct id: NCT03285334
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed
      consent.

      allocation of the patient to either intervention or control group. After anaesthesia and
      access cavity, the first root canal sample will be taken. Endodontic treatment will be
      completed in one visit. The second root canal sample will be taken. Patients will be asked to
      evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5
      days. Patients will record the number of analgesics if any taken.
After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient
      conforms to all eligibility criteria, (R.S) will enroll the patient in the study.

      the operator will complete treatment of all cases in single visit as following:

        1. Anesthetizing the tooth using inferior alveolar nerve block technique

        2. Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam
           will be applied.

        3. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z
           bur .

        4. (R.S) will take the preinstrumentation root canal sample (S1)

        5. Confirming the patency of the root canals using stainless steel hand K-files size #10
           and #15 . Working length will be determined .

        6. In the intervention group, (R.S) will perform mechanical preparation in a 3D manner
           using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a
           torque of 1 Ncm.

        7. In the control group, mechanical preparation will be done using rotary iRace files
           (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The
           canal will be irrigated and recapitulated after the use of each instrument.

        8. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml
           of 2.5% sodium hypochlorite.

        9. The canal will then be dried by using sterile paper points and then flushed with 5 ml of
           5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will
           be taken from the canals.

       10. Master cones will be fitted to the working length and a radiograph will be taken to
           ensure proper length.

       11. (R.S) will complete obturation using AdSeal resin-based root canal sealer .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The patients will drag an envelope and will not know to which group they will be assigned.
The patients who already do not know their treatment group will assess the level of their post-operative pain and will record the number of analgesic tablets used.
The laboratory technician at the microbiological department will not know the treatment group of the patients.
measure: Postoperative Pain
time frame: up to 5 days
description: Degree of postoperative pain will be measured by the patients using modified VAS
measure: intracanal bacterial reduction
time frame: 6 hours
description: The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically.
The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample.
measure: Incidence of analgesic intake
time frame: up to 5 days
description: In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)
arm group label: XP-endo Shaper
arm group type: Experimental
description: The XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.
arm group label: iRace
arm group type: Active Comparator
description: rotary files
intervention type: Device
intervention name: XP-endo Shaper
description: mechanical preparation in a 3D manner using Xp-endo Shaper
arm group label: XP-endo Shaper
other name: anatomical (3D) shaping file
intervention type: Device
intervention name: iRace files
description: rotary mechanical preparation
arm group label: iRace
other name: rotary files
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Radwa Emara
role: Principal Investigator
affiliation: faculty of oral and dental medicine - cairo university
last name: radwa emara
phone: 01272141312
email: radwa.emara@dentistry.cu.edu.eg
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Radwa Sameeh Emara
investigator title: assisstant lecturer
mesh term: Pain, Postoperative
sharing ipd: No