<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/NCT02984488</url>
  </required_header>
  <id_info>
    <org_study_id>single_two visits</org_study_id>
    <nct_id>NCT02984488</nct_id>
  </id_info>
  <brief_title>Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next</brief_title>
  <official_title>Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the incidence and severity of postoperative pain after root canal therapy of&#xD;
      necrotic teeth in one appointment versus two appointments using Protaper next instrument.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The key to endodontic success was described as the debridement and neutralization of any&#xD;
      tissue, bacteria, or inflammatory products within the root canal system.&#xD;
&#xD;
      Endodontic treatment used to take multiple visits to complete, with one of the main reasons&#xD;
      for this being that it required a considerable amount of time to complete the treatment.&#xD;
&#xD;
      The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of&#xD;
      diathermy for pulpal disinfection and hydrogen peroxide for irrigation.&#xD;
&#xD;
      The use of contemporary endodontic techniques and equipment, such as use of rubber dam,&#xD;
      magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and&#xD;
      so forth, not only increases the success rate of endodontic treatment but also, shortens the&#xD;
      time needed for the treatment. Endodontic treatment may therefore be completed in a single&#xD;
      visit.&#xD;
&#xD;
      It is generally agreed upon that the prepared canals can never be sterile before obturation,&#xD;
      no matter how potent the antibacterial irrigants or intracanal medications are. There are&#xD;
      currently two measures to reduce bacterial persistence and reinfection in the canals. We can&#xD;
      either dress the canals with antibacterial agents in multiple visits or immediately obturate&#xD;
      the canals, to reduce the space for bacterial colonization, in a single-visit approach.&#xD;
      Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy&#xD;
      towards Enterococcus faecalis is questionable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of post operative pain.</measure>
    <time_frame>After 6-12-24-48 hours from the obturation step of the endodontic treatment.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tooth, Nonvital</condition>
  <arm_group>
    <arm_group_label>single visit endodontic treatment.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>•single visit endodontic Treatment of necrotic teeth using Protaper next.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two visits endodontic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>•Two visits endodontic Treatment of necrotic teeth using Protaper next.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>single visits</intervention_name>
    <description>Endodontic treatment is done and completed in a single visit using protaper next rotary system.</description>
    <arm_group_label>single visit endodontic treatment.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>two visits</intervention_name>
    <description>Endodontic treatment is done and completed in two visits using protaper next rotary system.</description>
    <arm_group_label>Two visits endodontic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Medically free patients.&#xD;
&#xD;
          -  Patient's age above 18 years old.&#xD;
&#xD;
          -  Teeth diagnosed clinically with necrosis.&#xD;
&#xD;
          -  Positive patient's acceptance for participation in the study.&#xD;
&#xD;
          -  Sex includes both male and female.&#xD;
&#xD;
          -  Patients who can understand visual analogue scale.&#xD;
&#xD;
          -  Patients able to sign informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Medically compromised patients.&#xD;
&#xD;
          -  Patient with multiple teeth that required treatment in the same quadrant to eliminate&#xD;
             the possibility of pain referral.&#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>Saeed M Abd El aziz, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of endodontics - Faculty of Oral and Dental medicine - CU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>hebatallah M nada, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of endodontics - Faculty of Oral and Dental medicine - CU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hebatallah M nada, student</last_name>
    <phone>o1112393619</phone>
    <email>dr_heba_nada@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abeer sabi, lecturer</last_name>
    <phone>01001192266</phone>
  </overall_contact_backup>
  <reference>
    <citation>Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.</citation>
    <PMID>24876699</PMID>
  </reference>
  <reference>
    <citation>DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.</citation>
    <PMID>12075212</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hebatallah Mostafa Mahmoud Ahmed Nada</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>necrotic teeth</keyword>
  <keyword>single visit</keyword>
  <keyword>multiple visits</keyword>
  <keyword>protaper next</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Nonvital</mesh_term>
    <mesh_term>Necrosis</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/NCT02984488
org study id: single_two visits
nct id: NCT02984488
lead sponsor: 
has dmc: No
To evaluate the incidence and severity of postoperative pain after root canal therapy of
      necrotic teeth in one appointment versus two appointments using Protaper next instrument.
The key to endodontic success was described as the debridement and neutralization of any
      tissue, bacteria, or inflammatory products within the root canal system.

      Endodontic treatment used to take multiple visits to complete, with one of the main reasons
      for this being that it required a considerable amount of time to complete the treatment.

      The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of
      diathermy for pulpal disinfection and hydrogen peroxide for irrigation.

      The use of contemporary endodontic techniques and equipment, such as use of rubber dam,
      magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and
      so forth, not only increases the success rate of endodontic treatment but also, shortens the
      time needed for the treatment. Endodontic treatment may therefore be completed in a single
      visit.

      It is generally agreed upon that the prepared canals can never be sterile before obturation,
      no matter how potent the antibacterial irrigants or intracanal medications are. There are
      currently two measures to reduce bacterial persistence and reinfection in the canals. We can
      either dress the canals with antibacterial agents in multiple visits or immediately obturate
      the canals, to reduce the space for bacterial colonization, in a single-visit approach.
      Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy
      towards Enterococcus faecalis is questionable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of post operative pain.
time frame: After 6-12-24-48 hours from the obturation step of the endodontic treatment.
arm group label: single visit endodontic treatment.
arm group type: Experimental
description: •single visit endodontic Treatment of necrotic teeth using Protaper next.
arm group label: Two visits endodontic treatment
arm group type: Active Comparator
description: •Two visits endodontic Treatment of necrotic teeth using Protaper next.
intervention type: Procedure
intervention name: single visits
description: Endodontic treatment is done and completed in a single visit using protaper next rotary system.
arm group label: single visit endodontic treatment.
intervention type: Procedure
intervention name: two visits
description: Endodontic treatment is done and completed in two visits using protaper next rotary system.
arm group label: Two visits endodontic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Saeed M Abd El aziz, professor
role: Study Chair
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
last name: hebatallah M nada, student
role: Principal Investigator
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
last name: hebatallah M nada, student
phone: o1112393619
email: dr_heba_nada@hotmail.com
last name: Abeer sabi, lecturer
phone: 01001192266
citation: Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.
PMID: 24876699
citation: DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.
PMID: 12075212
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hebatallah Mostafa Mahmoud Ahmed Nada
investigator title: principal investigator
mesh term: Tooth, Nonvital
mesh term: Necrosis
sharing ipd: No