<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/NCT03015987</url>
  </required_header>
  <id_info>
    <org_study_id>laser_ultrasonic</org_study_id>
    <nct_id>NCT03015987</nct_id>
  </id_info>
  <brief_title>Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth</brief_title>
  <official_title>The Effect of Diode Laser Activated Irrigation Versus Ultrasonic Activated Irrigation on Post-Operative Pain in Single Visit Endodontic Treatment of Asymptomatic Necrotic Teeth: A Randomized Controlled 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigator intended to study the effect of laser versus ultrasonic in activation of&#xD;
      irrigation in post operative pain of patients have a symptomatic necrotic teeth&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the investigator will choose from patients entering clinic of endodontics in faculty of oral&#xD;
      and dental medicine Cairo university who are eligible to the criteria.&#xD;
&#xD;
      After the patients is found eligible,the patients will be randomly assigned to either the&#xD;
      control (ultrasonic activated irrigation )or to the intervention ( diode laser activated&#xD;
      irrigation) treatment done in both in single visit.&#xD;
&#xD;
      At the end of treatment, patients will be asked to record post operative pain by NRS .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">January 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>
  </study_design_info>
  <primary_outcome>
    <measure>post operative pain</measure>
    <time_frame>up to 1 week</time_frame>
    <description>intensity of post operative pain will be measured using a numerical rating (NRS)scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Necrosis</condition>
  <arm_group>
    <arm_group_label>diode laser activated irrigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ultrasonic activated irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant.&#xD;
Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diode laser activated irrigation</intervention_name>
    <description>diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that</description>
    <arm_group_label>diode laser activated irrigation</arm_group_label>
    <arm_group_label>ultrasonic activated irrigation</arm_group_label>
    <other_name>diode laser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic necrotic single rooted single canal teeth with or without chronic&#xD;
             periradicular lesion.&#xD;
&#xD;
          -  Teeth with mature root&#xD;
&#xD;
          -  Teeth without calcified root canals&#xD;
&#xD;
          -  Teeth without root caries&#xD;
&#xD;
          -  Teeth without internal or external root resorption&#xD;
&#xD;
          -  Teeth with no sign of crack formation&#xD;
&#xD;
          -  Teeth without anatomic abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Teeth with vital pulp&#xD;
&#xD;
          -  Non- restorable teeth&#xD;
&#xD;
          -  Medically compromised patients&#xD;
&#xD;
          -  Patients with facial swelling or acute infection.&#xD;
&#xD;
          -  Previously endodontically treated teeth&#xD;
&#xD;
          -  periodontally affected teeth&#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>Ghada A Eid, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa M El shinawy, Researcher professor</last_name>
    <role>Study Director</role>
    <affiliation>Surgery &amp;oral medicine department -National Research Institute-Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zeinab M Omar, Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zeinab M Omar, student</last_name>
    <phone>01017111154</phone>
    <email>dentistonline89@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ghada A Eid, Professor</last_name>
    <phone>01001266608</phone>
    <email>ghada.eid@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>1-Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 41:91-9. 2-.Ng YL, Glennon JP, Setchell DJ. Prevalence of and factors affecting post. obturation pain in patients undergoing root canal treatment. Int Endod J 2004;37:381-91. 3-Peters OA. Current challenges and concepts in the preparation of root canal systems a review. J Endod 2004; 30:559-67. 4- Gu L, Kim JR, Ling J. Review of contemporary irrigant agitation techniques and devices. J Endod 2009; 35:791-804.</citation>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>zeinab mostafa omar</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Diode laser</keyword>
  <keyword>asymptomatic pulp</keyword>
  <keyword>Laser activated irrigation</keyword>
  <keyword>continuous ultrasonic activation</keyword>
  <keyword>post obturation pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03015987
org study id: laser_ultrasonic
nct id: NCT03015987
lead sponsor: 
has dmc: No
the investigator intended to study the effect of laser versus ultrasonic in activation of
      irrigation in post operative pain of patients have a symptomatic necrotic teeth
the investigator will choose from patients entering clinic of endodontics in faculty of oral
      and dental medicine Cairo university who are eligible to the criteria.

      After the patients is found eligible,the patients will be randomly assigned to either the
      control (ultrasonic activated irrigation )or to the intervention ( diode laser activated
      irrigation) treatment done in both in single visit.

      At the end of treatment, patients will be asked to record post operative pain by NRS .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: post operative pain
time frame: up to 1 week
description: intensity of post operative pain will be measured using a numerical rating (NRS)scale
arm group label: diode laser activated irrigation
arm group type: Experimental
description: Laser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics.
arm group label: ultrasonic activated irrigation
arm group type: Active Comparator
description: ultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant.
Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl.
intervention type: Other
intervention name: diode laser activated irrigation
description: diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that
arm group label: diode laser activated irrigation
arm group label: ultrasonic activated irrigation
other name: diode laser
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ghada A Eid, Professor
role: Study Chair
affiliation: Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
last name: Hanaa M El shinawy, Researcher professor
role: Study Director
affiliation: Surgery &oral medicine department -National Research Institute-Cairo University
last name: Zeinab M Omar, Student
role: Principal Investigator
affiliation: Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
last name: Zeinab M Omar, student
phone: 01017111154
email: dentistonline89@yahoo.com
last name: Ghada A Eid, Professor
phone: 01001266608
email: ghada.eid@dentistry.cu.edu.eg
citation: 1-Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 41:91-9. 2-.Ng YL, Glennon JP, Setchell DJ. Prevalence of and factors affecting post. obturation pain in patients undergoing root canal treatment. Int Endod J 2004;37:381-91. 3-Peters OA. Current challenges and concepts in the preparation of root canal systems a review. J Endod 2004; 30:559-67. 4- Gu L, Kim JR, Ling J. Review of contemporary irrigant agitation techniques and devices. J Endod 2009; 35:791-804.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: zeinab mostafa omar
investigator title: principal investigator
mesh term: Pain, Postoperative
mesh term: Necrosis
sharing ipd: No