<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/NCT03792217</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO-CU-2011-7-25</org_study_id>
    <nct_id>NCT03792217</nct_id>
  </id_info>
  <brief_title>Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite</brief_title>
  <official_title>Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%&#xD;
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative&#xD;
      pain and medication intake in adult patients with pulp necrosis in mandibular molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%&#xD;
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative&#xD;
      pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical&#xD;
      and dental history was obtained from all participants in this trial and clinical and&#xD;
      radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or&#xD;
      without apical periodontitis were included. After access cavity preparation, participants&#xD;
      were randomly assigned to one of the following groups: experimental group (irrigation using&#xD;
      1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment&#xD;
      was performed with a week interval in between visits. Each patient received a 7-day diary to&#xD;
      record postoperative pain and rescue medication intake. Post-operative pain was measured at&#xD;
      the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and&#xD;
      postobturation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2011</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>immediately after treatment</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>3 hours</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>48 hours</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>7 days</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain using a pain-measuring scale</measure>
    <time_frame>immediately after obturation</time_frame>
    <description>Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sham medication intake incidence</measure>
    <time_frame>7 days</time_frame>
    <description>Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic medication intake incidence</measure>
    <time_frame>7 days</time_frame>
    <description>Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>Dental Pulp Necrosis</condition>
  <arm_group>
    <arm_group_label>1.3% NaOCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal irrigation done using 1.3% NaOCl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5.25% NaOCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal irrigation done using 5.25% NaOCl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1.3% NaOCl</intervention_name>
    <description>Endodontic irrigant</description>
    <arm_group_label>1.3% NaOCl</arm_group_label>
    <other_name>1.3% sodium hypochlorite</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5.25% NaOCl</intervention_name>
    <description>Endodontic irrigant</description>
    <arm_group_label>5.25% NaOCl</arm_group_label>
    <other_name>5.25% sodium hypochlorite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 25-45 year old.&#xD;
&#xD;
          2. Medically free.&#xD;
&#xD;
          3. Non-vital mandibular teeth (first or second molar) with or without apical&#xD;
             periodontitis&#xD;
&#xD;
          4. No sex predilection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant females.&#xD;
&#xD;
          2. History of allergy to any medication used in the study.&#xD;
&#xD;
          3. Preoperative premedication 12 hours before procedure.&#xD;
&#xD;
          4. Acute abscess cases.&#xD;
&#xD;
          5. Badly-decayed crown.&#xD;
&#xD;
          6. Retreatment cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzan Amin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Randa El-Boghdady, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <reference>
    <citation>Almeida G, Marques E, De Martin AS, da Silveira Bueno CE, Nowakowski A, Cunha RS. Influence of irrigating solution on postoperative pain following single-visit endodontic treatment: randomized clinical trial. J Can Dent Assoc. 2012;78:c84.</citation>
    <PMID>22985896</PMID>
  </reference>
  <reference>
    <citation>Bashetty K, Hegde J. Comparison of 2% chlorhexidine and 5.25% sodium hypochlorite irrigating solutions on postoperative pain: a randomized clinical trial. Indian J Dent Res. 2010 Oct-Dec;21(4):523-7. doi: 10.4103/0970-9290.74225.</citation>
    <PMID>21187618</PMID>
  </reference>
  <reference>
    <citation>Farzaneh S, Parirokh M, Nakhaee N, Abbott PV. Effect of two different concentrations of sodium hypochlorite on postoperative pain following single-visit root canal treatment: a triple-blind randomized clinical trial. Int Endod J. 2018 Jan;51 Suppl 1:e2-e11. doi: 10.1111/iej.12749. Epub 2017 Mar 6.</citation>
    <PMID>28134983</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 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>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Suzan AW Amin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Hypochlorite</mesh_term>
    <mesh_term>Eusol</mesh_term>
  </intervention_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/NCT03792217
org study id: ENDO-CU-2011-7-25
nct id: NCT03792217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative
      pain and medication intake in adult patients with pulp necrosis in mandibular molars.
The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative
      pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical
      and dental history was obtained from all participants in this trial and clinical and
      radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or
      without apical periodontitis were included. After access cavity preparation, participants
      were randomly assigned to one of the following groups: experimental group (irrigation using
      1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment
      was performed with a week interval in between visits. Each patient received a 7-day diary to
      record postoperative pain and rescue medication intake. Post-operative pain was measured at
      the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and
      postobturation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative pain using a pain-measuring scale
time frame: immediately after treatment
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit
measure: Postoperative pain using a pain-measuring scale
time frame: 3 hours
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit
measure: Postoperative pain using a pain-measuring scale
time frame: 24 hours
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
measure: Postoperative pain using a pain-measuring scale
time frame: 48 hours
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
measure: Postoperative pain using a pain-measuring scale
time frame: 7 days
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
measure: Postoperative pain using a pain-measuring scale
time frame: immediately after obturation
description: Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation.
measure: Sham medication intake incidence
time frame: 7 days
description: Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
measure: Analgesic medication intake incidence
time frame: 7 days
description: Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
arm group label: 1.3% NaOCl
arm group type: Experimental
description: Root canal irrigation done using 1.3% NaOCl.
arm group label: 5.25% NaOCl
arm group type: Active Comparator
description: Root canal irrigation done using 5.25% NaOCl.
intervention type: Other
intervention name: 1.3% NaOCl
description: Endodontic irrigant
arm group label: 1.3% NaOCl
other name: 1.3% sodium hypochlorite
intervention type: Other
intervention name: 5.25% NaOCl
description: Endodontic irrigant
arm group label: 5.25% NaOCl
other name: 5.25% sodium hypochlorite
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
last name: Suzan Amin, PhD
role: Study Director
affiliation: Cairo University
last name: Randa El-Boghdady, PhD
role: Study Chair
affiliation: Cairo University
citation: Almeida G, Marques E, De Martin AS, da Silveira Bueno CE, Nowakowski A, Cunha RS. Influence of irrigating solution on postoperative pain following single-visit endodontic treatment: randomized clinical trial. J Can Dent Assoc. 2012;78:c84.
PMID: 22985896
citation: Bashetty K, Hegde J. Comparison of 2% chlorhexidine and 5.25% sodium hypochlorite irrigating solutions on postoperative pain: a randomized clinical trial. Indian J Dent Res. 2010 Oct-Dec;21(4):523-7. doi: 10.4103/0970-9290.74225.
PMID: 21187618
citation: Farzaneh S, Parirokh M, Nakhaee N, Abbott PV. Effect of two different concentrations of sodium hypochlorite on postoperative pain following single-visit root canal treatment: a triple-blind randomized clinical trial. Int Endod J. 2018 Jan;51 Suppl 1:e2-e11. doi: 10.1111/iej.12749. Epub 2017 Mar 6.
PMID: 28134983
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Suzan AW Amin
investigator title: Professor
mesh term: Dental Pulp Necrosis
mesh term: Pain, Postoperative
mesh term: Necrosis
mesh term: Sodium Hypochlorite
mesh term: Eusol
sharing ipd: No