<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/NCT03749408</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2012-12-24</org_study_id>
    <nct_id>NCT03749408</nct_id>
  </id_info>
  <brief_title>Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain</brief_title>
  <official_title>Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: 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>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol&#xD;
      in patients with irreversible pulpitis in mandibular molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with irreversible pulpitis in mandibular molars will be selected according to the&#xD;
      eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone&#xD;
      or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain</measure>
    <time_frame>6 hours</time_frame>
    <description>using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain</measure>
    <time_frame>12 hours</time_frame>
    <description>using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain</measure>
    <time_frame>24 hours</time_frame>
    <description>using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain</measure>
    <time_frame>48 hours</time_frame>
    <description>using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain</measure>
    <time_frame>72 hours</time_frame>
    <description>using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anesthetic success</measure>
    <time_frame>1 hour</time_frame>
    <description>yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lip numbness duration</measure>
    <time_frame>24 hours</time_frame>
    <description>recorded in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication intake</measure>
    <time_frame>72 hours</time_frame>
    <description>yes or no</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Irreversible Pulpitis</condition>
  <arm_group>
    <arm_group_label>bupivacaine plus mannitol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% bupivacaine with 1:200,000epinephrine alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine plus mannitol</intervention_name>
    <description>local anesthesia</description>
    <arm_group_label>bupivacaine plus mannitol</arm_group_label>
    <other_name>vivacaine plus mannitol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine alone</intervention_name>
    <description>local anesthesia</description>
    <arm_group_label>bupivacaine alone</arm_group_label>
    <other_name>vivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients; age between 17-35 years old.&#xD;
&#xD;
          2. Males or Females.&#xD;
&#xD;
          3. Medically-free patients&#xD;
&#xD;
          4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis&#xD;
             in mandibular molar teeth.&#xD;
&#xD;
          5. Positive patients' acceptance for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had any analgesic during proceeding 12 hours before the treatment.&#xD;
&#xD;
          -  Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis&#xD;
             (apical abscess).&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Patients with history of significant medical conditions (contraindication of mannitol&#xD;
             use).&#xD;
&#xD;
          -  Addiction&#xD;
&#xD;
          -  Psycological disturbance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Safeya AbdelRahaman Hassan</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>inferior alveolar nerve block</keyword>
  <keyword>long-acting local anesthesia</keyword>
  <keyword>bupivacaine</keyword>
  <keyword>mannitol</keyword>
  <keyword>symptomatic irreversible pulpitits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03749408
org study id: CEBD-CU-2012-12-24
nct id: NCT03749408
lead sponsor: 
has dmc: No
is fda regulated device: No
Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol
      in patients with irreversible pulpitis in mandibular molars.
Patients with irreversible pulpitis in mandibular molars will be selected according to the
      eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone
      or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
time frame: 6 hours
description: using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
time frame: 12 hours
description: using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
time frame: 24 hours
description: using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
time frame: 48 hours
description: using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
time frame: 72 hours
description: using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
measure: Anesthetic success
time frame: 1 hour
description: yes or no
measure: lip numbness duration
time frame: 24 hours
description: recorded in hours
measure: Medication intake
time frame: 72 hours
description: yes or no
arm group label: bupivacaine plus mannitol
arm group type: Active Comparator
description: 0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol
arm group label: bupivacaine alone
arm group type: Experimental
description: 0.5% bupivacaine with 1:200,000epinephrine alone
intervention type: Drug
intervention name: bupivacaine plus mannitol
description: local anesthesia
arm group label: bupivacaine plus mannitol
other name: vivacaine plus mannitol
intervention type: Drug
intervention name: bupivacaine alone
description: local anesthesia
arm group label: bupivacaine alone
other name: vivacaine
criteria: 
gender: All
minimum age: 17 Years
maximum age: 35 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Safeya AbdelRahaman Hassan
investigator title: assistant lecturer
mesh term: Pulpitis
mesh term: Mannitol
mesh term: Bupivacaine
sharing ipd: No