<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/NCT02226913</url>
  </required_header>
  <id_info>
    <org_study_id>193396</org_study_id>
    <nct_id>NCT02226913</nct_id>
  </id_info>
  <brief_title>Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis</brief_title>
  <official_title>Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masoud Saatchi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control.&#xD;
      The purpose of this prospective, randomized, double-blind study was to evaluate the effect of&#xD;
      adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on&#xD;
      the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic&#xD;
      irreversible pulpitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten&#xD;
      the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering&#xD;
      of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and&#xD;
      improve success rate of anesthesia. There are no studies evaluating a sodium&#xD;
      bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible&#xD;
      pulpitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Local Anesthesia</condition>
  <arm_group>
    <arm_group_label>lidocaine &amp; sodium bicarbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lidocaine &amp; placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% lidocaine with 1:80,000 epinephrine</intervention_name>
    <description>2% lidocaine with 1:80,000 epinephrine</description>
    <arm_group_label>lidocaine &amp; placebo</arm_group_label>
    <arm_group_label>lidocaine &amp; sodium bicarbonate</arm_group_label>
    <other_name>Lignospan; Septodont, Saint Maur des Fosses, France</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium bicarbonate</intervention_name>
    <description>8.4% sodium bicarbonate</description>
    <arm_group_label>lidocaine &amp; sodium bicarbonate</arm_group_label>
    <other_name>Samen Laboratories (Mashhad, Iran)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>sterile distilled water (Samen Pharmaceutical Co, Iran)</description>
    <arm_group_label>lidocaine &amp; placebo</arm_group_label>
    <other_name>sterile distilled water (Samen Pharmaceutical Co, Iran)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  vital mandibular molar tooth&#xD;
&#xD;
          -  diagnosis of symptomatic irreversible pulpitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years old&#xD;
&#xD;
          -  history of significant medical conditions&#xD;
&#xD;
          -  allergies to local anesthetics or sulfites&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  taking any medications that might influence anesthetic assessment&#xD;
&#xD;
          -  active sites of pathosis in area of injection&#xD;
&#xD;
          -  inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masoud Saatchi, DDS MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Isfahan University of Medical Sciences</affiliation>
  </overall_official>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Masoud Saatchi</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>Buffered</keyword>
  <keyword>inferior alveolar nerve block</keyword>
  <keyword>irreversible pulpitis</keyword>
  <keyword>local anesthesia</keyword>
  <keyword>sodium bicarbonate</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>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</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/NCT02226913
org study id: 193396
nct id: NCT02226913
lead sponsor: 
has dmc: Yes
Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control.
      The purpose of this prospective, randomized, double-blind study was to evaluate the effect of
      adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on
      the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic
      irreversible pulpitis.
Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten
      the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering
      of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and
      improve success rate of anesthesia. There are no studies evaluating a sodium
      bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible
      pulpitis.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Participant, Investigator)
measure: Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
time frame: Baseline
measure: Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
time frame: Baseline
arm group label: lidocaine & sodium bicarbonate
arm group type: Experimental
description: 2% lidocaine with 1: 80,000 epinephrine buffered with 0.18 mL of 8.4% sodium bicarbonate
arm group label: lidocaine & placebo
arm group type: Active Comparator
description: 2% lidocaine with 1:80,000 epinephrine with 0.18 mL of sterile distilled water
intervention type: Drug
intervention name: 2% lidocaine with 1:80,000 epinephrine
description: 2% lidocaine with 1:80,000 epinephrine
arm group label: lidocaine & placebo
arm group label: lidocaine & sodium bicarbonate
other name: Lignospan; Septodont, Saint Maur des Fosses, France
intervention type: Drug
intervention name: sodium bicarbonate
description: 8.4% sodium bicarbonate
arm group label: lidocaine & sodium bicarbonate
other name: Samen Laboratories (Mashhad, Iran)
intervention type: Drug
intervention name: placebo
description: sterile distilled water (Samen Pharmaceutical Co, Iran)
arm group label: lidocaine & placebo
other name: sterile distilled water (Samen Pharmaceutical Co, Iran)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Masoud Saatchi, DDS MSc
role: Study Chair
affiliation: Isfahan University of Medical Sciences
responsible party type: Sponsor-Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Masoud Saatchi
investigator title: associate professor
mesh term: Pulpitis
mesh term: Lidocaine
mesh term: Epinephrine
sharing ipd: No