<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/NCT04477317</url>
  </required_header>
  <id_info>
    <org_study_id>local anesthesia in chilldren</org_study_id>
    <nct_id>NCT04477317</nct_id>
  </id_info>
  <brief_title>Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children</brief_title>
  <official_title>Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to evaluate and compare the anesthetic efficacy of&#xD;
      Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of&#xD;
      badly decayed or unrestorable maxillary first primary molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To our knowledge, no clinical trials in literature have been done to compare anesthetic&#xD;
      efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly&#xD;
      decayed upper first primary molars. Thus, the purpose of the present study was to fill this&#xD;
      knowledge gap.&#xD;
&#xD;
      This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine&#xD;
      anesthetic solution where no clinical trials have been conducted on it yet in literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-operative pain during extraction</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>onset of anesthesia</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>measured in minutes using stopwatch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of anesthesia</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>measured in minutes using stopwatch</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Local Anesthesia</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4% Articaine Hydrochloride with 1:100,000 Adrenaline</intervention_name>
    <description>new Egyptian articane anesthetic solution.</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>%4 Alexadricaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin</intervention_name>
    <description>Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>2% Mepicaine-L</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically fit (ASA I, II).&#xD;
&#xD;
          -  Mentally capable of communication.&#xD;
&#xD;
          -  Children aged 5-7 years, children older than 8 years old will not be included due to&#xD;
             physiologic root resorption associated with shedding which may simplify the extraction&#xD;
             procedure(25).&#xD;
&#xD;
          -  First maxillary primary molar needs extraction due to root caries &quot;beyond possible&#xD;
             repair&quot;.&#xD;
&#xD;
          -  First dental visit.&#xD;
&#xD;
          -  Child must give assent prior to participation, as well as approved parental informed&#xD;
             written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with acute or sub-acute dento-alveolar abscess Children with history of&#xD;
             prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.&#xD;
&#xD;
          -  Patients who had taken analgesics or antibiotics in the 12-hrs preceding the&#xD;
             injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara A mahmoud, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of dentistry cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 11, 2023</last_update_submitted>
  <last_update_submitted_qc>March 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ghada Mohamed Mostafa Mahmoud</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Nordefrin</mesh_term>
    <mesh_term>Carticaine</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04477317
org study id: local anesthesia in chilldren
nct id: NCT04477317
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the present study is to evaluate and compare the anesthetic efficacy of
      Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of
      badly decayed or unrestorable maxillary first primary molars.
To our knowledge, no clinical trials in literature have been done to compare anesthetic
      efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly
      decayed upper first primary molars. Thus, the purpose of the present study was to fill this
      knowledge gap.

      This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine
      anesthetic solution where no clinical trials have been conducted on it yet in literature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Intra-operative pain during extraction
time frame: through study completion, an average of 1 year
description: measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale
measure: onset of anesthesia
time frame: through study completion, an average of 1 year
description: measured in minutes using stopwatch
measure: duration of anesthesia
time frame: through study completion, an average of 1 year
description: measured in minutes using stopwatch
arm group label: Experimental
arm group type: Experimental
description: 4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt).
arm group label: Control
arm group type: Active Comparator
description: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt)
intervention type: Drug
intervention name: 4% Articaine Hydrochloride with 1:100,000 Adrenaline
description: new Egyptian articane anesthetic solution.
arm group label: Experimental
other name: %4 Alexadricaine
intervention type: Drug
intervention name: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin
description: Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.
arm group label: Control
other name: 2% Mepicaine-L
criteria: 
gender: All
minimum age: 5 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara A mahmoud, Assoc. Prof.
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ghada Mohamed Mostafa Mahmoud
investigator title: Dr
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Nordefrin
mesh term: Carticaine
mesh term: Mepivacaine
mesh term: Epinephryl borate