<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/NCT03786211</url>
  </required_header>
  <id_info>
    <org_study_id>HMS 50126</org_study_id>
    <nct_id>NCT03786211</nct_id>
  </id_info>
  <brief_title>IANB Success Rate With and Without Panoramic Help</brief_title>
  <official_title>The Success of the Inferior Alveolar Nerve Block Anesthesia With Alveolar Nerve Localization by Using of Panoramic Radiography in Comparison to Routine IAN Block Anesthesia: RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hormozgan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hormozgan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low&#xD;
      and there are a lot of anatomic variations for the location of inferior alveolar nerve in&#xD;
      different races, investigators decided to compare the success rate of inferior alveolar nerve&#xD;
      block, with and without using a panoramic radiograph in Bandar Abbas population, and see if&#xD;
      using a panoramic radiograph can increase the preciseness of the injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded cross-over randomized controlled trial study conducted on all the&#xD;
      patients of the dental clinic indicated for bilateral extraction or filling.&#xD;
&#xD;
      The randomization method is block balanced randomization. All patients will ask to fulfill&#xD;
      the ethical Form. This form acquired demographic information (e.g. age, sex) about patients.&#xD;
      A panoramic radiograph will take from those who matched the inclusion criteria and signed the&#xD;
      agreement. Then a tooth from one side will be treated and the tooth from the other side of&#xD;
      the mouth will treat at least 2 weeks later by the same dentist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with good Anesthesia</measure>
    <time_frame>30 minutes after injection</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anesthesia</condition>
  <condition>Anesthesia; Functional</condition>
  <arm_group>
    <arm_group_label>IANB without panoramic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will get Ianb without using panoramic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IANB with panoramic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>They will get IANB by the guide of panoramic</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IANB by the guide of Panoramic</intervention_name>
    <description>IANB will be injected by the guide of panoramic radiograph</description>
    <arm_group_label>IANB with panoramic</arm_group_label>
    <arm_group_label>IANB without panoramic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IANB without the guide of Panoramic</intervention_name>
    <description>IANB will be injected without the guide of panoramic radiograph, in the routine way.</description>
    <arm_group_label>IANB with panoramic</arm_group_label>
    <arm_group_label>IANB without panoramic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients indicated for bilateral tooth extractions of fillings.&#xD;
&#xD;
          -  Physically and mentally healthy patients who could express their pain.&#xD;
&#xD;
          -  having panoramic radiograph from the past six months for other dental purposes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sensitive to the regular anesthetics containing epinephrine.&#xD;
&#xD;
          -  patients with acute or chronic pericoronitis.&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  trismus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hossein Dabbagh, Md, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sajad Ansarifard, DDS, PhD</last_name>
    <phone>?989366584476</phone>
    <email>Sajad.ansarifard@hums.ac.ir</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hossein Dabbagh</last_name>
    <email>hossein.dabagh@hums.ac.ir</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dental clinic of BandarAbbas faculty of dentistry</name>
      <address>
        <city>BandarAbbas</city>
        <state>Hormozgan</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hossein Dabbagh, Md, PhD</last_name>
      <email>hossein.dabagh@hums.ac.ir</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hormozgan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Sajad Ansari Fard</investigator_full_name>
    <investigator_title>PhD, Student research committee</investigator_title>
  </responsible_party>
  <keyword>Mandible</keyword>
  <keyword>Anesthesia</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03786211
org study id: HMS 50126
nct id: NCT03786211
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low
      and there are a lot of anatomic variations for the location of inferior alveolar nerve in
      different races, investigators decided to compare the success rate of inferior alveolar nerve
      block, with and without using a panoramic radiograph in Bandar Abbas population, and see if
      using a panoramic radiograph can increase the preciseness of the injection.
This is a double blinded cross-over randomized controlled trial study conducted on all the
      patients of the dental clinic indicated for bilateral extraction or filling.

      The randomization method is block balanced randomization. All patients will ask to fulfill
      the ethical Form. This form acquired demographic information (e.g. age, sex) about patients.
      A panoramic radiograph will take from those who matched the inclusion criteria and signed the
      agreement. Then a tooth from one side will be treated and the tooth from the other side of
      the mouth will treat at least 2 weeks later by the same dentist.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants with good Anesthesia
time frame: 30 minutes after injection
arm group label: IANB without panoramic
arm group type: Active Comparator
description: They will get Ianb without using panoramic
arm group label: IANB with panoramic
arm group type: Experimental
description: They will get IANB by the guide of panoramic
intervention type: Procedure
intervention name: IANB by the guide of Panoramic
description: IANB will be injected by the guide of panoramic radiograph
arm group label: IANB with panoramic
arm group label: IANB without panoramic
intervention type: Procedure
intervention name: IANB without the guide of Panoramic
description: IANB will be injected without the guide of panoramic radiograph, in the routine way.
arm group label: IANB with panoramic
arm group label: IANB without panoramic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hossein Dabbagh, Md, PhD
role: Study Chair
affiliation: Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
last name: Sajad Ansarifard, DDS, PhD
phone: ?989366584476
email: Sajad.ansarifard@hums.ac.ir
last name: Hossein Dabbagh
email: hossein.dabagh@hums.ac.ir
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Hormozgan University of Medical Sciences
investigator full name: Sajad Ansari Fard
investigator title: PhD, Student research committee
sharing ipd: Yes