<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210119050080N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of success of inferior alveolar nerve block with and without digital panoramic radiography</public_title>
      <acronym>IANB</acronym>
      <scientific_title>Comparison of success of inferior alveolar nerve block with and without digital panoramic radiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is stratified  based on jaw side. Using random numbers table, it is determined which side of each patient's jaw (right or left) to inject first. Then, in order to prevent bias, injection is performed without using the digital panoramic radiography guide on the side specified by random numbers table. And on the opposite side, injection is performed using a digital panoramic radiography guide, Blinding description: Participants in this study will be blinded to which side of the jaw receives the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Success of inferior alveolar nerve block.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Determination of upper anterior position of mandibular foramen on digital panoramic radiography And calculate the distance to the occlusal plan using a caliper. specify the same distance inside the patient's mouth and perform the injection. Intervention 2: Control group: Confluence Location of horizontal line passes from deepest point of pterygomandibular raphe to vertical line passes from tree quarters of anterior of ramus Determines where the needle enters the inner surface of Ramus. Slowly insert the needle into the tissue to reach the bone stop. The average depth of needle entry is 20 to 25 millimeter .After dealing with the bone, pull out the needle by 1 millimeter and After aspiration, inject 1.5 milliliter of anesthetic solution in 60 seconds.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
A part of the information, such as information on the main outcome, can be shared.

When:
The start of the access period will be 6 to 12 months after the results are released

To whom:
Data will only be available to researchers working in academic institutions.

Conditions:
Data will be available for dental research centers, universities and public private health centers. All clinicians using inferior alveolar nerve block in order to dental procedure are allowed to use the docummentation.

Where to obtain:
Applicants can contact the person responsible for the article to receive the information.
Dr Eshagh Lasemi, elasemi@yahoo.com 00989123871430
No9, Neistan9 Ave, Pasdaran Ave, Tehran

How to obtain:
Demand by email to the person responsible for the article 
elasemi@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Eshagh Lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Neiestan 9 Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>elasemi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Eshagh Lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Neiestan9 Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>sa1373724@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years
Indication of bilateral mandibular block
The power to understand and express the sense
To have digital panoramic radiography
Presence of at least two posterior teeth on each side of mandible</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Contraindications to the use of routine carpol containing epinephrine
Use other anesthesia methods along with the mandibular block
Restriction of mouth opening and trismus
To have not digital panoramic radiography
Having an infection at the injection site
Patient's dissatisfaction to enter the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Determination of upper anterior position of mandibular foramen on digital panoramic radiography And calculate the distance to the occlusal plan using a caliper. specify the same distance inside the patient's mouth and perform the injection</i_keyword>
      <i_keyword>Control group: Confluence Location of horizontal line passes from deepest point of pterygomandibular raphe to vertical line passes from tree quarters of anterior of ramus Determines where the needle enters the inner surface of Ramus. Slowly insert the needle into the tissue to reach the bone stop. The average depth of needle entry is 20 to 25 millimeter .After dealing with the bone, pull out the needle by 1 millimeter and After aspiration, inject 1.5 milliliter of anesthetic solution in 60 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tingling of lower lip and chin. Timepoint: Immediately after injection. Method of measurement: Ask the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Onset of anesthesia. Timepoint: Immediately after injection. Method of measurement: chornometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-14</approval_date>
        <contact_name>Ethics Committee of Dental School, Islamic Azad University of medical science of Tehran</contact_name>
        <contact_address>No.9, Neiestan9 Ave, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
