<?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>IRCT20181122041724N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of auricular acupuncture on  nerve block injection</public_title>
      <acronym></acronym>
      <scientific_title>The effect of auricular acupuncture on the success of inferior alveolar nerve block among patients with irreversible pulpitis in mandibular teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35699</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the patients, 56 papers will be numbered 1 to 56, and the first 28 papers will be placed individually in a red sealed envelope; the remaining 28 will be placed individually in a blue sealed envelope. Each female participant will be instructed to select a red sealed envelope, and each male participant will be asked to select blue one. 
Upon opening the envelopes, based on the number (odd numbers for the auricular acupuncture group and even numbers for the control
group), they will be assigned to 1 of the 2 corresponding groups. This ensures an equal number of male and female participants per group, Blinding description: Clinical observer:
An instructed person will apply acupuncture, and a second investigator who is an endodontist administers IANB injection and endodontic procedure will be done. No one knows patients belong to which group , except who applies acupuncture so others are blind. 

Patient:
In the acupuncture experimental group, the acupuncture points will be selected by acupuncture probe. An ASP acupuncture needle will be inserted at mentioned points on the side of the subjected tooth and sticking plaster will be used on that. In control group same points will be find by acupuncture probe but acupuncture needle will be inserted at other points which have no effect on dental pain and sticking plaster will be used on those points . At the end of the endodontics procedure , the acupuncture’s ASPs and sticking plasters will be removed so patients will not understand the difference and they are blind.

The person who evaluates the result:
The same person who accomplish endodontic procedure will ask about patient's pain during procedure(who is blind) and at last gives the result to the person who applies acupuncture (who is not blind) .

Data analyzer:
The person who analyzes  data , will not know patients belong to which group and therefore he will be blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mandibular molar with irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the acupuncture experimental group, the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe. An ASP acupuncture needle will be inserted at mentioned points on the side of the subjected tooth and sticking plaster will be used on that. Intervention 2: Control group: In the Control group  the same procedure will be mimiced . the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe but a real puncture of needle will not happen at mentioned points and only sticking plaster will be used on those points.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Esnaashari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No 121, Boostan 9 Street, Pasdaran Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2279 3163</telephone>
        <email>E_esnaashari@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Esnaashari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No 121, Boostan 9 Street, Pasdaran Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2279 3163</telephone>
        <email>E_esnaashari@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have a mandibular molar with irreversible pulpitis . These teeth will be evaluated via an electric pulp test and a cold test
Patients Between 18 and 65 years old
Patients who agree to participate in this study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Systemic and mental disease
Using alcohol, any drug and smoking
taking any analgesic drugs in last 6 hours
using any type of antidepressant medication such as TCA  and SSRIs that could affect the perception of pain
using any type of corticosteroid
sensitivity to lidocaine
patient’s age under 18 and over 65
periapical radiolucency or even a widening of the periodontal ligament space in radiography
patients who do not report lip numbness during15 minute after injection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the acupuncture experimental group, the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe. An ASP acupuncture needle will be inserted at mentioned points on the side of the subjected tooth and sticking plaster will be used on that.</i_keyword>
      <i_keyword>Control group: In the Control group  the same procedure will be mimiced . the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe but a real puncture of needle will not happen at mentioned points and only sticking plaster will be used on those points.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of pain reported by patient on 100 mm type of visual analog scale. Timepoint: during cavity preparation of dentin, exposure of pulp chamber and inserting initial file. Method of measurement: 100 mm type of visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2018-04-22</approval_date>
        <contact_name>Ethics committee of Central organizationn of Islamic Azad  University</contact_name>
        <contact_address>No 9, Neyestan 9 ,Pasdaran Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
