<?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>IRCT20211230053569N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-11</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Anesthetic efficacy of articaine with lidocaine in symptomatic irreversible pulpitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of anesthetic efficacy of articaine with lidocaine as an inferior nerve blocking agent in subjects with symptomatic irreversible pulpitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61076</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before the experiment, each of the two anesthetic solutions will be labeled as A and B. Simple, individual randomization will be done and subjects will be randomly allocated either solution A or B, using online randomization software (OpenEpi), Blinding description: Before the experiment, each of the two anesthetic solutions will be covered to conceal the name of the product and labeled as A and B respectively. Both the chief researcher and the patient will be unaware of which alphabet represents which solution.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Symptomatic irreversible pulpitis in posterior mandibular teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels) receiving 1.7 ml of 4% articaine with 1:100,000 epinephrine (Septanest SP) as inferior nerve blocking agent. Intervention 2: Control group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels)  receiving 1.7 ml of 2% lidocaine with 1:100,000 epinephrine (Lignospan standard), as inferior nerve blocking agent.</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 Subject to willingness of the participants of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sobia Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street 41A, 7th Avenue, G-7/4</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 2891835</telephone>
        <email>sobia.hassan@riphah.edu.pk</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sobia Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street 41A, 7th Avenue, G-7/4</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 2891835</telephone>
        <email>sobia.hassan@riphah.edu.pk</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects of both genders (males and females), in good health, with no systemic disease that will interfere with the action of any of the anesthetic solutions being used, aged between 26 – 35 years
Mandibular posterior teeth requiring endodontic treatment due to symptomatic irreversible pulpitis
There should have been no previous attempts of endodontic therapy on that tooth
Positive pulp sensibility testing (cold testing)</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have known allergy to amides
Patients taking any medication that will alter their perception of pain
Patients who are suffering from any heart disease, diabetes mellitus
Female patients who are pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irreversible pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels) receiving 1.7 ml of 4% articaine with 1:100,000 epinephrine (Septanest SP) as inferior nerve blocking agent.</i_keyword>
      <i_keyword>Control group: subjects diagnosed with symptomatic irreversible pulpitis (after taking history, carrying out cold testing and filling the Visual Analogue Scale to score pain levels)  receiving 1.7 ml of 2% lidocaine with 1:100,000 epinephrine (Lignospan standard), as inferior nerve blocking agent.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain relief after anesthesia. Timepoint: Immediately after intervention. Method of measurement: Visual Analogue Scale for pain assessment.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Ethics Committee of Islamic International Dental College</contact_name>
        <contact_address>Street 41, off 7th Avenue, G-7/4 Islamabad ICT Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
