<?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>IRCT20140527017880N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-12</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions</public_title>
      <acronym></acronym>
      <scientific_title>The comparative evaluation of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions, Lidocaine and prilocaine in Patients Requiring Restorative Treatment of molar Teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization tools are sealed envelopes. Random unit is of individual type. Randomization is a simple way so that numbness cartridges are covered by covers and for each type of numbness we consider one of the numbers 1 and 2 and write the considered number on the cartridges covered with the covers (Each number represents a particular type of anesthetic substance). Then the patient chooses one of these cartridges.
These cartridges are provided to patients who visit the Dental Clinics of Kermanshah from May 20, 2018 to June 20, 2018 for restoration of the molar teeth.
Placing covers and writing numbers is done only by one of the researchers, so the injector, the evaluator and the participant, are unaware of the type of anesthesia, Blinding description: Both anesthetics used in the study are safe and do not pose a risk to patients. Before doing the study, written consent is taken from the patients.
One of the cartridges covered with a cover that one of the numbers 1 and 2 is written on it, Is selected by the patient (Each number represents a particular type of anesthetic substance).
Placing covers and writing numbers is done only by one of the researchers, so the injector, the evaluator and the participant, are unaware of the type of anesthesia.</study_design>
      <phase>3</phase>
      <hc_freetext>Local anaesthetics.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Block injection in mandible with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran). Intervention 2: Intervention group: infiltration injection in maxilla with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran). Intervention 3: Intervention group: Block injection in mandible with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran). Intervention 4: Intervention group: infiltration injection in maxilla with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran).</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:
The comparative evaluation of maxillary infiltration and mandibular block injection effect on the cardiovascular parameters with 2 different local anesthesia solutions, Lidocaine and prilocaine in Patients Requiring Restorative Treatment of molar Teeth

When:
The start of the access period is 6 months after the results are printed

To whom:
Study data will be available to researchers working in academic and scientific institutions

Conditions:
Access to study data is allowed

Where to obtain:
Dr Roohollah Sharifi, Faculty Member of Kermanshah University of Medical Sciences
 Mobile phone: 09122177490

How to obtain:
The data can be submitted to Dr. Rouhollah Sharifi by sending an email.
r.sharifi@kums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra lami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite of the post office, Shora st, Dr Shariati st, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6713954658</zip>
        <telephone>+98 83 3722 2400</telephone>
        <email>zahra.lami@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Roohollah Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite of the post office, Shora st, Dr Shariati st, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6713954658</zip>
        <telephone>+98 83 3722 7151</telephone>
        <email>roholahsharifi@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 20-50 years
Have general health
needing restorative treatment of maxillary or mandibular molar teeth</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with medical history of cardiovascular, hypertension, Diabetes, kidney diseases, gastrointestinal bleeding or ulceration
Use of medications that make disturbance in function of anesthetic substance
Patients with pathology problems at the injection site
pregnant and nursing patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Local anaesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Block injection in mandible with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran)</i_keyword>
      <i_keyword>Intervention group: infiltration injection in maxilla with 1/8 milliliter of lidocaine 2% solution with epinephrine 1: 80,000 (Darou Pakhsh/iran)</i_keyword>
      <i_keyword>Intervention group: Block injection in mandible with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran)</i_keyword>
      <i_keyword>Intervention group: infiltration injection in maxilla with 1/8 milliliter of prilocaine Hcl 3% solution with felypressin 0.03 IU (Darou Pakhsh/iran)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of systolic blood pressure. Timepoint: 10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection. Method of measurement: automatic brachial pressure gauge device.</prim_outcome>
      <prim_outcome>Level of diastolic blood pressure. Timepoint: 10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection. Method of measurement: automatic brachial pressure gauge device.</prim_outcome>
      <prim_outcome>Heart rate per minute. Timepoint: 10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection. Method of measurement: Finger pulse oximeter.</prim_outcome>
      <prim_outcome>Peripheral blood oxygen saturation percentage. Timepoint: 10 minutes before injection, immediately after injection, 10 minutes after injection, 20 minutes after injection. Method of measurement: Finger pulse oximeter.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-25</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
