<?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>IRCT20230225057537N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-04</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of effect of articaine with 1:200000 epinepherine on blood glucose in diabetic and non-diabetic patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of articaine with 1:200000 epinepherine on blood glucose in type 2 diabetic and non-diabetic patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68830</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Effect of articaine with 1:200000 epinephrine on blood glucose in diabetic and non-diabetic patients..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Changes of blood glucose after injection of articaine with 1:200000 epinephrine in type 2 diabetic patients. At first, in group of diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer(before injection).  Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method.  For this purpose, the needle will be inserted from the depth of the vestibule and the injection will be performed in the apex area of ​​the desired tooth root.  Blood glucose levels will be measured 5 and 15 minutes after injection. Intervention 2: Intervention group: Changes of blood glucose after articaine 1:100000 epinephrine in healthy(non-diabetic) patients.At first in group of non-diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer. Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method. For this purpose, the needle wil be inserted from the depth of the vestibule and the injection will be performed in the apex area of ​​the desired tooth root.  Blood sugar levels will be measured 5 and 15 minutes after injection.</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:
Part of the data such as information of main outcome can be shared

When:
Access period starts 6 month after the results are published.

To whom:
Documents will be available only to researchers working in academic and scientific institusions.

Conditions:
The use of data to carry out new research projects is permitted.

Where to obtain:
To the email address of the respondent; Amirhosein Akbari :
amirha8991@gmail.com

How to obtain:
After reviewing the incoming emails, the data will be send to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>office unit 610. 6th floor. shriar3 building . farhang str. sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>.</zip>
        <telephone>+98 11 3330 5443</telephone>
        <email>m.taghian@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Taghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>office unit 610. 6th floor. shriar3 building . farhang str. sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>.</zip>
        <telephone>+98 11 3330 5443</telephone>
        <email>m.taghian@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who, according to their own report, either do not have any underlying disease or only have type 2 diabetes.
Patients who need infiltration anesthesia.
Patients with written consent.
Patients who their diabetes is controlled. (minimum 70 mg/dl and maximum 180 mg/dl)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are suffering from any other underlying disease exept type 2 diabetes.
Patients who don't need infiltration anesthesia.
Patients without written consent.
Patients who their diabetes is not controlled.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal glucose tolerance test</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: Changes of blood glucose after injection of articaine with 1:200000 epinephrine in type 2 diabetic patients. At first, in group of diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer(before injection).  Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method.  For this purpose, the needle will be inserted from the depth of the vestibule and the injection will be performed in the apex area of ​​the desired tooth root.  Blood glucose levels will be measured 5 and 15 minutes after injection.</i_keyword>
      <i_keyword>Intervention group: Changes of blood glucose after articaine 1:100000 epinephrine in healthy(non-diabetic) patients.At first in group of non-diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer. Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method. For this purpose, the needle wil be inserted from the depth of the vestibule and the injection will be performed in the apex area of ​​the desired tooth root.  Blood sugar levels will be measured 5 and 15 minutes after injection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of blood glucose. Timepoint: 1.Before injection. 2.After. 5minutes of injection 3. After15minutes of injection. Method of measurement: Blood glucose monitoring system (glucometer).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-16</approval_date>
        <contact_name>Ethics committee of mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran university of medical sciences. Farahabad blvd. Sari. Iran sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
