<?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>IRCT20230622058557N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-04</date_registration>
      <primary_sponsor>Armed Forces Institute of Dentistry</primary_sponsor>
      <public_title>Effect of buffered anesthetics in odontogenic infections</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of buffered with standard local anesthetics in odontogenic infections: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70907</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed using a sealed envelope with a computer-generated random allocation for each patient. According to the this, patients were randomly divided to receive either be in the Buffered Group (A) or Non Buffered Group (B), Blinding description: Double-blind fashion technique was used in which the patient is unaware of the type of anesthetic being administered to them , buffered or standard and the Doctor administering the local anesthesia doesn't know if the cartridge has been buffered or not. It was prepared by another researcher and handed to the doctor administering the injection.</study_design>
      <phase>4</phase>
      <hc_freetext>Condition 1: Odontogenic Infection: Defined as inflammation originating within a tooth or closely related to the surrounding structures presenting as periapical inflammation in the form of acute periapical periodontitis or a periapical abscess with or without extensions into adjacent facial planes. Condition 2: Odontogenic Infection: Defined as inflammation originating within a tooth or closely related to the surrounding structures presenting as periapical inflammation in the form of acute periapical periodontitis or a periapical abscess with or without extensions into adjacent facial planes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A. This group received buffered local anesthesia by adding 0.18 ml of  8.4 percent sodium bicarbonate solution to 1.8ml 2 % Lignocaine with 1:100,000 adrenaline cartridge immediately before injecting. Intervention 2: Intervention group: Group B. This group will receive standard 2 % Lignocaine with 1:100,000 adrenaline cartridge that has not been buffered.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is It is the organization's policy to not share IPD</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Syeda Mahnoor Fatima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID,CMH, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 335 5508126</telephone>
        <email>mahnooorbukhari@gmai.com</email>
        <affiliation>Armed Forces Institute of Dentistry affiliated with National University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54810</zip>
        <telephone>+92 343 9853049</telephone>
        <email>zahra.saeed15@gmail.com</email>
        <affiliation>Combined Military Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient between 18 to 70 years that have Odontogenic maxillofacial infection surrounding any tooth.
Lack of sensitivity to local anesthetics
Patients having acute abscess of any tooth
Patients having acute periapical periodontitis leading to granuloma formation
Patients having physical status 1 and 2 according to American Society of Anesthesiologists(ASA) classification</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic diseases for which injections of lignocaine with adrenaline are contraindicated will be excluded from the study
Anesthesia allergy or drug abuse history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.7</hc_code>
      <hc_code>K04.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Periapical abscess without sinus</hc_keyword>
      <hc_keyword>Acute apical periodontitis of pulpal origin</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: Group A. This group received buffered local anesthesia by adding 0.18 ml of  8.4 percent sodium bicarbonate solution to 1.8ml 2 % Lignocaine with 1:100,000 adrenaline cartridge immediately before injecting.</i_keyword>
      <i_keyword>Intervention group: Group B. This group will receive standard 2 % Lignocaine with 1:100,000 adrenaline cartridge that has not been buffered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Assessment: Pain will be determined by the patient before and after injection using VAS Pain score. It is a 10 cm long scale with 0 marking indicating no pain to 10 marking as worst pain possible. Timepoint: Before and immediately after local anesthetic injection. Method of measurement: Visual Analog Pain Score.</prim_outcome>
      <prim_outcome>Efficacy of Anesthesia: Determined by the onset of anesthesia i.e. the first feeling of numbness in the region of the teeth anaesthetized checked by inserting straight probe in the gingival sulcus of the involved region. Timepoint: Immediately after injection is administered with 30 seconds intervals . Method of measurement: Seconds.</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>Armed Forces Institute of Dentistry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-09</approval_date>
        <contact_name>Ethics Committee- Armed Forces Institute of Dentistry</contact_name>
        <contact_address>AFID, CMH, Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
