<?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>IRCT20230714058773N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-11</date_registration>
      <primary_sponsor>Armed forces institute of dentistry CMH Rawalpindi</primary_sponsor>
      <public_title>Comparison between the Use of Only Buccal Infiltration and with palatal infiltration Of 2% Lidocaine with Epinephrine for The Removal of Maxillary Teeth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the Use of Only Buccal Infiltration and with palatal infiltration Of 2% Lidocaine with Epinephrine for The Removal of Maxillary Teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>260</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Buccal Infiltration, Palatal infiltration, Maxillary Teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  130 patients were selected according to inclusion criteria.  Before administration of the local anaesthetic agent, each patient was instructed on the Visual Analog Scale (VAS) by a dental assistant. Patients were receive infiltration of 2 mL (2% lidocaine HCl with 1:100,000 epinephrine) in the mucobuccal fold adjacent to tooth, at a slow rate of administration, over approximately 1 minute under aseptic technique. Then, extraction was performed after the wait of 10 minutes in all the patients . During the latency period, patients were complete the VAS as their own control, to score on the 10 points Visual analog scale, to record the amount of pain they get experience on injection. Immediately after extraction, patients later on was asked again to record the  experienced pain intensity during the extraction on data collection form on 10 points Visual Analog Scale (VAS). Intervention 2: Control group: 130 patients were selected according to inclusion criteria  Before administration of the local anaesthetic agent, each patient was instructed on the Visual Analog Scale (VAS) by a dental assistant.  Patients were receive infiltration of 2 mL (2% lidocaine HCl with 1:100,000 epinephrine in the mucobuccal fold adjacent to tooth and 0.25 mL infiltration palatally at a slow rate of administration, over approximately 1 minute under aseptic technique. Then, extraction was performed after the wait of 10 minutes in all the patients . During the latency period, patients were complete the VAS as their own control, to score on the 10 points Visual analog scale, to record the amount of pain they get experience on injection. For extraction, elevation and forced techniques were used but with minimal reflection of palatal gingiva. Immediately after extraction, patients later on was asked again to record the  experienced pain intensity during the extraction on data collection form on 10 points Visual Analog Scale (VAS).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam@hotmail.com</email>
        <affiliation>Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam@hotmail.com</email>
        <affiliation>Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>non-restorable tooth due to extensive caries or periodontal disease or for orthodontic extractions
Patients between the age of 18 and 45 years
Patients having physical status 1 according to American Society of Anesthesiologists (ASA) classification.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women, nursing mothers
Patient with non-localized odontogenic infection
Tooth associated with pathologies i.e. cysts, fractures, tumors
Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease.</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  130 patients were selected according to inclusion criteria.  Before administration of the local anaesthetic agent, each patient was instructed on the Visual Analog Scale (VAS) by a dental assistant. Patients were receive infiltration of 2 mL (2% lidocaine HCl with 1:100,000 epinephrine) in the mucobuccal fold adjacent to tooth, at a slow rate of administration, over approximately 1 minute under aseptic technique. Then, extraction was performed after the wait of 10 minutes in all the patients . During the latency period, patients were complete the VAS as their own control, to score on the 10 points Visual analog scale, to record the amount of pain they get experience on injection. Immediately after extraction, patients later on was asked again to record the  experienced pain intensity during the extraction on data collection form on 10 points Visual Analog Scale (VAS).</i_keyword>
      <i_keyword>Control group: 130 patients were selected according to inclusion criteria  Before administration of the local anaesthetic agent, each patient was instructed on the Visual Analog Scale (VAS) by a dental assistant.  Patients were receive infiltration of 2 mL (2% lidocaine HCl with 1:100,000 epinephrine in the mucobuccal fold adjacent to tooth and 0.25 mL infiltration palatally at a slow rate of administration, over approximately 1 minute under aseptic technique. Then, extraction was performed after the wait of 10 minutes in all the patients . During the latency period, patients were complete the VAS as their own control, to score on the 10 points Visual analog scale, to record the amount of pain they get experience on injection. For extraction, elevation and forced techniques were used but with minimal reflection of palatal gingiva. Immediately after extraction, patients later on was asked again to record the  experienced pain intensity during the extraction on data collection form on 10 points Visual Analog Scale (VAS).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 10 minutes After infiltration of local anesthesia and immediately after extraction. Method of measurement: 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain . If VAS ≥ 7 then it was considered pain.</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 CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-30</approval_date>
        <contact_name>Ethics committee of armed forces institute of dentistry CMH Rawalpindi</contact_name>
        <contact_address>Range road Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
