<?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>IRCT20230714058773N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-06</date_registration>
      <primary_sponsor>Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi</primary_sponsor>
      <public_title>Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>260</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91995</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Patients meeting the inclusion criteria were randomised into Group A (single buccal infiltration) or Group B (conventional buccal and palatal infiltration) using the lottery method. Equal numbers of folded paper chits marked "A" and "B" were prepared, corresponding to the total planned sample size, and placed in a sealed opaque container. At the time of enrolment, after the patient had provided informed consent, one chit was drawn by a staff member not involved in performing the extraction, and the patient was allocated to the group indicated on the chit. Each chit was discarded after use so that it could not be redrawn, ensuring that every patient had an equal and independent chance of allocation to either group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Need for maxillary tooth extraction (due to non-restorable caries, periodontal disease, or orthodontic indication).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: single buccal infiltration (2 mL, 2% lidocaine HCl with 1:100,000 epinephrine). Intervention 2: Control group: conventional buccal + palatal infiltration (1.75 mL buccal + 0.25 mL palatal, same anesthetic).</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:
Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction

When:
after publication for good

To whom:
everyone

Conditions:
everyone

Where to obtain:
tehminamaryam27@gmail.com

How to obtain:
Researchers interested in accessing the de-identified dataset and/or data collection forms may submit a written request to the corresponding author, along with a brief description of the intended use. Requests will be reviewed and, upon approval from the Department of Oral and Maxillofacial Surgery, AFID Rawalpindi, the relevant data will be shared within few weeks of the request. Data will be provided in pdf file and will exclude any patient-identifying information in line with the informed consent obtained from participants.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam27@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam27@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients presented to Oral and Maxillofacial surgery for any maxillary tooth removal for reasons like non-restorable tooth due to extensive caries or periodontal disease or for orthodontic extractions and assessed as suitable for removal under local anaesthesia.
Patients between the age of 18 and 45 years who were fit for the procedure.
Either gender.
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>maxillary </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>maxillary tooth extraction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: single buccal infiltration (2 mL, 2% lidocaine HCl with 1:100,000 epinephrine)</i_keyword>
      <i_keyword>Control group: conventional buccal + palatal infiltration (1.75 mL buccal + 0.25 mL palatal, same anesthetic)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 10 minutes after injection and immediately after extraction. Method of measurement: visual analog scale.</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. Combined Military Hospital, Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-15</approval_date>
        <contact_name>Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi</contact_name>
        <contact_address>Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi Rawalpindi punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
