<?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>IRCT20230714058773N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-03</date_registration>
      <primary_sponsor>Armed forces institute of dentistry CMH Rawalpindi</primary_sponsor>
      <public_title>Comparison of standard incision and comma shaped incision for impacted mandibular third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of standard incision and comma shaped incision for impacted mandibular third molar surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71295</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-probability, Consecutive sampling was done in startified randomization by allotment of random numbers.Randomization was done by giving Odd numbers to the intervention group and even numbers to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Third molar impacted and embedded teeth. Condition 2: Third molar embedded teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A total of 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using comma shaped incisions. Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion. Intervention 2: Control group: 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using standard ward flap incision Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion.</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>Armed forces institute of dentistry CMH 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 CMH Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Range road 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 CMH Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with fully impacted lower third molars (more than two-thirds of the crown covered with alveolar bone evaluated on periapical radiograph or OPG)
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, mandibular angle fractures, tumors
Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01</hc_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Embedded and impacted teeth</hc_keyword>
      <hc_keyword>Impacted teeth</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: A total of 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using comma shaped incisions. Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion.</i_keyword>
      <i_keyword>Control group: 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using standard ward flap incision Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 0 and 1st post operative day. 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>
      <prim_outcome>Post Operative swelling. Timepoint: 1st and 3rd post operative day. Method of measurement: Swelling assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion. These readings were taken pre-operatively and compared with the readings taken on 1st and 3rd day post-operatively.</prim_outcome>
      <prim_outcome>Trismus/ mouth opening. Timepoint: 0 and 1st post operative day. Method of measurement: Mouth opening measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Armed forces institute of dentistry CMH Rawalpindi</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_name>Armed forces institute of dentistry CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-03</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>
