<?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>IRCT20230926059527N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-01</date_registration>
      <primary_sponsor>AFID</primary_sponsor>
      <public_title>Effects of Kinesio Taping after Third Mandibular Molar Surgical Extraction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Post Operative Complications with and without Use of Kinesio Tape in Patients Undergoing Surgical Removal Of Impacted Mandibular Third Molars</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>154</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72807</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was performed by using lottery method(Patients with even number chits were placed in one group and with odd number chits in the second group).Allocation concealment was done using folded chits. Patients in first group got Kinesio Taping in addition to usual post op care after third molar extraction and patients in second group got normal post Op Care after mandibular third molar extraction.</study_design>
      <phase>3</phase>
      <hc_freetext>Impacted Mandibular 3rd Molar.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Kinesio Taping in addition to usual care will be performed in this group after surgical removal of the mandibular third molar. Tape will be left in place for 5 days and Post Operative swelling and trismus will be observed on 3th and 5th day. Intervention 2: Control group: Usual Care Group. Only usual care will be performed after surgical extraction of mandibular third molar. Post Operative swelling and trismus will be observed on 3th and 5th day.</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>Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi Near Lalkurti</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi Near Lalkurti</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having physical status 1 according to ASA classification
Surgical extraction performed in mandibular third molars.
Teeth which score =/&gt;5 on Petersons difficulty index for removal of impacted third molars</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients having beard or any other hindrance in application of K- TAPE
Pregnant women, nursing mothers, smokers
Patient with odontogenic infection
Patient with medications that can alter pain perception
Non surgical extraction.
Extraction performed in upper arch or anterior mandibular region.
Teeth with 0.5 mm or more mobility in any direction.
Teeth which score &lt;5 on Pedersons difficulty index for removal of impacted third molars</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impacted teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Kinesio Taping in addition to usual care will be performed in this group after surgical removal of the mandibular third molar. Tape will be left in place for 5 days and Post Operative swelling and trismus will be observed on 3th and 5th day</i_keyword>
      <i_keyword>Control group: Usual Care Group. Only usual care will be performed after surgical extraction of mandibular third molar. Post Operative swelling and trismus will be observed on 3th and 5th day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post Op Swelling &amp;Trismus. Timepoint: 3th and 5th Day after intervention. Method of measurement: Post op swelling will be recorded in millimeters, from specific points already demarcated in the facial region and Trismus will be measured in millimeters.</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>AFID</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-02</approval_date>
        <contact_name>Ethical Committee of AFID</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>
