<?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>IRCT20230926059527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-28</date_registration>
      <primary_sponsor>AFID</primary_sponsor>
      <public_title>Mental Nerve Neurectomy: A Comparison Of Titanium Screw VS Gutta Percha Obturation of Mental Foramen</public_title>
      <acronym></acronym>
      <scientific_title>Mental Nerve Neurectomy: A Comparison Of Titanium Screw Versus Gutta Percha Obturation of Mental Foramen</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72778</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients assigned serial numbers as they got treatment. Evens in Titanium Screen Group and Odds in Gutta Percha Stick Group, Blinding description: Patients were blinded as they were not informed about the treatment modality used for management of their ailment.</study_design>
      <phase>3</phase>
      <hc_freetext>Trigeminal Neuralgia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Titanium Screw Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Titanium Screw will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and remission of pain will be assessed after three months. Intervention 2: Intervention group: Gutta Percha Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Gutta Percha Sticks will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and Remession of pain will be assessed after three months.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no Further Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Syed Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>AFID</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Syed Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi</address>
        <city>Rawalpind</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>AFID</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral Pain with Typical Signs of Trigeminal Neuralgia
Past Medical History of Carbamezapine intake
No Odontogenic Cause of Pain
No Organic Cause of Pain</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Atypical Facial Pain/Pain of Unknown Cause
Bilateral Pain/ Uncommon Distribution of Pain
Longer than Normal Neuralgic Pain
Pain of Odontogenic Cause
Pain having Organic Origin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trigeminal neuralgia</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: Titanium Screw Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Titanium Screw will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and remission of pain will be assessed after three months</i_keyword>
      <i_keyword>Intervention group: Gutta Percha Group, After obtaining Informed Consent regarding the procedure and needs of it ,Peripheral neurectomy followed by Mental Foramen obturation using Gutta Percha Sticks will be performed. Operator's Compliance will be assessed immediately after the procedure. Post Op Displacement and Remession of pain will be assessed after three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>More Operators Compliance, Decreased Post Neurectomy Pain and Decreased Incidence of Displacement of Obturation materail will be observed in Titanium Screw Group. Timepoint: 3 months after Intervention. Method of measurement: Operators ease will be measured using questionnaire. Displacement will be observed on Orthopantomogram and Remission of Pain will be assessed by using VAS.</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>2023-07-19</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>
