<?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>IRCT20220707055408N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-22</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>effect of laser 810 nm in orthognathic surgery side effects</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of 810 nm diode laser and pharyngeal pack on reducing oropharyngeal pain, cough and vomiting in patients after bimaxillary orthognathic surgery in patients receiving laser and patients without pharyngeal pack compared to patients with pharyngeal pack and without receiving laser: a randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Online randomization
The numbers of the patients present in the study were entered on the Randomization.com website and were randomly and non-repeatedly divided into two intervention and control groups, Blinding description: In this study, the patients participating in the study were unaware of the assignment of the study group to them despite the prior knowledge of participating in the research. Also, the researcher and data analyst who examines the results and data obtained from each patient are also blinded to the assignment of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oropharyngeal pain after Bimaxillary orthognathic surgery.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: The group receiving 810 nm diode laser radiation in the oropharynx areas, the radiation is done immediately after the operation, the radiation time in each area is 20 seconds and power density will be 0.2 watt per cubic centimeter. Intervention 2: Second Intervention group: the group with pharyngeal pack during surgery. Intervention 3: Control group: The group without pharyngeal pack during surgery and not receiving laser radiation after surgery.</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:
In the intervention group, a 810 nm diode laser is applied to the oropharynx after simultaneous surgery, and the pain in the oropharynx, vomiting and cough is measured after the operation

When:
After publishing the results of research

To whom:
Doctors, Residents, Students

Conditions:
Development of science and research

Where to obtain:
Department of Oral and Maxillofacial Surgery, Hamadan Faculty of Dentistry

How to obtain:
1- Communicating with the general respondent of the research through email address
2- Refer to the oral and maxillofacial surgery department of the Faculty of Dentistry located in Hamadan University of Medical Sciences
3- Introduce yourself and receive the research documents from the person in charge of the information archive

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Hosein Biglarkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 493, Haghgouyan St., Mahdiyeh St.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517719743</zip>
        <telephone>+98 81 3837 2242</telephone>
        <email>mhbiglarkhani@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Jamalpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fahmideh St. Hamedan university of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>jamalpour1972@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 17 and 40 years old are candidates for bimaxillary orthognathic surgery</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have a history of pain in the mouth and face before surgery
Patients who have been treated with analgesics, sedatives or corticosteroids before the operation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R07.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in throat</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group: The group receiving 810 nm diode laser radiation in the oropharynx areas, the radiation is done immediately after the operation, the radiation time in each area is 20 seconds and power density will be 0.2 watt per cubic centimeter</i_keyword>
      <i_keyword>Second Intervention group: the group with pharyngeal pack during surgery</i_keyword>
      <i_keyword>Control group: The group without pharyngeal pack during surgery and not receiving laser radiation after surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The pain score of study subjects in throat and jaw areas. Timepoint: The second, fourth, twelfth, twenty-fourth and forty-eighth hours after the operation. Method of measurement: Pain questionnaire based on Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The degree of nausea and vomiting. Timepoint: The second, fourth, twelfth, twenty-fourth and forty-eighth hours after the operation. Method of measurement: Short questionnaire with 5 questions.</sec_outcome>
      <sec_outcome>The number of coughs after the operation. Timepoint: The second, fourth, twelfth, twenty-fourth and forty-eighth hours after the operation. Method of measurement: Short questionnaire with 5 questions.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-21</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Fahmideh St., Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
