<?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>IRCT20200516047458N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-17</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dental occlusion on posture of the body</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effectiveness of dental occlusion on postural position of body in students of semester 8 to semester 12 at Shahid Beheshti School of dentistry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Randomization method: block randomization
Randomization unit: individual
Used the website https://www.Randomization.com
40 subjects randomized into 5 blocks.
in order to reproduce this plan, used the seed 9580 . the number of subjects per block were 8 , number of blocks were 5 and treatment labels were case and control  as entered originally.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Occlusal problems.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Those who have received occlusal splint treatment. Occlusal splint is a prosthetic appliance that is made using transparent acrylic (made in Acropars Factory, Iran) in the laboratory. This device  directs the mandible to the centric jaw position.All samples in this group use this occlusal splint for one month. Intervention 2: Control group: Those who have not received any treatment. The members of this group only participate in the balance study sessions  with the other group.</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>Seyed Majid Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti university of medical sciences,School of Rehabilitation Sciences,  Damavand St, Across from Bu Ali Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>majidhosseini44@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Majid Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti university of medical sciences,School of Rehabilitation Sciences,  Damavand St, Across from Bu Ali Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>majidhosseini44@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-compliance of the central relationship with the maximum intercuspation
Ability to walk at least 10 meters independently without the use of auxiliary devices
Ability to stand independently on the highest level of stability of the Biodox device</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of neurological disease, systemic disease, equilibrium or labyrinthine disease
Having acute or major orthopedic problems, especially in the pelvis, lower limbs and spine
Existence of acute uncorrected vision problems
The presence of sensory disturbances or vascular pathology in the lower extremities
Have a history of falling in the last year
History of heart attack in the last 6 months
History of fractures of the lower limbs in the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of temporomandibular joint</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Those who have received occlusal splint treatment. Occlusal splint is a prosthetic appliance that is made using transparent acrylic (made in Acropars Factory, Iran) in the laboratory. This device  directs the mandible to the centric jaw position.All samples in this group use this occlusal splint for one month.</i_keyword>
      <i_keyword>Control group: Those who have not received any treatment. The members of this group only participate in the balance study sessions  with the other group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medial-lateral stability index (MLSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the medial-lateral axis. Naturally, the lower the number of index indicates the better the stability and  lower postural deviation. Timepoint: 1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session. Method of measurement: The variable was collected by the Biodex system as a result of the sample performances.</prim_outcome>
      <prim_outcome>Anterior-posterior stability index (APSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the anterior-posterior axis. Naturally, the lower the number of index indicates the better the stability and  lower postural deviation. Timepoint: 1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session. Method of measurement: The variable was collected by the Biodex system as a result of the sample performances.</prim_outcome>
      <prim_outcome>Overall stability index (OSI)This number, calculated by the device, is the oscillation of the center of gravity of the body relative to the zero point on the overall axis. Naturally, the lower the number of index indicates the better the stability and  lower postural deviation. Timepoint: 1. Before the intervention of the first session 2. After the intervention of the first session 3.One month after the first session. Method of measurement: The variable was collected by the Biodex system as a result of the sample performances.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-18</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti Research Institute for Dental Sciences</contact_name>
        <contact_address>5th Floor, Shahid Beheshti,Dental School, Evin, Tehran-IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
