<?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>IRCT20090118001559N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care on ear problems in people with jaw problems</public_title>
      <acronym>TMD</acronym>
      <scientific_title>The efficacy of self-care on ear symptoms in patients with temporomandibular joint disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66857</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: otalgia. Condition 2: tinnitus. Condition 3: Temporomandibular joint disorders.</hc_freetext>
      <i_freetext>Intervention group: In patients who have jaw problems and also complain of ear pain, ear fullness or tinnitus, the symptoms of temporomandibular disorders will be examined by a trained examiner and the diagnosis of temporomandibular disorders will be confirmed with the criteria of the RDC-TMD questionnaire and the severity of dysfunction Helkimo's clinical criteria will be registered. Patients are then asked to rate the pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents maximum pain. Tinnitus is evaluated by tinnitus handicap inventory and severity of earache and ear fullness by grading from 0 to 10. After recording symptoms, the necessary "self-care" training will be given in the form of a short seminar, along with skills training provided through demonstrations, exercises between sessions, and structured feedback during sessions and phone calls. Self-care includes: education (about the socio-biology model of TMD, chronic pain, multifaceted aspects of the cause of TMD, management methods, and the logic of self-management), bilateral chewing, limitation of mouth opening (opening the mouth within the range of the patient's pain threshold ), diet control (avoid eating hard food), yawn control (opposite pressure on the back of both hands under the chin), thermal modalities (use of moist heat (twice a day for 20 minutes each time) and ice compresses (1 time and 10 minutes each time) alone or together), massage therapy (touching and caressing the muscles along them), controlling parafunctional behaviors (putting their tongue behind the front teeth of the upper jaw, such as when say "N" and then close your mouth and when the lower jaw was in a resting position, leave a few millimeters of space between the occlusion surfaces of the upper and lower teeth while the lips are slightly in contact with each other (free space) (Patients will be instructed to maintain this relaxed position at all times at rest, except when eating or talking and to avoid involuntary muscle contraction with teeth in central occlusion). Then two weeks, 1 month and 2 months later, the patient will be monitored to ensure that the training is done correctly, and again, similar to the first session, the examination will be done and the severity of the symptoms will be recorded..</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:
After deidentifying the patient's demographic information, the results obtained after the treatment can be shared

When:
The access period starts 6 months after the results are published

To whom:
For researchers working in academic and scientific institutions will be available

Conditions:
After deidentifying the patient's demographic information, the results obtained after the treatment can be shared

Where to obtain:
Faculty of Dentistry, Tehran University of Medical Sciences, Dr. Parmiss Omidsalar

How to obtain:
The access period starts 12 months after receiving the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parmiss Omidsalar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 2290 7161</telephone>
        <email>parmiss.omidsalar@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farzaneh Aghahosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>chool of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 4279 4000</telephone>
        <email>aghahose@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Temporomandibular joint disorder
Earache alone (with NRS=3) or accompanied by at least one of the ear symptoms including tinnitus, ear fullness
having parafunctional habits (such as bruxism during sleep or waking up, biting nails or lips and resting the hand under the chin)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inflammatory and infectious lesions of the ear
Neoplastic lesions of the ear or head and neck
Cystic ear lesions
History of head and neck trauma
History of head and face surgery
pregnancy
neurological disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K07.6H92.0</hc_keyword>
      <hc_keyword>H93.1</hc_keyword>
      <hc_keyword>K07.6</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In patients who have jaw problems and also complain of ear pain, ear fullness or tinnitus, the symptoms of temporomandibular disorders will be examined by a trained examiner and the diagnosis of temporomandibular disorders will be confirmed with the criteria of the RDC-TMD questionnaire and the severity of dysfunction Helkimo's clinical criteria will be registered. Patients are then asked to rate the pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents maximum pain. Tinnitus is evaluated by tinnitus handicap inventory and severity of earache and ear fullness by grading from 0 to 10. After recording symptoms, the necessary "self-care" training will be given in the form of a short seminar, along with skills training provided through demonstrations, exercises between sessions, and structured feedback during sessions and phone calls. Self-care includes: education (about the socio-biology model of TMD, chronic pain, multifaceted aspects of the cause of TMD, management methods, and the logic of self-management), bilateral chewing, limitation of mouth opening (opening the mouth within the range of the patient's pain threshold ), diet control (avoid eating hard food), yawn control (opposite pressure on the back of both hands under the chin), thermal modalities (use of moist heat (twice a day for 20 minutes each time) and ice compresses (1 time and 10 minutes each time) alone or together), massage therapy (touching and caressing the muscles along them), controlling parafunctional behaviors (putting their tongue behind the front teeth of the upper jaw, such as when say "N" and then close your mouth and when the lower jaw was in a resting position, leave a few millimeters of space between the occlusion surfaces of the upper and lower teeth while the lips are slightly in contact with each other (free space) (Patients will be instructed to maintain this relaxed position at all times at rest, except when eating or talking and to avoid involuntary muscle contraction with teeth in central occlusion). Then two weeks, 1 month and 2 months later, the patient will be monitored to ensure that the training is done correctly, and again, similar to the first session, the examination will be done and the severity of the symptoms will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temporomandibular joint disorders. Timepoint: At the beginning of the study and 2 weeks later, the first month, the second month and the third month. Method of measurement: Numerical Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Changes in earache intensity. Timepoint: The beginning of the study, the first 2 weeks, the first month, the second month and the third month. Method of measurement: Numerical Analogue Scale.</sec_outcome>
      <sec_outcome>Changes in tinnitus. Timepoint: The beginning of the study, the first 2 weeks, the first month, the second month and the third month. Method of measurement: tinnitus handicap inventory.</sec_outcome>
      <sec_outcome>Changes in ear fullness. Timepoint: The beginning of the study, the first 2 weeks, the first month, the second month and the third month. Method of measurement: Numerical Analogue Scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-02</approval_date>
        <contact_name>Shcool of Dentistry, Tehran Univrsity of Medical Sciences</contact_name>
        <contact_address>School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
