<?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>IRCT20160903029651N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-04</date_registration>
      <primary_sponsor>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry</primary_sponsor>
      <public_title>The effect of Vitamin C on salivary antioxidant level in patients with bruxism (gnash)</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of  Vitamin C on the Level of Salivary Total Antioxidant Capacity(TAC) in bruxism patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23776</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was done individually through a sealed envelope and the manner of creating random sequences was through draw, Blinding description: In order to blinding, the medications were put into boxes of one color and one form, and the difference was the code on which they were inserted; the list was kept hidden by clinical caregiver until decoded.</study_design>
      <phase>3</phase>
      <hc_freetext>bruxism.</hc_freetext>
      <i_freetext>Intervention 1: Chewing Vitamin C  250 mg/day with the taste of cherry of Osweh Companyو chew one of them daily for a month in the morning (30 days). Intervention 2: Chewing Placebo (Similst to Vitamin C)250 mg/day with the taste of cherry of Osweh Company, chew one of them daily for a month in the morning (30 days).</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 Effect of vitamin C in the level of total antioxidant saliva in patients with bruxism and the consequences resulting from it such as pain relief, only part of the data, such as information on the primary and secondary consequences, can be shared.

When:
It will be available one year after publishing

To whom:
Researchers working in the field of dentistry and medicine

Conditions:
Any analysis of the data is not allowed and only the documentation is used to obtain its results in order to help other studies.

Where to obtain:
Doctor Shamsoulmolouk Najafi, Najafi_sh@tums.ac.ir
Hodays Yeganehfard, Yhodais@yahoo.com

How to obtain:
At first, an email is sent to the requested people and we waited 3 to 10 days to submit the file

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shamsoulmolouk Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1894787549</zip>
        <telephone>+98 21 5585 1149</telephone>
        <email>Najafi_sh@tums.ac.ir</email>
        <affiliation>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shamsoulmolouk Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1894787549</zip>
        <telephone>+98 21 5585 1149</telephone>
        <email>Najafi_sh@tums.ac.ir</email>
        <affiliation>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Our diagnostic criteria for bruxism is considered based on ICSD-R:  1. Symptoms indicating grinding teeth on each other while sleeping                                                                                                     2. Abnormal grinding of teeth                                                             3. Sound of grinding teeth                                                                  4. Discomfort of jaw muscle                                                             As well as other symptoms stated by Murali:                 1. Toothpicking                                                                                          2. Fatigue of masticatory muscles                                                     3. Recurrent migraines                                                                         4. Broken Dental fillings or splint                                                 5.Ulceration of denture underlying mucosa                                      6. Sensitivity to percussion                                                                 7. Increase in the size of the Temporal and Masseter muscles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who have the following features are removed from the list: 1. Record of severe trauma and dental surgeries                            2. Clinical record of functional disorder (depression and anxiety)and sleep disorders (Apnea and Insomnia)                              3. Moderate to high consumption of alcohol and cigarettes                4. Systemic problems (diseases of kidney and liver, thyroid and diabetes) and cancer, pregnant and nursing mothers                      5. Taking drugs (Glucocorticoids or Selective Serotonin, edible contraceptives, variety of Antioxidants,Folic acid, Allopurinol such as Zenthine Oxidase Inhibitor)                                                            6. Epilepsy or neurological disorders such as Parkinson’s and Alzheimer’s                                                                                               7. Infectious diseases                                                                                          8.  Those who had taken muscle relaxing drugs such as Benzodiazepines                                                                                           9. Neuromuscular disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Any other disorders of sensation, function and behaviour, not due to physical disorders, which are not mediated through the autonomic nervous system, which are limited to specific systems or parts of the body, and which are closely associated in time with</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Chewing Vitamin C  250 mg/day with the taste of cherry of Osweh Companyو chew one of them daily for a month in the morning (30 days).</i_keyword>
      <i_keyword>Chewing Placebo (Similst to Vitamin C)250 mg/day with the taste of cherry of Osweh Company, chew one of them daily for a month in the morning (30 days).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes the level of Total Antioxidants Capacity (TAC) of stimulated and unstimulated saliva. Timepoint: Before intervention and one month after. Method of measurement: Taking 1 ml stimulated and unstimulated saliva samples and measurement of total antioxidant capacity by the ZellBio GmBh (CAT No. ZB-TAC-96A) and (CAT No. ZB-TAC-48A) kits through oxidation-reduction calorimetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score of myofascial pain associated with bruxism. Timepoint: Before intervention and one month after. Method of measurement: Numeric Scale Rating (NRS).</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>International Campus Branch, Tehran University of Medical Sciences, School of Dentistry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-21</approval_date>
        <contact_name>Ethics Committee of Dentistry school of Tehran university of medical science</contact_name>
        <contact_address>Tehran University of Medical Sciences  of Dentistry  School, next to Hakim Highway, up to Atomic Energy Organization, end of Kargar Shomali Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
