<?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>IRCT20180915041041N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-01</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Barrow Oral Care Protocol on Oral Health in Patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Barrow Oral Care Protocol on Oral Health in Patients Undergoing Mechanical Ventilation Admitted in the Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permuted Block Randomization.  To randomly assign patients to two, 6 blocks of size  4 were used. 
In this randomization, letter A was used to call routine group and letter B was used to name patients in the intervention group. Each block contains 4 alternatives. 
Block 1:         A A B B
Block  2:        A B A B
Block 3:         A B B A 
Block 4:         B B A A
Block 5:         B A B A
Block 6:         B A A B 
Then, with six presumptive blocks, six numbers (1 to 6) were selected. Based on sample size of 90 patients, 23 blocks were randomly selected until reaching sample size of 90 patients. Finally, 45 patients were allocated to each groups, Blinding description: Because the randomization was performed by the original researcher, only the researcher was aware of the patients' care methods according to the relevant code, and the rest of the people, including the participating patient or the patient's legal guardian, only agreed to get care and were unaware of the type of care. The patient's oral assessor evaluated and recorded the patient's oral health only on a daily basis in a form that included a table of clinical oral health assessment tools used for both intervention and control groups and did not know the type of care in each group. And the counselor is also unaware of how to code for patients They were.</study_design>
      <phase>3</phase>
      <hc_freetext>Respiratory failure.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group":in this group, care was started based on Barrow Oral Care Protocol and continued for 5 consecutive days. The protocol suggests three types of oral care based on the patient's oral health assessment score based on the clinical assessment of oral health (BOE) during admission.For patients with good oral health with an oral health score (BOE 8-10), the basic protocol of oral care includes washing the tongue using saline, brushing with a toothbrush and toothpaste, and rubbing a thin layer of Vaseline ointment. It is applied on the lips every 12 hours a day. In patients with moderate oral health status with oral and dental health score (BOE 11—14), in addition to basic oral care according to the main protocol, oral mucosal care, which includes rinsing the mouth with a wet swab with chlorhexidine chloride solution 0.2% and using Mucosamine moisturizing spray was added to the patient's oral care every 4 hours, and in patients with poor oral health status with an oral health score (15 to 24), in addition to oral care every 12 hours, oral mucosal care was evaluated every two hours. At the beginning of the patient's daily admission, the patient's oral and dental health status was monitored and evaluated by the evaluator, and the nurse who cared for the patient's mouth and teeth took care of the patient based on the new score. Intervention 2: Control group: In this group, after determining and recording the patient's oral health score based on the clinical oral health assessment tool (BOE) on the first day of admission, taking care of the patient's oral health, according to the routines of the ward including rinsing the patient's mouth in each shift using gas soaked in solution Chlorhexidine 0.2%, was started by the patient's nurse and continued for 5 consecutive days. At the beginning of the patient's admission and every day after that, the patient's oral health status was checked by the evaluator, and the nurse in charge of the patient's care performed the patient's oral health care according to the routines of ward without attention to the patient's oral health score.</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:
Thesis

When:
Always

To whom:
researchers

Conditions:
For use in research

Where to obtain:
Ardabil University of Medical Sciences

How to obtain:
Written Request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Robab Javanmard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 340, opposite Bank of Commerce, Neighborhood of Imam, Shohada Highway</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5616657115</zip>
        <telephone>+98 45 3345 9644</telephone>
        <email>javanmard_1354@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mamood Shamshiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, before the Saadi bridge, after the Hafez intersection</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615751147</zip>
        <telephone>+98 45 3372 6085</telephone>
        <email>mahmood.shamshiri@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients admitted to intensive care units (ICU)
Patients undergoing mechanical ventilation.
Patients aged 15 to 45 years</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of the patient's legal guardian
Patients with facial trauma
Having previous underlying disease such as diabetes, asthma, kidney failure, heart, liver,
Patients undergoing chemotherapy or treatment with  corticosteroids
Patients previously undergoing transplantation of one of the vital organs of the body, such as the heart, kidney, liver and pancreas.
Patients treated with Immunosuppressants
Patients with blood diseases such as hemophilia,Thalassemia, leukemia, , platelet deficiency or any of the blood cells
Patients with severe infection and sepsis
Patients with scalp and neck burns</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory failure, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group":in this group, care was started based on Barrow Oral Care Protocol and continued for 5 consecutive days. The protocol suggests three types of oral care based on the patient's oral health assessment score based on the clinical assessment of oral health (BOE) during admission.For patients with good oral health with an oral health score (BOE 8-10), the basic protocol of oral care includes washing the tongue using saline, brushing with a toothbrush and toothpaste, and rubbing a thin layer of Vaseline ointment. It is applied on the lips every 12 hours a day. In patients with moderate oral health status with oral and dental health score (BOE 11—14), in addition to basic oral care according to the main protocol, oral mucosal care, which includes rinsing the mouth with a wet swab with chlorhexidine chloride solution 0.2% and using Mucosamine moisturizing spray was added to the patient's oral care every 4 hours, and in patients with poor oral health status with an oral health score (15 to 24), in addition to oral care every 12 hours, oral mucosal care was evaluated every two hours. At the beginning of the patient's daily admission, the patient's oral and dental health status was monitored and evaluated by the evaluator, and the nurse who cared for the patient's mouth and teeth took care of the patient based on the new score.</i_keyword>
      <i_keyword>Control group: In this group, after determining and recording the patient's oral health score based on the clinical oral health assessment tool (BOE) on the first day of admission, taking care of the patient's oral health, according to the routines of the ward including rinsing the patient's mouth in each shift using gas soaked in solution Chlorhexidine 0.2%, was started by the patient's nurse and continued for 5 consecutive days. At the beginning of the patient's admission and every day after that, the patient's oral health status was checked by the evaluator, and the nurse in charge of the patient's care performed the patient's oral health care according to the routines of ward without attention to the patient's oral health score.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral health status. Timepoint: Oral Health Assessment at the beginning of the study, daily and completion of the study. Method of measurement: Scale BOE(Bed side Oral Exame).</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-26</approval_date>
        <contact_name>Ethics committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Student Research Committee, Ardabil University of Medical Sciences, Above Shorabil Lake, Daneshgah street, Ardabil Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
