<?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>IRCT2016020626402N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-29</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Mouthwash impact on oral hygiene ICU patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of green tea and chlorhexidine mouthwash on oral hygiene and bacterial colonies in intubated patients admitted to the intensive care unit.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21896</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mucositis.</hc_freetext>
      <i_freetext>According to the crossover method, the first group in the first 4 days with chlorhexidine solution mouthwash and 4 second days with a solution of green tea and the second group first 4 days with a solution of green tea and 4 second days with chlorhexidine solution mouthwash done. In this study patients (cases) their own controls Are. The first group in the first place by using chlorhexidine solution and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution of chlorhexidine 2% in the oral cavity molding and after mouthwash green tea 5% mouthwash will thus using a solution of mouthwash green tea and a soft toothbrush levels tongue and teeth from back to front and rotational movements dirty will be cleaned at the end of day 8, recultivation from the throat of the patient is sent. In all the steps and distance between Beck and MPS mouthwash oral health assessment form will be filled. In the second group in the first stage using a solution of green tea and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution mouthwash green tea 5% in the oral cavity molding and after a suction minutes throat and mouth area is performed the steps of the work for twice daily and continues for four days and again at the end of the fourth day of culture sterile technique taken from the throat area and will be sent to the shahid mohammadi hospital laboratory and the complete check list is oral hygiene. In the second phase patient for 4 days with chlorhexidine solution and a soft toothbrush and tongue from back to front tooth surfaces can be cleaned with rotational movements followed by 10 cc of spilled solution of chlorhexidine in the oral cavity and pharyngeal area and after a minute oral suction is performed. At the end of day 8 of culture from the throat to sterile technique and will be sent to the laboratory..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yaser khanchemehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman ، Razi Nursing College</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3132 5177</telephone>
        <email>yaserkhanchemehr@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hakimeh Hossein Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman Nursing College</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3132 5177</telephone>
        <email>h_m5664@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patient is intubated through the mouth؛ aged 65-18 years؛ less than 12 hours of ICU admission time in the past؛ before admission to the special section on the other sections have been admitted؛ avoiding the use of antibiotics before admission؛ birth control؛ no history of allergy to herbal substances؛ lack of dentures؛ lack of chronic disease and lack of immune disorder؛ the absence of any damage identified by intubation endotracheal or euros and not unknown in the mouth and around the mouth.&#13;
 Exclusion criteria : The transfer of the patient from the ICU؛ died before completing his studies؛ doing any harm identified by intubation or planes or any other physical factors and not wanting to continue the study of the legal guardian of the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis (ulcerative)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>According to the crossover method, the first group in the first 4 days with chlorhexidine solution mouthwash and 4 second days with a solution of green tea and the second group first 4 days with a solution of green tea and 4 second days with chlorhexidine solution mouthwash done. In this study patients (cases) their own controls Are. The first group in the first place by using chlorhexidine solution and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution of chlorhexidine 2% in the oral cavity molding and after mouthwash green tea 5% mouthwash will thus using a solution of mouthwash green tea and a soft toothbrush levels tongue and teeth from back to front and rotational movements dirty will be cleaned at the end of day 8, recultivation from the throat of the patient is sent. In all the steps and distance between Beck and MPS mouthwash oral health assessment form will be filled. In the second group in the first stage using a solution of green tea and a soft toothbrush tooth surfaces and tongue from back to front and rotational movements cleaned, followed by 10 ml of solution mouthwash green tea 5% in the oral cavity molding and after a suction minutes throat and mouth area is performed the steps of the work for twice daily and continues for four days and again at the end of the fourth day of culture sterile technique taken from the throat area and will be sent to the shahid mohammadi hospital laboratory and the complete check list is oral hygiene. In the second phase patient for 4 days with chlorhexidine solution and a soft toothbrush and tongue from back to front tooth surfaces can be cleaned with rotational movements followed by 10 cc of spilled solution of chlorhexidine in the oral cavity and pharyngeal area and after a minute oral suction is performed. At the end of day 8 of culture from the throat to sterile technique and will be sent to the laboratory.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral hygiene. Timepoint: The first day of intervention and fourth day of intervention and eighth day of intervention. Method of measurement: Beck oral assessment Scale And Culture of throat secretions.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mouth and throat infection، Plaque. Timepoint: The first day of intervention and fourth day of intervention and eighth day of intervention. Method of measurement: Culture of throat secretions، mucosal plaque score.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-05</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Central organization of Kerman University of Medical Sciences - After shafa crossroad - Islamic republic boulevard - Kerman - Iran Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
