<?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>IRCT20161019030377N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-18</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study of effect of three mouthwashes Listerine, Irsha, and Vi one general on the salivary streptococcus mutans level.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of effect of three mouthwashes Listerine, Irsha, and Vi one general on the salivary streptococcus mutans level.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For the first time, the clinical efficacy of Vi One mouthwash in relation to other mouthwashes in reducing salivary streptococcus mutans is being evaluated, Randomization description: The names of all the people who are eligible to enter the research (180 people) are written on separate cards and all are placed in a container, then the people who are drawn out one by one, The research samples (90 people) are randomly divided into three groups of one, two and three. They are written with the letter A, another third with the letter B, and the other third with the letter C, and people are grouped into one, two, or three based on the letter of the selected card, Blinding description: The present study will be single blinded and all mouthwashes are prepared into opaque  bottles of the same volume without any specifications.</study_design>
      <phase>N/A</phase>
      <hc_freetext>salivary streptococcus mutans.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Listeine mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml). Intervention 2: Intervention group: Vi One general mouthwash :Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml). Intervention 3: Intervention group: Irsha mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyedeh Pouya Morovati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177713446</zip>
        <telephone>+98 87 3366 8770</telephone>
        <email>pouyamorovati@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyedeh Pouya Morovati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177713446</zip>
        <telephone>+98 87 3366 8770</telephone>
        <email>pouyamorovati@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Dental Students of Kurdistan University of Medical Sciences
Informed Consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>antibiotic consumption within recent month
fluoride therapy within recent month
orthodontic appliance
immune- compromised condition like Diabetic patients
soft tissue oral pathology like PGCG etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Listeine mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).</i_keyword>
      <i_keyword>Intervention group: Vi One general mouthwash :Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).</i_keyword>
      <i_keyword>Intervention group: Irsha mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of salivary streptococcus mutans. Timepoint: 2weeks. Method of measurement: Samples are asked to use mouthwash once a day for 2 weeks and after consuming mouthwash for at least 30 minutes to refrain from consuming any food and beverages as well as mouth washing. Saliva samples are taken from all participants before and after mouthwash. The sampling method is to ask them to rinse their mouths with saline before eating breakfast and brushing their teeth. Then 1 cc of non-stimulating saliva is collected by spitting in a sterile tube and immediately sent to the laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-11</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
