<?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>IRCT20171020036896N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-04</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Green tea, Chlorhexidine and green coffee extract on salivary Streptococcus mutans</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>Comparison of  the effect of metanolic green tea، green coffee extract and chlorhexidine and on the salivary Streptococcus mutans ُin preschool children with early childhood caries  by the PCR</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27450</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization or unrestricted    method will be used and randomization unit is Individual .we will use from Roll of a die from the methods of  simple randomization because there are 3 groups in this study that actually the tool of randomization is dice. So the  numbers 1 and 2 are for the first group (chlorhexidine) 3 and 4 for the second group (green coffee) and 5 and 6 for the third (green tea). The next step Allocation concealment  will be done, In such a way that the allocated group is not known before the assignment of the individual. To achieve this goal, a non-transparent, sealed, random sequence envelope is used . In this way, the statistical specialist will provide 90 envelopes and each of the randomly generated links will be recorded on a card  and the cards are arranged in the envelopes . In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the envelops are enclosed and placed in the box, respectively. At the time of the implementation of the study, according to the order of entry of eligible participants, one of the envelopes is opened respectively and  will determine the group assigned to that participant. In this study, the assistant of Pediatric Dentistry examines the participants in terms of inclusion and exclusion criteria. Randomization methods are done by an statistical specialist  and performance of the study  is done by a trained dental student, Blinding description: Because all the materials are in the same consistency gel, in a uniform shape and color,  considering the informed consent, participants are unaware of material. Outcome evaluator, who performs PCR, is also unaware of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Streptococcus mutans.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Green tea methanolic extract 20%, for 30 minutes and 1 week after saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child. Intervention 2: Intervention group: Green coffee 10% , for 30 minutes and 1 week after  saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child. Intervention 3: Control group: Chlorhexidine 0.2% , 30 minutes and 1 week after  saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.</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 Because the study data do not have any other scientific application.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Hamidreza Poureslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, School of Dentistry, Shafa street, Kerman</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+34 32119021</telephone>
        <email>poureslami@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh sadat Sajadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, School of Dentistry, Shafa street, Kerman</address>
        <city>کرمان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>sajadi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Preschoolers aged 4 to 6 years</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Usage of gum containing xyllitol
Soft tissue lesion in the mouth
Use orthodontic appliances
The presence of systemic disease
Take antibiotics and topical fluoride over the past month
Presense of active and severe periodontal disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>پوسیدگی دندانی</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:Green tea methanolic extract 20%, for 30 minutes and 1 week after saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.</i_keyword>
      <i_keyword>Intervention group: Green coffee 10% , for 30 minutes and 1 week after  saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.</i_keyword>
      <i_keyword>Control group: Chlorhexidine 0.2% , 30 minutes and 1 week after  saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Streptococcus mutans. Timepoint: 30 minutes and 1 week later application of interventions. Method of measurement: PCR.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-24</approval_date>
        <contact_name>The Ethic Committee of kerman University of Medical Sciencess</contact_name>
        <contact_address>Vice-Chancellor  for Research, Building of Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
