<?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>IRCT2017082233722N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Anti-inflammatory Efficacy of Cinnamaldehyde Mouthwash Comparing with Chlorhexidine Gluconate Mouthwash in Patients with Gingivitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Anti-inflammatory Efficacy of Cinnamaldehyde Mouthwash Comparing with Chlorhexidine Gluconate Mouthwash in Patients with Gingivitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25936</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The number of sampling is chosen by convenient sampling. After that, by random sampling, one group of samples are located in the first intervention group, another group of samples in the second intervention group, and some in the control group. Each individual is assigned a number and then randomly chosen so the objectivity of the research is reached. Blinding for the study subjects (patients) and those who have run the study (researchers) have been carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: The control group use the mouthwash without medicine (placebo) twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks . Intervention 2: The first intervention group use the cinnamaldehyde mouthwash 1% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks . Intervention 3: The second intervention group use the chlorhexidine mouthwash 0.2% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .</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>Dr Maedeh Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental clinic, Khazar Blvd, Khazar square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3330 2908</telephone>
        <email>salehimaede1165@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Tahereh Molania</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental clinic, Khazar Blvd, Khazar squar</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3330 2908</telephone>
        <email>T_molania117@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being a non-smoker; absence of systemic diseases and pregnancy; having at least 24 teeth excluding third molar; absence of active caries lesions; no use of antibiotics within the previous three months; suffering gingivitis with a probing depth of less than 4mm; positive BOP(Bleeding on probing) and finally ensuring patient cooperation.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Necrotizing ulcerative stomatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group use the mouthwash without medicine (placebo) twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .</i_keyword>
      <i_keyword>The first intervention group use the cinnamaldehyde mouthwash 1% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .</i_keyword>
      <i_keyword>The second intervention group use the chlorhexidine mouthwash 0.2% twice a day (in the morning and in the afternoon) each time 10 milliliter (10 milliliter about two table spoon). They should use it after brushing and flossing the teeth. After using the mouthwash they should refrain from eating and drinking for about one hour. It should be used for 5 weeks .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival index. Timepoint: Before intervention, three weeks after intervention, five weeks after the beginning of intervention. Method of measurement: Periodontal probe.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: Before intervention, three weeks after intervention, five weeks after the beginning of intervention. Method of measurement: Periodontal probe.</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>Vice chancellor for research, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-03</approval_date>
        <contact_name>The ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Mazandaran university of medical science, The martyr Motahhari square, Street teacher Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
