<?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>IRCT20220621055244N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-04</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of ginger mouthwash on plaque index and gingival index</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of ginger mouthwash on plaque index and gingival index : A randomized double_- blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64392</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The 50 participants of the study are divided into two groups A and B using random allocation software using random block method. The size of each block is 5 and the total number of blocks is 10.Balanced random allocation method for participants in a randomized clinical trial study is used to evaluate the effect of two mouthwashes of ginger and chlorhexidine on PI and GI in 2 weeks, Blinding description: The participants do not know about the difference between mouthwashes. Researcher and the examiner do not know that each person belongs to which group.</study_design>
      <phase>3</phase>
      <hc_freetext>Plaque Index / Gingival Index.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Use ginger mouthwash twice a day for one minute for two weeks. Vi one Ginger mouthwash contains deionized water, ginger extract, glycerin, polyethylene glycol 40, xylitol, potassium sorbate, ploxamer 407, citric acid, menthol, sodium saccharin. Intervention 2: Control group:  Use Chlorhexidine mouthwash twice a day for one minute for two weeks. Chlorhexidine mouthwash 0.2% vi One contains deionized water, sorbitol, glycerin, polyethylene glycol, xylitol, polysorbate 20, ploxamer 407, citric acid, menthol, chlorhexidine digluconate 0.2%, essential oil.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shabnam Haftani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No198, Qasaban Alley, Shahed Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1656667161</zip>
        <telephone>+98 21 7734 8984</telephone>
        <email>shabnam.haftani@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shabnam Haftani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No198, Qasaban Alley, Shahed Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1656667161</zip>
        <telephone>+98 21 7734 8984</telephone>
        <email>shabnam.haftani@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students of Qazvin University of Medical Sciences in the age range of 18-45 years
Having 20 teeth at least
Having no periodontal diseases
Not having pocket depth more than 3 mm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having systemic diseases affecting oral health such as diabetes , hypertension, thyroid diseases
Having the history of periodontal or oral surgeries
Pregnant or milch womens
Taking anticholinergic, antihypertensions, antidepressant drugs and history of radiotherapy
Using intraoral devices such as orthodontics appliences</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Use ginger mouthwash twice a day for one minute for two weeks. Vi one Ginger mouthwash contains deionized water, ginger extract, glycerin, polyethylene glycol 40, xylitol, potassium sorbate, ploxamer 407, citric acid, menthol, sodium saccharin</i_keyword>
      <i_keyword>Control group:  Use Chlorhexidine mouthwash twice a day for one minute for two weeks. Chlorhexidine mouthwash 0.2% vi One contains deionized water, sorbitol, glycerin, polyethylene glycol, xylitol, polysorbate 20, ploxamer 407, citric acid, menthol, chlorhexidine digluconate 0.2%, essential oil</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plaque Index and Gingival Index. Timepoint: Once at the beginning of the work, once on the 7th intervention day and once on the 14th intervention day. Method of measurement: The plaque index is identified at each stage using a fuchsin tablet that is chewed in the mouth for 1 minutes. This index is measured in accordance with the Quigley-Hein Turesky modification index. In this way, the buccal and lingual (palatal) surfaces of all teeth are first obtained according to the following numbers and their average is considered as the index of each tooth. By summing the indices of all teeth and dividing them by the number of teeth, the plaque index in the patient is calculated. Based on the number of license plates, one of the following six points is considered for each level:Score zero: the surface is without plates. Score 1: Plaque should be scattered in the cervical part of the tooth. Score 1: The plaque should be in the form of a thin continuous line with a maximum thickness of 1 mm in the cervical tooth. Score 1: Plaque more than 2 mm thick but less than one third of the tooth crown is covered. Score 1: The plaque is more than one third thick but less than two thirds of the tooth crown. Score 2: Plaque covers two-thirds or more of the tooth crown.The gingival index is recorded by the examiner by observing the appearance of the gingiva and also by using the Williams probe. The loe &amp; silness method is used to examine the gingival index (Gingival index GI). The gingiva of each tooth are divided into 4 parts: mesiobuccal papilla, distobuccal papilla, midbuccal gingival margin and midlingual gingival margin and then evaluated and based on the results obtained, they are given one of the following four points:Score 0: If the gingiva have a normal appearance and are free of inflammation and bleeding. Score 1: low inflammation, slight discoloration, low edema, no bleeding during probing. Probing. Score 3: Severe inflammation, marked redness, edema and hypertrophy, ulcers and spontaneous bleeding. To achieve the GI of each tooth, the average GI of all surfaces of that tooth is considered, and to achieve the total oral GI, the average GI of all the examined teeth is considered.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-22</approval_date>
        <contact_name>Ethics Commite of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Deputy o Research and Technology , The first sub , Mavedat Alley , Shahid Beheshti Boulvard Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
