<?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>IRCT20101006004877N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Faculty of Dentistry, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of hydrogen peroxide and zinc mouth-wash in reducing gingival inflammation</public_title>
      <acronym></acronym>
      <scientific_title>Effect of hydrogen peroxide and zinc mouth-wash on periodontal indices in patients with chronic gingivitis in randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58204</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is based on simple decomposition method which is done by lottery method. In this way, 44 envelopes are sealed, in which the four codes related to each of the experimental groups are prepared, and each participant randomly selects one of these envelopes and The base of the code inside the envelope is in one of the test groups, Blinding description: In three groups that take mouthwash , mouthwash in the same battles but for reducing ignores , corks of battle manufacturing in three colors. The colors have a code that just researcher have known the codes refer to what kind of mouthwash.</study_design>
      <phase>3</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: This group is considered as a positive control group and people in this group will not use mouthwash. Intervention 2: Intervention group: People in this group are asked to use 0.2% chlorhexidine mouthwash twice a day at a rate of 5 ml for 2 weeks. Intervention 3: Second Intervention group: In this group, people are asked to use 5 ml of hydrogen peroxide mouthwash twice a day for 2 weeks. Intervention 4: third Intervention group: In this group, people are asked to use placebo mouthwash twice a day in the amount of 5 ml for 2 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>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>Jaber Yaghini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, ‌Dental School</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5542</telephone>
        <email>J_yaghini@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaber Yaghini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, ‌Dental School</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5564</telephone>
        <email>J_yaghini@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>15 functional teeth at least
Gingivitis in gingival. ( gingival index at least 2 or more )
Don’t use alcohol and cigarettes
non-existence of systemic diseases that effect gingiva condition l
Don’t use drugs that effect periodontal condition
Non-existence of periodontal surgery or condition that effect periodontal diseases</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>64 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with dental anomalies
People over the age of 65
People with a history of orthodontic treatment
People with a history of bleaching treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: This group is considered as a positive control group and people in this group will not use mouthwash.</i_keyword>
      <i_keyword>Intervention group: People in this group are asked to use 0.2% chlorhexidine mouthwash twice a day at a rate of 5 ml for 2 weeks.</i_keyword>
      <i_keyword>Second Intervention group: In this group, people are asked to use 5 ml of hydrogen peroxide mouthwash twice a day for 2 weeks.</i_keyword>
      <i_keyword>third Intervention group: In this group, people are asked to use placebo mouthwash twice a day in the amount of 5 ml for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease in probing death. Timepoint: In the beginning of research- 2 weeks- 6 weeks- 3 months. Method of measurement: By periodontal probe in the mid buccal tooth gingival.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: In the beginning of research- 2 weeks- 6 weeks- 3 months. Method of measurement: For indicating plaque index , using silness&amp;leo plaque index . In this index , 0  demonstrative no microbial plaque , 1 demonstrative a thin layer of plaque in around of free marginal gingival, 2 demonstrative the medium amount of plaque in gingival sulcus and 3 demonstrative large amount of plaque in sulcus or periodontal pocket till free gingival margin.</prim_outcome>
      <prim_outcome>Probing bleeding index. Timepoint: In the beginning of research- 2 weeks- 6 weeks- 3 months. Method of measurement: In this criterion, zero indicates the absence of bleeding, one indicates the presence of a specific bleeding point, two indicates the presence of isolated bleeding points in several cases or the presence of a single line of bleeding, three indicates that after probing the triangle between A tooth is immediately filled with blood, and a score of 4 in this index indicates heavy bleeding after probing, which immediately flows into the marginal sulcus.</prim_outcome>
      <prim_outcome>Gingival index. Timepoint: In the beginning of research- 2 weeks- 6 weeks- 3 months. Method of measurement: To determine the gingivitis index (GI) of patients, the 4-part Leo &amp; Silness criterion is used, in which zero indicates normal gingiva, one indicates mild inflammation (slight changes in color and mild edema with bleeding during probing), two indicates moderate inflammation. Along with edema redness and bleeding during probing and three also indicate severe inflammation with severe edema redness and ulceration and tendency to bleed simultaneously.</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, Faculty of Dentistry, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-23</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Ethics Committee isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
