<?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>IRCT20221030056345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-16</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant  on  the count of Streptococcus mutans settled on removable orthodontic appliances</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant  on  the count of Streptococcus mutans settled on removable orthodontic appliances</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70718</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>1-2</phase>
      <hc_freetext>the count of Streptococcus mutans settled on removable orthodontic appliances.</hc_freetext>
      <i_freetext>Intervention 1: Control: Distilled water-ph=6.5-7.5-TDS=0.00ppm-CL=0.00-once for 30 participants in a 10-day period-after removing the movable orthodontic plate from the mouth, the participant will immerse it in a container containing distilled water. and to put it back in the mouth, he will use tweezers to remove the mobile plaque from distilled water. After 10 days, the solution will be cultured - Sina Noor Company. Intervention 2: First Intervention: The first intervention group: Chlorhexidine 0.2% - mouthwash - every 100 ml containing: chlorhexidine gluconate 0.2 g + 10% ethanol - Najo company - the participant for 10 days after removing the removable orthodontic plate from the mouth, put it in a container containing Chlorhexidine mouthwash will be immersed and forceps will be used to remove the mobile plaque from the mouthwash to put it back in the mouth. After 10 days, the solution will be cultured. Intervention 3: Second Intervention: Ethanol extract of pecan plant-combination: 600 grams of pecan is prepared for the preparation of herbal mouthwash. After washing and drying, the fruit and seeds of the plant will be separated and ground with a grinder. The resulting powder is poured into a container and Its surface is completely covered with 96% ethanol and it remains in this state for 48 hours. Then the resulting mixture is placed in the oven. After 72 hours, when the solution remains in the oven, the solution is removed from the machine and passed through filter paper. Then the resulting solution is placed in the rotary device little by little and several times. And in this way, the alcohol is separated from the solution and a liquid is obtained, which after drying will be the same pecan plant extract that is used to prepare Different concentrations will be dissolved in normal saline serum.-The concentration used in the study will be lower than MTT (the highest value obtained from MIC determination) - the participant will immerse the movable orthodontic plate in a container containing pecan plant mouthwash for 10 days after removing it from the mouth. Placing it back in the mouth will use forceps to remove the moving plaque from the solution. After 10 days, the solution will be cultured.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Without mentioning the name of the participants, the amount of MIC and MBC of the plant extract and cfu obtained from the three materials used will be shared.

When:
The access period will start 1 year after the results are published

To whom:
The data will be accessible to researchers working in academic and scientific institutions and students interested in research

Conditions:
Data access is allowed if researchers use them to increase awareness and interest in conducting further studies

Where to obtain:
Email address: doctorfj1999@yahoo.com

How to obtain:
Applicants should include researchers working in academic and scientific institutions or students who, after sending the documents to the email address doctorfj1999@yahoo.com and mentioning the purpose of the data study, the result will be sent to them via email within 2-3 months at most. becomes

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Jafarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirkabir</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931836116</zip>
        <telephone>+98 84 3385 3746</telephone>
        <email>doctorfj99@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Jafarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirkabir</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931836116</zip>
        <telephone>+98 84 3385 3746</telephone>
        <email>doctorfj99@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent of participants to participate in the study
Retainer prescription by an orthodontic specialist
Age 20-60 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active periodontal disease
History of using chlorhexidine mouthwash during the last two weeks</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>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control: Distilled water-ph=6.5-7.5-TDS=0.00ppm-CL=0.00-once for 30 participants in a 10-day period-after removing the movable orthodontic plate from the mouth, the participant will immerse it in a container containing distilled water. and to put it back in the mouth, he will use tweezers to remove the mobile plaque from distilled water. After 10 days, the solution will be cultured - Sina Noor Company</i_keyword>
      <i_keyword>First Intervention: The first intervention group: Chlorhexidine 0.2% - mouthwash - every 100 ml containing: chlorhexidine gluconate 0.2 g + 10% ethanol - Najo company - the participant for 10 days after removing the removable orthodontic plate from the mouth, put it in a container containing Chlorhexidine mouthwash will be immersed and forceps will be used to remove the mobile plaque from the mouthwash to put it back in the mouth. After 10 days, the solution will be cultured.</i_keyword>
      <i_keyword>Second Intervention: Ethanol extract of pecan plant-combination: 600 grams of pecan is prepared for the preparation of herbal mouthwash. After washing and drying, the fruit and seeds of the plant will be separated and ground with a grinder. The resulting powder is poured into a container and Its surface is completely covered with 96% ethanol and it remains in this state for 48 hours. Then the resulting mixture is placed in the oven. After 72 hours, when the solution remains in the oven, the solution is removed from the machine and passed through filter paper. Then the resulting solution is placed in the rotary device little by little and several times. And in this way, the alcohol is separated from the solution and a liquid is obtained, which after drying will be the same pecan plant extract that is used to prepare Different concentrations will be dissolved in normal saline serum.-The concentration used in the study will be lower than MTT (the highest value obtained from MIC determination) - the participant will immerse the movable orthodontic plate in a container containing pecan plant mouthwash for 10 days after removing it from the mouth. Placing it back in the mouth will use forceps to remove the moving plaque from the solution. After 10 days, the solution will be cultured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Count of Streptococcus mutans settled on removable orthodontic appliances. Timepoint: 10 days after the intervention. Method of measurement: Through microbial culture and colony counting.</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>ilam university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-17</approval_date>
        <contact_name>Research ethics committees of ilam university of medical sciences</contact_name>
        <contact_address>Pardis of Ilam University of Medical Sciences  ,Paghoohesh Blvd,Banganjab,Ilam Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
