<?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>IRCT20211104052964N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-14</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of mouthwashes  on Salivary PH level</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of two mouthwashes: Tea tree oil _ Alvoevera and Chlorhexidine 0/2 % on Salivary PH level</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: The 20 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 2 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 tea tree oil and aloe vera and chlorhexidine on saliva pH.</study_design>
      <phase>3</phase>
      <hc_freetext>salivary Ph.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera  Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of  Irsha chlorhexidine 0.2%  mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and  color CL.17200-  once in their mouth for 1 minute. Intervention 2: Second Intervention group:  participants rinse 5 milliliter of  Irsha chlorhexidine 0.2%  mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and  color CL.17200-  once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera  Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute.</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>Fatemeh Vahdat Bivarzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First floor, number 5, Golbarg 6 alley, Rangin kaman street, 3rd area, mohammadiyeh</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3491941359</zip>
        <telephone>+98 28 3256 6445</telephone>
        <email>f.vahdatbivarzani@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Vahdat Bivarzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First floor, number 5, Golbarg 6 alley, Rangin kaman street, 3rd area, mohammadiyeh</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3491941359</zip>
        <telephone>+98 28 3256 6445</telephone>
        <email>f.vahdatbivarzani@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Dentistry students of Qazvin University of Medical Sciences in the age range of 18-25 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having systemic diseases affecting saliva such as diabetes, hypertension and thyroid diseases
Smoking and drugs abuse
Taking anticholinergic, antihypertensive, antidepressant drugs
History of radiotherapy
Using intraoral devices such as orthodontic appliance</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera  Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of  Irsha chlorhexidine 0.2%  mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and  color CL.17200-  once in their mouth for 1 minute.</i_keyword>
      <i_keyword>Second Intervention group:  participants rinse 5 milliliter of  Irsha chlorhexidine 0.2%  mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and  color CL.17200-  once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera  Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PH level of saliva. Timepoint: Saliva pH is measured at the beginning of the study and after orange juice and immediately and 20 minutes after using mouthwashes. Method of measurement: Digital PH Meter Device.</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>2021-09-15</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology ,The first sub,Mavedat Alley, Shahid Beheshti Boulevard Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
