<?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>IRCT20201213049704N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-11</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study on  effect  of Alpha danan and sensodyne toothpastes on pH salivary chang.</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on  effect  of Alpha danan and sensodyne toothpastes on pH salivary chang.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53218</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: The names of the people who are eligible to enter the research are written on separate cards and we put them all in a pot, then the people who are pulled out one by one, form the research samples that Simple random forms are divided into groups one and two, for this purpose, according to the number of sample people, we put cards in the pot on which we write the number one and the other half number two, and the people based on their card number in There are one or two groups (depending on the type of study (cross-clinical trial), each person is measured against himself / herself, so there is no need to match the groups in terms of age and gender), Blinding description: Blinding participants: To eliminate bias, we use double-blind, for this purpose, two types of toothpaste are poured into similar white tubes so that it is not possible to identify the type of toothpaste by the samples and the amount of error and Minimize orientation.

Outcome Evaluation Blindness: The pH measurement with a pH meter is performed by a research student who has acquired the necessary skills to do so and is unaware of the type of toothpaste used by the samples.</study_design>
      <phase>4</phase>
      <hc_freetext>Dental caries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Group I (half of the study volume, which uses alpha toothpaste in the first intervention and toothpaste under the brand name Sensodyne in the second intervention (72 hours later)). Group two (half of the study volume that used toothpaste under the brand name Sensodyne in the first intervention and alpha toothpaste in the second intervention (72 hours later).). Intervention 2: Control group: According to the type of study (crossover clinical trial), each person is measured against himself. In other words, the intervention groups at each stage are their control group for the next intervention.</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 discussion has been held with the tutor in this regard yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Rastegar Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617939438</zip>
        <telephone>+98 87 3559 1128</telephone>
        <email>bababarbod@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Rastegar Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Blvd</address>
        <city>Sanadaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617939438</zip>
        <telephone>+98 87 3559 1128</telephone>
        <email>bababarbod@gamil.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Samples are among the students of Sanandaj Dental School.
Samples complete the consent form.
Be in the age group of 35-18 years.
. The specimens do not have systemic diseases that affect saliva, such as diabetes, asthma, kidney and liver failure, epilepsy, blood and glandular disorders.
. Samples do not have removable orthodontic appliances and prostheses.
Samples have not recently undergone radiotherapy.
Samples are not smokers.
Samples Do not use antihypertensive drugs and antibiotics regularly.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Samples are allergic to toothpaste compounds.
2. If you do not participate in the second stage of intervention.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Group I (half of the study volume, which uses alpha toothpaste in the first intervention and toothpaste under the brand name Sensodyne in the second intervention (72 hours later)). Group two (half of the study volume that used toothpaste under the brand name Sensodyne in the first intervention and alpha toothpaste in the second intervention (72 hours later).)</i_keyword>
      <i_keyword>Control group: According to the type of study (crossover clinical trial), each person is measured against himself. In other words, the intervention groups at each stage are their control group for the next intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Saliva pH. Timepoint: In the first intervention: before brushing with toothpaste and after brushing with toothpaste. 72 hours later, perform the second intervention: before brushing with toothpaste and after brushing with toothpaste. Method of measurement: PH meter model pH meter BASIC 20+.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-16</approval_date>
        <contact_name>Ethics committee of kurdestan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan Besat Medical Sciences Dormitory, Above Jam Jam Crossroads, Adab Street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
