<?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>IRCT20220424054642N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-31</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of anti-Bacterial effect of dental varnish fortified with nano-bioactive glass contains Strontium and Cobalt</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of anti-Bacterial effect of dental varnish fortified with nano-bioactive glass contains Strontium and Cobalt on permanent tooth: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65405</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Randomization will be done in a simple way with the help of a table of random numbers. For each even number, code A is assigned to apply varnish on the right premolar tooth, and for each odd number, code B is assigned to apply varnish to the left premolar tooth. Finally, a random chain of 21 letters A and B is formed with a random sequence. Cards A and B will be placed in the envelopes with numbers 1 to 21 in the order obtained, and upon the arrival of each patient who is eligible for the study, the corresponding envelope will be opened and the treatment group for that patient will be determined, Blinding description: In order to blind the participant, according to the assigned treatment group, in addition to applying varnish on the premolar tooth of the corresponding side, the same treatment method with distilled water will be applied to the corresponding premolar tooth of the opposite side.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Dental caries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: recipient of dental varnish reinforced with nano-bioactive glass containing strontium and cobalt on the buccal surface of premolar teeth. Both premolar teeth in the intervention and control groups were extracted after 4 weeks. Intervention 2: Control group: Control group: without receiving varnish on the premolar tooth, which receives distilled water for blinding. Both premolar teeth in the intervention and control groups were extracted after 4 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After extraction, the studied teeth are measured for the number of mutans streptococci. This data can be shared after de-identifying individuals.

When:
It is expected that the required data will be collected in February 1401 and will be accessible from that date.

To whom:
Considering that this study will be done in the form of a student thesis, I think it will be available for researchers working in academic institutions.

Conditions:
We have no limits for this work

Where to obtain:
I, Shaghaig Golshani, will be available to provide documentation
 sh.golshani@edu.umsha.ac.ir

How to obtain:
The applicant should describe the reason for the need for our study documents along with her complete introduction, and I will respond to her via email if I deem it appropriate.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Golshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan,roohani street,blook131,third floor</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838677</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>sh.golshani@edu.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shaghayegh Golshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan,roohani street,blook131,third floor</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838677</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>sh.golshani@edu.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Two similar teeth in one person need to be extracted</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The crowns of the teeth that need to be extracted have decay on the buccal surface</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: recipient of dental varnish reinforced with nano-bioactive glass containing strontium and cobalt on the buccal surface of premolar teeth. Both premolar teeth in the intervention and control groups were extracted after 4 weeks</i_keyword>
      <i_keyword>Control group: Control group: without receiving varnish on the premolar tooth, which receives distilled water for blinding. Both premolar teeth in the intervention and control groups were extracted after 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antimicrobial properties of teeth. Timepoint: 4 weeks. Method of measurement: Counting the number of mutans bacteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number which is obtained by diagnodent pen. Timepoint: The effect of varnish on the number obtained from the Diagnodent pen at the beginning of the study and after 4 weeks. Method of measurement: Diagnodent laser pen.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-21</approval_date>
        <contact_name>Ethics Committee of Hamشdan University of Medical Sciences</contact_name>
        <contact_address>Hamedan, Chaharrah-e-Khoresh, Shahid Fahmideh St., in front of Mardom Park, Faculty of Dentistry, Children's Department Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
