<?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>IRCT20221101056372N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Antibacterial efficacy of non-thermal atmospheric pressure plasma on dental caries</public_title>
      <acronym></acronym>
      <scientific_title>Antibacterial efficacy of non-thermal atmospheric pressure plasma against Streptococcus mutans and lactobacillus acidophilus of carious dentin: a clinical study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dental caries.</hc_freetext>
      <i_freetext>The studied population is people who have referred to the restorative department of Tehran Dental School for teeth restoration. After explaining the procedure to the patient and obtaining written consent from them, the patients are tested. The teeth that have cavities and clinical symptoms of spontaneous pain, irreversible pulpitis and deep decay are selected for study. The caries of the surface area (baseline samples) is removed with the help of a small size excavator, 2 mm long, 1 mm wide and 0.5 mm deep, equal to the volume of the excavator, and placed in an Ependorf tube containing a reduced transition medium based on thioglycollate without glucose. Then cold helium plasma is applied to the decay cavity by a plasma device containing helium gas (purity 99.999%) with a nozzle diameter of 3 mm, voltage of 10 kV, frequency of 6 kHz at a distance of 1 cm from the decay cavity for one minute and another sterile excavator of another sample is prepared in the vicinity and at the same level as the baseline sample, equal to the volume of the small size exciter, and is placed in an Ependorf tube containing a reduced transfer medium based on thioglycolate without glucose.Before treatment and after treatment, as much as possible, the patient's samples are collected in equal amounts in Ependorf tubes containing a reduced thioglycollate-based transfer medium without glucose. The samples are transferred to the microbiology research laboratory of Tehran University of Medical Sciences at ambient temperature within 24 hours. Mitis Salivarius agar containing valinomycin (MS-MUTV) and De Man Rogosa Sharpe agar containing maltose (MRSM) are used as selective and differential media for tracking and counting (determination of CFU/mL) S. mutans and L. acidophilus, respectively. to be After inoculation, the media are incubated for 48 hours in capnophilic conditions created by Gazpak in jars at 37°C. Then the CFU/mL of the studied bacteria will be calculated. Finally, the obtained numbers will be subjected to statistical analysis. The relationship between plasma and its effect on the number of bacteria on the tested samples is investigated. The significance level in this study is considered 0.05 (P value = 0.05)..</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:
Raw data and analysis of bacterial counts are available for publication. Other data cannot be published.e

When:
access to data from 2024

To whom:
for researchers working in academic institutions

Conditions:
For researchers, the CFU data of bacteria samples and analysis will be available.

Where to obtain:
mandana karimi
Mandanakarimi1374@yahoo.com

How to obtain:
request to the researcher of thesis and determine clearly the purpose

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mandana karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 10, 34th street, Gisha</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1448985464</zip>
        <telephone>+98 21 8611 2910</telephone>
        <email>Mandanakarimi1374@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mandana karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 10, 34th street, Gisha</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1448985464</zip>
        <telephone>+98 21 8611 2910</telephone>
        <email>mandanakarimi1374@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>dental cavitaed caries</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>systemic diseases
endodontic dental pain</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 - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The studied population is people who have referred to the restorative department of Tehran Dental School for teeth restoration. After explaining the procedure to the patient and obtaining written consent from them, the patients are tested. The teeth that have cavities and clinical symptoms of spontaneous pain, irreversible pulpitis and deep decay are selected for study. The caries of the surface area (baseline samples) is removed with the help of a small size excavator, 2 mm long, 1 mm wide and 0.5 mm deep, equal to the volume of the excavator, and placed in an Ependorf tube containing a reduced transition medium based on thioglycollate without glucose. Then cold helium plasma is applied to the decay cavity by a plasma device containing helium gas (purity 99.999%) with a nozzle diameter of 3 mm, voltage of 10 kV, frequency of 6 kHz at a distance of 1 cm from the decay cavity for one minute and another sterile excavator of another sample is prepared in the vicinity and at the same level as the baseline sample, equal to the volume of the small size exciter, and is placed in an Ependorf tube containing a reduced transfer medium based on thioglycolate without glucose.Before treatment and after treatment, as much as possible, the patient's samples are collected in equal amounts in Ependorf tubes containing a reduced thioglycollate-based transfer medium without glucose. The samples are transferred to the microbiology research laboratory of Tehran University of Medical Sciences at ambient temperature within 24 hours. Mitis Salivarius agar containing valinomycin (MS-MUTV) and De Man Rogosa Sharpe agar containing maltose (MRSM) are used as selective and differential media for tracking and counting (determination of CFU/mL) S. mutans and L. acidophilus, respectively. to be After inoculation, the media are incubated for 48 hours in capnophilic conditions created by Gazpak in jars at 37°C. Then the CFU/mL of the studied bacteria will be calculated. Finally, the obtained numbers will be subjected to statistical analysis. The relationship between plasma and its effect on the number of bacteria on the tested samples is investigated. The significance level in this study is considered 0.05 (P value = 0.05).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The CFU of dental caries bacteria. Timepoint: before and after. Method of measurement: Mitis Salivarius agar containing valinomycin and De Man Rogosa Sharpe agar containing maltose are used as selective and differential media for the detection and counting (determination of CFU/mL) of S. mutans and L. acidophilus, respectively.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-30</approval_date>
        <contact_name>dentistry school, Tehran university of medical science</contact_name>
        <contact_address>no 10, 34th street, Gisha Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
