<?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>IRCT20200831048565N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-21</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is simple randomization (coin tossing) and people are divided into two groups using coin tossing method. If after throwing it was on the coin line, the person is in the first group (tooth restoration with ssc) and if it was on the coin valve in the second group (tooth restoration with composite) and the coin is thrown until the specified sample volume is reached, Blinding description: The data were provided anonymously and in coded groups to the researcher, outcome assessor, data analyzer, and data monitoring committee.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dental caries.</hc_freetext>
      <i_freetext>Intervention 1: SSC restoration (control group): - Occlusion check - Separation of adjacent teeth with wooden wedge (enamel, Iran) - Proximal surfaces are cut with strile turbine bur (Tizkavan, Tehran, Iran) with rapid rotation and water spray. Contact with adjacent teeth was cut. - Cutting the cusps and occlusal surface was done using a strile turbine bur machine (Tizkavan, Tehran, Iran) with a high speed and water spray. A distance of 1 mm was created with the opposite tooth. - Any sharpness was removed using a strile turbine bur machine (Tizkavan, Tehran, Iran). Contour and crimp as needed. - SSC with glass ionomer (GC-Fuji l) was cemented. Intervention 2: Occlusion check - complete removal of caries and removal of unsupported enamel using strile turbine fissure bur (Tizkavan, Tehran, Iran) using water spray. - Application of a layer of optical glass ionomer cement with a thickness of 1 mm on the base Reinforced eugenol zinc oxide (Kemdent, England) was placed to prevent interference of eugenol with the resin polymerization reaction and then cured by a calibrated light curing device for 40 seconds.Adapting the brace to the tooth and placing the wedge (Mina, Iran) to accurately match the brace to the tooth and holding the brace in place - the cavity was etched for 37 seconds using 37% phosphoric acid gel (Kimia, Iran). The acid was then washed with water powder. The enamel part of the cavity was dried with air powder and the dentin part of the cavity was dried with a cotton ball. It was then cured by a calibrated light curing machine for 20 seconds. - Flow composite (VOCO-X-tra base, USA) was placed in layers with a maximum thickness of 4 mm at the bottom of the cavity and each layer for at least 40 seconds. It was cured using a calibrated light curing device.-A composite layer (VOCO-X-TRF FILL, USA) with a maximum thickness of 4 mm was placed on the occlusal surface and cured for at least 40 seconds using a calibrated light curing device.-Occlusion after removing the tail rubber with The use of an articulation paper was checked and, if necessary, adjusted with a polishing bur (American Sharpener).</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 Non-disclosure of patient secrets</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raziyeh Shojaeipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school,  Shafa Ave,  Jomhoori Blvd,  Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>fateme.moslemi1991@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Raziyeh Shojaeipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school,  Shafa Ave,  Jomhoori Blvd,  Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>003432119021</telephone>
        <email>fateme.moslemi1991@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Physical and mental health
2- Age 4 to 6 years old
3- Frankl 3 or 4 level of cooperation
4- No history of dental restoration treatment
5- Having at least one deciduous molars with these conditions: a) According to radiography and signs and symptoms Clinical dental clinics. b) The teeth had caries of equal size and multilevel.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Lack of general health
2- Lack of cooperation for treatment
3- Having a history of restoration of deciduous molar teeth
4- Nonvital deciduous molar teeth
5- Tooth crowns were irreparable</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>SSC restoration (control group): - Occlusion check - Separation of adjacent teeth with wooden wedge (enamel, Iran) - Proximal surfaces are cut with strile turbine bur (Tizkavan, Tehran, Iran) with rapid rotation and water spray. Contact with adjacent teeth was cut. - Cutting the cusps and occlusal surface was done using a strile turbine bur machine (Tizkavan, Tehran, Iran) with a high speed and water spray. A distance of 1 mm was created with the opposite tooth. - Any sharpness was removed using a strile turbine bur machine (Tizkavan, Tehran, Iran). Contour and crimp as needed. - SSC with glass ionomer (GC-Fuji l) was cemented.</i_keyword>
      <i_keyword>Occlusion check - complete removal of caries and removal of unsupported enamel using strile turbine fissure bur (Tizkavan, Tehran, Iran) using water spray. - Application of a layer of optical glass ionomer cement with a thickness of 1 mm on the base Reinforced eugenol zinc oxide (Kemdent, England) was placed to prevent interference of eugenol with the resin polymerization reaction and then cured by a calibrated light curing device for 40 seconds.Adapting the brace to the tooth and placing the wedge (Mina, Iran) to accurately match the brace to the tooth and holding the brace in place - the cavity was etched for 37 seconds using 37% phosphoric acid gel (Kimia, Iran). The acid was then washed with water powder. The enamel part of the cavity was dried with air powder and the dentin part of the cavity was dried with a cotton ball. It was then cured by a calibrated light curing machine for 20 seconds. - Flow composite (VOCO-X-tra base, USA) was placed in layers with a maximum thickness of 4 mm at the bottom of the cavity and each layer for at least 40 seconds. It was cured using a calibrated light curing device.-A composite layer (VOCO-X-TRF FILL, USA) with a maximum thickness of 4 mm was placed on the occlusal surface and cured for at least 40 seconds using a calibrated light curing device.-Occlusion after removing the tail rubber with The use of an articulation paper was checked and, if necessary, adjusted with a polishing bur (American Sharpener).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of color restoration on the quality of daily life of the child. Timepoint: Immediately after repair, 3 months, 6 months, 12 months. Method of measurement: Designed questionnaire.</prim_outcome>
      <prim_outcome>Success rate of composite restoration and SSC. Timepoint: Immediately after repair, 3 months, 6 months, 12 months. Method of measurement: Clinical and radiographic examination.</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>Kerman 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 committe of kerman university of medical sciences</contact_name>
        <contact_address>Kerman dental school,Shafa Ave ,Jomhoori Blvd،Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
