<?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>IRCT20200531047611N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of  clinical efficacy of primary anterior restoration with two different types of post systems in severely damaged  teeth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  clinical efficacy of primary anterior restoration with two different types of post systems with reconstruction of severely damaged  teeth in3-5 years old children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48790</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The teeth of each patient were randomly selected to be repaired through a composite post or customized glass fiber post. The randomization method was that the side that started first was determined by a coin, and then it was decided on the treatment when opening a closed envelope, Blinding description: The consequence assessors were different from the therapist, and the assessor was not aware of the information of patients and the type of treatment taken on the teeth. The patient was not also informed of the type of treatment on the teeth.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dental caries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann &amp; Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was used in accordance with factory instructions. So that, 3 mm of it remained inside the canal, and the remaining (2mm) was placed outside of the canal as a core. Some 5 mm strip-shaped fibers were packed inside the canal along with a thin layer of resinous cement (Bisco-DOU-LINK UNIVERSAL, USA), until the space inside the channel was completely filled. After that, it was cured for 20 seconds by a dental light curing device with a power of 800 mw / cm2. To rebuild the crown, the enamel was etched for 15 seconds by 35% phosphoric acid (Scotchbond ™ Etchant, 3M ESPE, MN, USA). Bonding was applied in the same way as addressed above and after 10 seconds of curing, and the crown was restored by microhybrid composite (Bisco-AELITE ALL / PURPOSE BODY, USA) and the method of incremental. Intervention 2: Control group:All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann &amp; Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.In the following, bonding was applied by the self-etching method based on the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. The composite was then utilized as a post (as a control group). In this group, after applying the bonding in the same mentioned method and its curing for 20-30 seconds (based on factory instructions), one layer of flow composites (Bisco- AELITEFLO /AELITEFLO LV,USA) was placed inside the canal and was layered up to a height of 3 mm. The crown rebuild was performed by microhybrid composite.</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:
information form No.1 &amp; 2
potential data can be shared after being unrecognizable

When:
access is opened 6 months after publication

To whom:
researchers occupied in scientific and higher education facilities

Conditions:
for systematic review with permission of the researcher

Where to obtain:
Faezeh Abedi
09132040583
faezehabedi72@yahoo.com

How to obtain:
through E-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No18, Noshad dead-end, Gordafrid Ave, North Kargar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411958574</zip>
        <telephone>+98 31 3366 2188</telephone>
        <email>faezehabedi72@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Askarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.81,West Jamalli Alley,Vafamanesh Ave.,Heravi square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1668754518</zip>
        <telephone>+98 21987486</telephone>
        <email>nahidaskarizadeh@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cooperator on the basis Frankel I and II
Mentally and physically healthy children who were not involved in systemic disease
The maxillary anterior deciduous tooth which its pulp was involved
The maxillary anterior deciduous tooth with similar caries on both sides
A tooth with more than two-thirds of its root length without physiological or pathological analysis (internal and external)
At least 1 mm of the supragingival structure without caries</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of trauma
Existence of destructive oral habits
Teeth with hypoplasia
Children involved in poor oral hygiene</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries on smooth surface penetrating into pulp</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>Intervention group: All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann &amp; Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was used in accordance with factory instructions. So that, 3 mm of it remained inside the canal, and the remaining (2mm) was placed outside of the canal as a core. Some 5 mm strip-shaped fibers were packed inside the canal along with a thin layer of resinous cement (Bisco-DOU-LINK UNIVERSAL, USA), until the space inside the channel was completely filled. After that, it was cured for 20 seconds by a dental light curing device with a power of 800 mw / cm2. To rebuild the crown, the enamel was etched for 15 seconds by 35% phosphoric acid (Scotchbond ™ Etchant, 3M ESPE, MN, USA). Bonding was applied in the same way as addressed above and after 10 seconds of curing, and the crown was restored by microhybrid composite (Bisco-AELITE ALL / PURPOSE BODY, USA) and the method of incremental.</i_keyword>
      <i_keyword>Control group:All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann &amp; Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.In the following, bonding was applied by the self-etching method based on the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. The composite was then utilized as a post (as a control group). In this group, after applying the bonding in the same mentioned method and its curing for 20-30 seconds (based on factory instructions), one layer of flow composites (Bisco- AELITEFLO /AELITEFLO LV,USA) was placed inside the canal and was layered up to a height of 3 mm. The crown rebuild was performed by microhybrid composite</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surface texture. Timepoint: 3,6 months after treatment. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Marginal integrity. Timepoint: 3,6 months after treatment. Method of measurement: Examination with dental explorer.</prim_outcome>
      <prim_outcome>Marginal discoloration. Timepoint: 3,6 months after treatment. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Secondary caries. Timepoint: 3,6 months after treatment. Method of measurement: Radiography.</prim_outcome>
      <prim_outcome>Restoration failure. Timepoint: 3,6 months after treatment. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Retention. Timepoint: 3,6 months after treatment. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Gingival health. Timepoint: 3,6 months after treatment. Method of measurement: Probing.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-27</approval_date>
        <contact_name>Ethics committee of Islamic Azad university of medical sciences,dental school</contact_name>
        <contact_address>No.9, Neyestan 9th alley, Pasdaran Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
