<?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>IRCT20100125003168N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-18</date_registration>
      <primary_sponsor>Reasearch Vice-Chancellor- Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The clinical comparison of two methods for pereventive resin restoration of young permanent teeth</public_title>
      <acronym></acronym>
      <scientific_title>The Clinical comparison of preventive resin restoration retention using Nano-bonding and Etch-&amp;-Rinse Adhesive systems (Conventional method)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dental caries.</hc_freetext>
      <i_freetext>Intervention 1: intervention group : 1)tooth cleaning2)remove caries3)isolation4)using Nano-bonding (G-premi Bond,GC Corpration,Tokyo,Japan) and cure for 20 seconds5)use of sealant (Clinpro-3M,USA) and cure for 20 seconds6)evaluation of occlusion and do finish and polish. Intervention 2: Control group: 1)tooth cleaning2)remove caries3)isolation4)using 37% acid etch (Etch Rite , PULPDENT Corporation , USA)for 20 seconds then , Rinse acid for 20 seconds 5)use of bonding ( single bond 2, 3M ESPE, PULPDENT Corporation ,U.S.A) and cure for 15 seconds 6)use of sealant (Clinpro-3M,USA) and cure for 20 seconds7) evaluation of occlusion and do finish and polish.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>leila Erfanparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Ave-Golgasht St.- Faculty of Dentistry-Department of Pediatric Dentistry</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>Erfanparastl@tbzmed.ac.ir</email>
        <affiliation>faculty of dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Erfanparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>Eranparastl@tbzmed.ac.ir</email>
        <affiliation>faculty of dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>group of 6-12 years of age
presence of permanent teeth of the first molar in the lower jaw on both sides with minor decay at the occlusal level
evidence of oral hygiene at home
patient collaboration and acceptance of treatment
no therapeutic treatment has been performed on the teeth previously
possibility of isolation by cotton roll and suction</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of medical illness that may interfere with treatment
drug affecting the saliva and its quality
history of allergy to any of the restorative materials
uncooperation patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k02.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>پوسیدگی های دندانی محدود به مینا</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group : 1)tooth cleaning2)remove caries3)isolation4)using Nano-bonding (G-premi Bond,GC Corpration,Tokyo,Japan) and cure for 20 seconds5)use of sealant (Clinpro-3M,USA) and cure for 20 seconds6)evaluation of occlusion and do finish and polish</i_keyword>
      <i_keyword>Control group: 1)tooth cleaning2)remove caries3)isolation4)using 37% acid etch (Etch Rite , PULPDENT Corporation , USA)for 20 seconds then , Rinse acid for 20 seconds 5)use of bonding ( single bond 2, 3M ESPE, PULPDENT Corporation ,U.S.A) and cure for 15 seconds 6)use of sealant (Clinpro-3M,USA) and cure for 20 seconds7) evaluation of occlusion and do finish and polish</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The retention of  restoration. Timepoint: 3 and 6 months. Method of measurement: exploration and observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The working time. Timepoint: 3 and 6 months. Method of measurement: exploration and observation.</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>Reasearch Vice-Chancellor- Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-29</approval_date>
        <contact_name>Research vice-chancellor,Tabriz University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave. - Golgasht St.-Tabriz University of Medical Sciences tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
