<?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>IRCT2016082229476N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-20</date_registration>
      <primary_sponsor>Vice Chancellery of Research Affairs</primary_sponsor>
      <public_title>effectiveness of Fissure-Sealant therapy in decreasing the level of dental caries in 6-12 years old school children</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of community based Fissure-Sealant therapy in decreasing the level of dental caries in 6-12 years old school children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>185</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23678</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single 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 group1: The intervention was Fissure sealant treatment carried out by the senior dental students. It was provided as a part of "field program” of Department of Oral Public Health in 2015. Teeth of contrary two quadrants (36–46 and/or 16–26 teeth) were randomly allocated in either the intervention or the control groups. Teeth with deep pit and fissures either healthy or at early stages of enamel decay (ICDAS 0-2) were included in the study and regarding the six codes of ICDAS dental caries, severity for all full-erupted first permanent molars was recorded at baseline.  The treatment process included cleaning teeth with low-speed tooth brushing without prophylaxis paste, isolation with cotton rolls and suction, etching with Ultra etch gel (35% phosphoric acid, ultradent Products Inc, USA) for 30 seconds. After thoroughly water rinsing and air drying, applying the bonding agent by Single Bond 2(3M ESPE, USA) and curing, resin-based sealant was applied (Prime-Dent®. Prime Dental manufacturing Inc.3735 W. Belmont Ave. Chicago) to the pit and fissures on the occlusal and buccal surfaces. Using curing light (device LED light cure Woodpecker Medical Instrument Co, China 400-600 mw/cm2) all coated surfaces exposed for 45 seconds. After setting the sealant, teeth were checked by supervisors for retention, air bubbles and occlusal adjustments. If necessary, the processes were repeated. Intervention 2: Control group: The teeth in the contrary quadrant received no treatment.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Imaneh Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib ST</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5594</telephone>
        <email>asgari_i@yahoo.com</email>
        <affiliation>Oral Public Health Department, Dental School, Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Bahareh Tahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib st, Isfahan University of Medical Sciences</address>
        <city>Iafahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5594</telephone>
        <email>tahani@dnt.mui.ac.irtahani_b@yahoo.com</email>
        <affiliation>Oral Public Health Department, IsfahanUniversity of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: all primary school students (1st and 2nd grade) between the ages of 8 to 10-years-old;  low socio-economic rural areas of Golpayegan city of Isfahan province; permanent residents; having at least two sound teeth in two contrary quadrants; teeth with deep sound pit and fissures or primary dental caries (ICDAS 0-2) &#13;
Exclusion Criteria: no patient cooperation; parents not being eager to participate</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.0–K02.</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 group1: The intervention was Fissure sealant treatment carried out by the senior dental students. It was provided as a part of "field program” of Department of Oral Public Health in 2015. Teeth of contrary two quadrants (36–46 and/or 16–26 teeth) were randomly allocated in either the intervention or the control groups. Teeth with deep pit and fissures either healthy or at early stages of enamel decay (ICDAS 0-2) were included in the study and regarding the six codes of ICDAS dental caries, severity for all full-erupted first permanent molars was recorded at baseline.  The treatment process included cleaning teeth with low-speed tooth brushing without prophylaxis paste, isolation with cotton rolls and suction, etching with Ultra etch gel (35% phosphoric acid, ultradent Products Inc, USA) for 30 seconds. After thoroughly water rinsing and air drying, applying the bonding agent by Single Bond 2(3M ESPE, USA) and curing, resin-based sealant was applied (Prime-Dent®. Prime Dental manufacturing Inc.3735 W. Belmont Ave. Chicago) to the pit and fissures on the occlusal and buccal surfaces. Using curing light (device LED light cure Woodpecker Medical Instrument Co, China 400-600 mw/cm2) all coated surfaces exposed for 45 seconds. After setting the sealant, teeth were checked by supervisors for retention, air bubbles and occlusal adjustments. If necessary, the processes were repeated</i_keyword>
      <i_keyword>Control group: The teeth in the contrary quadrant received no treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sealant retention. Timepoint: exactly after treatment, one year after treatment. Method of measurement: Oral Examination.</prim_outcome>
      <prim_outcome>Caries Incidence. Timepoint: before the treatment, One year after the treatment. Method of measurement: Oral Examination and ICDAS recording.</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>Vice Chancellery of Research Affairs</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezarjarib ST, Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
