<?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>IRCT20180521039763N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-15</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comperative clinical evaluation of resin based pit and fissure sealant and self adhering flowable composite</public_title>
      <acronym></acronym>
      <scientific_title>Comperative clinical evaluation of resin based pit and fissure sealant and self adhering flowable composite</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54418</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: Participants in this clinical trial are not aware of the type of material used to treat each of their teeth, and the statistics consultant is not aware of the type of treatment performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dental caries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the surface of the first permanent lower right molar in each patient is cleaned of debris and plaque by a rotating brush, and after rinsing and drying the dental surfaces and examining the occlusion by articulating paper, it is isolated by a cotton roll inside the buccal lingual vestibule. Then, according to the manufacturer instructions  of the self-adhesive flowable composite (Vertise flow) based on the no need for acid etching and bonding process before placing the composite, after drying the teeth, the self-adhesive composite (with maximum thickness of 0.5 mm) by using a microbrush is  placed on the grooves of the teeth for 20 seconds and then cured for 40 seconds using a light curing device (Coltene AG, Altstatten, Coltolux Switzerland). Intervention 2: Intervention group:  First, the surface of the first permanent lower left molar in each patient was cleaned of debris and plaque with a rotating brush, and after washing and drying the tooth surfaces and examining the occlusion by articulator paper, it was isolated by a cotton roll inside the buccal and lingual vestibule. Then pits and fissures of the occlusal surfaces of the molar are etched with 37% phosphoric acid (Brasil / FGM) for 20 seconds and then rinsed with water for 15 seconds and dried by gentle air flow. If the etching surfaces are contaminated with saliva, the tooth surface will be etched again for 10 seconds. Then, two layers of Adper bonding are applied and a gentle stream of air is used for five seconds to evaporate the solvent, and then the curing is performed with a light curing device for 20 seconds, after that the resin-based pit and fissure sealant is placed on the bonding. After ensuring the absence of voids by gently moving the dental probe over the pit and fissures, the sealant is cured for 40 seconds.</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:
Only a portion of the data is shared, such as the original outcome information

When:
Start the access period, 6 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
For researchers

Where to obtain:
reyhane9495@gmail.com

How to obtain:
1 month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhane Aftabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, adjacent to Shafa Hospital, Shafa Ave.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>00883432119021</telephone>
        <email>reyhane9495@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reyhane Aftabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, adjacent to Shafa Hospital, Shafa Ave.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>reyhane9495@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 6 to 12 years
Permanent first molars of the mandible with no cl I, cl II and cl v caries lesion
Possibility of isolation with cotton roll
Fully erupted permanent molars
Absence of oral habits such as clenching, bruxism and heavy occlusion in the studied teeth
Absence of previous dental treatment on the first permanent mandibular molars
Molars with deep pit and fissures with the susceptibility of future caries
Absence of interfering medical systemic problems in the study
Not consuming any drugs that affect saliva flow</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unablity of the operator for proper isolation
Uncooperative child
Permanent first mandibular molars with dentin caries lesions
Existence of opaque-gray shadows on the bottom of the grooves
Existence of grooves and fissures with brown-gray discoloration branching from the center of the groove to around of the groove or pit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries</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: First, the surface of the first permanent lower right molar in each patient is cleaned of debris and plaque by a rotating brush, and after rinsing and drying the dental surfaces and examining the occlusion by articulating paper, it is isolated by a cotton roll inside the buccal lingual vestibule. Then, according to the manufacturer instructions  of the self-adhesive flowable composite (Vertise flow) based on the no need for acid etching and bonding process before placing the composite, after drying the teeth, the self-adhesive composite (with maximum thickness of 0.5 mm) by using a microbrush is  placed on the grooves of the teeth for 20 seconds and then cured for 40 seconds using a light curing device (Coltene AG, Altstatten, Coltolux Switzerland).</i_keyword>
      <i_keyword>Intervention group:  First, the surface of the first permanent lower left molar in each patient was cleaned of debris and plaque with a rotating brush, and after washing and drying the tooth surfaces and examining the occlusion by articulator paper, it was isolated by a cotton roll inside the buccal and lingual vestibule. Then pits and fissures of the occlusal surfaces of the molar are etched with 37% phosphoric acid (Brasil / FGM) for 20 seconds and then rinsed with water for 15 seconds and dried by gentle air flow. If the etching surfaces are contaminated with saliva, the tooth surface will be etched again for 10 seconds. Then, two layers of Adper bonding are applied and a gentle stream of air is used for five seconds to evaporate the solvent, and then the curing is performed with a light curing device for 20 seconds, after that the resin-based pit and fissure sealant is placed on the bonding. After ensuring the absence of voids by gently moving the dental probe over the pit and fissures, the sealant is cured for 40 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-adhesive composite retention and incidence of secondry caries. Timepoint: 3, 6, 12 months. Method of measurement: Clinical examination with a dental probe and a dental mirror.</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>2021-01-21</approval_date>
        <contact_name>Ethics committee of Kerman university of medical sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Shafa crossroad, Jomhuri Eslami Blvd. Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
