<?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>IRCT2016041120004N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-25</date_registration>
      <primary_sponsor>Islamic azad dental university</primary_sponsor>
      <public_title>Long term effects of Theracal in partial pulpotomy of human dental pulp</public_title>
      <acronym></acronym>
      <scientific_title>Clinical,radiological,histological long term effects of Theracal in partial pulpotomy of human dental pulp</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17758</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vital pulp therapy.</hc_freetext>
      <i_freetext>Before the operative protocol, the tooth will be radiologically examined to exclude the presence of caries or periapical pathology. Thermal testing and electric sensitivity testing will perform to assess pulp vitality. Before cavity preparation, the tooth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Septodont, Saint Maur des Fosses, France) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond bur at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide bur (4 1.2 mm) under sterile saline cooling. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure site and will be capped with Theracal according to the manufacturer’s recommendations. Theracal is a calcium silicate resin based material that cures in 20 seconds and is used for direct and indirect pulpcapping. It contains approximately 45% wt mineral material, 10% wt radiopaque component, 5% wt hydrophilic thickening agent and approximately 45% resin. The patent stated that the resin consists of a hydrophobic component such as urethane dimethacrylate, bisphenol A-glycidyl methacrylate, triethylene glycol dimethacrylate and a hydrophilic component such as hydroxyethymethacrylate and polyethylene glycol dimethlacrylate. After placing a 2 mm layer of Theracal paste and polymerization for 20 s, the teeth will be provisionally restored with glass ionomer cement (GC).After a year after radio graphical and clinical examinations  the tooth will be extracted and will be sent to a talented pathologist..</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 Hengameh Bakhtiar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>#10 Neyestan, Pasdaran Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2705</telephone>
        <email>H_bakhtiar@dentaliau.ac.ir</email>
        <affiliation>Islamic azad dental university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hengameh Bakhtiar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>#10 Neyestan, Pasdaran Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2705</telephone>
        <email>H_bakhtiar@dentaliau.ac.ir</email>
        <affiliation>Islamic azad dental university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are: age (18-32), erupted third molar, closed apex, caries free, normal signs to vitality tests and exclusion criteria are: external or internal resorption and periapical lesion. The main outcome measure is pulp health and dentine barrier formation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>32 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IA49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Infection disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Before the operative protocol, the tooth will be radiologically examined to exclude the presence of caries or periapical pathology. Thermal testing and electric sensitivity testing will perform to assess pulp vitality. Before cavity preparation, the tooth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Septodont, Saint Maur des Fosses, France) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond bur at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide bur (4 1.2 mm) under sterile saline cooling. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure site and will be capped with Theracal according to the manufacturer’s recommendations. Theracal is a calcium silicate resin based material that cures in 20 seconds and is used for direct and indirect pulpcapping. It contains approximately 45% wt mineral material, 10% wt radiopaque component, 5% wt hydrophilic thickening agent and approximately 45% resin. The patent stated that the resin consists of a hydrophobic component such as urethane dimethacrylate, bisphenol A-glycidyl methacrylate, triethylene glycol dimethacrylate and a hydrophilic component such as hydroxyethymethacrylate and polyethylene glycol dimethlacrylate. After placing a 2 mm layer of Theracal paste and polymerization for 20 s, the teeth will be provisionally restored with glass ionomer cement (GC).After a year after radio graphical and clinical examinations  the tooth will be extracted and will be sent to a talented pathologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulp health(sensitivity,pain). Timepoint: Just after intervention,each month till one year. Method of measurement: Vitality test,cold test,EPT.</prim_outcome>
      <prim_outcome>Sign of preapical pathology. Timepoint: Before intervention,before extraction. Method of measurement: Periapical radiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dentin bridge formation. Timepoint: One year after invention. Method of measurement: Histologic examination after tooth extraction.</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 dental university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Moral committee of islamic azad dental university of tehran</contact_name>
        <contact_address>#10 Neyestan, Pasdaran Ave, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
