<?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>IRCT2016020420004N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-23</date_registration>
      <primary_sponsor>Vice challenger of research,Islamic Azad Dental University of Tehran</primary_sponsor>
      <public_title>Evaluation of Pro root-MTA and Retro root-MTA in partial pulpotomy of human dental healthy pulp</public_title>
      <acronym></acronym>
      <scientific_title>Clinical, radiological and histological evaluation of Pro root-MTA and Retro root-MTA in partial pulpotomy of human dental healthy pulp</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Vital pulp therapy.</hc_freetext>
      <i_freetext>Intervention 1: Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&amp;W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sites.   &#13;
In group 1 the pulps and the surrounding dentins will be capped with Retro-MTA as an interventive group.Reto-MTA  is a hydraulic bioceramic material for repair and vital pulp therapy.  Retro-MTA is powder consisting of fine,hydrophilic particles that set in the presence of water and form a strong  impermeable barrier.it contains hydraulic calcium zirconia complex as a contrast media.setting time is 150 seconds.it has no discoloration even in the blood contamination.it has no toxicity to cells in 48 hours.this means it is a ideal substance for vital pulp therapy.fast setting,no discoloration,no heavy metal,no cell toxicity,good handeling properties and economic price are some of sultaible properties of Retro-MTA.in vivo condition Ph is up to 12/5and down to 7.8-8 in 4 weeks.Ex vivo study shows it has the high potential for biomineralization. هی 0/3 gram Retro root-MTA powder with 3 drops of  water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears.         &#13;
 The teeth will be provisionally restored with glass ionomer cement (Ketac Molar; 3M ESPE, Seefeld, Germany).&#13;
2 months later, patients  will return back and after  clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All the clinical procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Islamic Azad  Dental university of Tehran. Intervention 2: Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&amp;W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sitesProRoot MTA(Dentsply-USA) is a water-based material which uses for apexification, repairing root perforations and As a pulp capping material.It sets in the presence of moisture. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.In group II exposed pulps and the surrounding dentins will be capped with Retro-MTA.0/3 gram Retro root-MTA powder with 3 drops of  water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears.  2 months later, patients  will return back and after  clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Dental School.</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>Hengameh Bakhtiar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit2, No10, Gandi st, 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>Hengameh Bakhtiar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit2, No10, Gandi st, 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: age between18-32 years old; erupted third molar; closed apex; caries free; normal sign to vitality tests. Exclusion criteria: external or internal resorptin; peri apical lesion.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>32 years</agemax>
      <gender>Both</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&amp;W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sites.   &#13;
In group 1 the pulps and the surrounding dentins will be capped with Retro-MTA as an interventive group.Reto-MTA  is a hydraulic bioceramic material for repair and vital pulp therapy.  Retro-MTA is powder consisting of fine,hydrophilic particles that set in the presence of water and form a strong  impermeable barrier.it contains hydraulic calcium zirconia complex as a contrast media.setting time is 150 seconds.it has no discoloration even in the blood contamination.it has no toxicity to cells in 48 hours.this means it is a ideal substance for vital pulp therapy.fast setting,no discoloration,no heavy metal,no cell toxicity,good handeling properties and economic price are some of sultaible properties of Retro-MTA.in vivo condition Ph is up to 12/5and down to 7.8-8 in 4 weeks.Ex vivo study shows it has the high potential for biomineralization. هی 0/3 gram Retro root-MTA powder with 3 drops of  water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears.         &#13;
 The teeth will be provisionally restored with glass ionomer cement (Ketac Molar; 3M ESPE, Seefeld, Germany).&#13;
2 months later, patients  will return back and after  clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All the clinical procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Islamic Azad  Dental university of Tehran.</i_keyword>
      <i_keyword>Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&amp;W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sitesProRoot MTA(Dentsply-USA) is a water-based material which uses for apexification, repairing root perforations and As a pulp capping material.It sets in the presence of moisture. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.In group II exposed pulps and the surrounding dentins will be capped with Retro-MTA.0/3 gram Retro root-MTA powder with 3 drops of  water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears.  2 months later, patients  will return back and after  clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Dental School.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulp health(Post Operative sensitivity and pain ). Timepoint: After treatment,1 week later and before extraction. Method of measurement: Vitality test,Cold test and EPT.</prim_outcome>
      <prim_outcome>Signs of periapical pathology. Timepoint: Radiographs are taken before intervention and extraction. Method of measurement: PA Radiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dentin barrier formation. Timepoint: Eight weeks after beginning treatment. Method of measurement: Histological examination after 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>Vice challenger of research,Islamic Azad Dental University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-14</approval_date>
        <contact_name>Moral Committee of  Islamic Azad Dental university of Tehran</contact_name>
        <contact_address>Azad Dental School, #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>
