<?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>IRCT20230525058289N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-14</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>Investigation Response to Pulp Sensitivity Tests after Full Pulpotomy in Permanent Mandibular Teeth with Symptomatic Irreversible Pulpitis</public_title>
      <acronym></acronym>
      <scientific_title>Investigation Response to Pulp Sensitivity Tests after Full Pulpotomy in Permanent Mandibular Teeth with Symptomatic Irreversible Pulpitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70587</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In this study, patients with adult permanent teeth with deep or very deep occlusal/proximal caries with symptomatic irreversible pulpitis are examined..</hc_freetext>
      <i_freetext>Intervention group: In this study, two electric and cold tests were used to check the success of full pulpotomy treatment. First intervention: Electric test: In the electric pulp test, the opposite and treated tooth is removed with a cotton roll. The lip clip is placed in the corner of the patient's mouth. The tip of the electrode is covered with water-based gel and is placed between the gingival edge and the occlusal edge of the buccal surface of the mandibular molar tooth, and the contact of the electrode with the free edge of the gingiva is prevented. Finally, the patient is asked to raise his hand if he feels any emotion. The response is recorded as "Reply Received" or "No Response". The second intervention: Cold test: The cold test is performed using a cooling spray of tetrafluoroethene 2,1,1,1 and size 2 cotton, which is applied in the same position as the electric electrode on the buccal surface of the tooth. This test is performed by an endodontist for 5 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:
Data of patients after full pulpotomy in mandibular permanent teeth with symptomatic irreversible pulpitis

When:
The access period starts 1 year after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Other statistical analyzes are allowed in these data.

Where to obtain:
Send a message to the following email to receive the data
mehdiziagham@yahoo.com

How to obtain:
Send email and register request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Ziagham Ahwaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, between Nabii and Razavi, Mohammadian St, South Shariati,</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6194695761</zip>
        <telephone>+98 61 3222 8541</telephone>
        <email>mehdiziagham@yahoo.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Ziagham Ahwaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, between Nabii and Razavi, Mohammadian St, South Shariati</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6194695761</zip>
        <telephone>+98 61 3222 8541</telephone>
        <email>mehdiziagham@yahoo.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 16-35 years
adult permanent mandibular molars with deep or very deep occlusal/proximal caries with marked irreversible pulpitis
After providing complete and informative explanations about RCT treatment and complete pulpotomy, its advantages and disadvantages and success and failure rates in this type of treatment, complete pulpotomy was performed with the patient's consent. In case of treatment failure, RCT treatment was used as an alternative treatment.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Buccal and lingual caries
History of trauma and orthodontic and restorative treatments as well as specific parafunctional habits
Mandibular molar teeth with proximal occlusal caries with diagnosis of necrosis and reversible pulpitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, two electric and cold tests were used to check the success of full pulpotomy treatment. First intervention: Electric test: In the electric pulp test, the opposite and treated tooth is removed with a cotton roll. The lip clip is placed in the corner of the patient's mouth. The tip of the electrode is covered with water-based gel and is placed between the gingival edge and the occlusal edge of the buccal surface of the mandibular molar tooth, and the contact of the electrode with the free edge of the gingiva is prevented. Finally, the patient is asked to raise his hand if he feels any emotion. The response is recorded as "Reply Received" or "No Response". The second intervention: Cold test: The cold test is performed using a cooling spray of tetrafluoroethene 2,1,1,1 and size 2 cotton, which is applied in the same position as the electric electrode on the buccal surface of the tooth. This test is performed by an endodontist for 5 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success and failure of full pulpotomy. Timepoint: Success was assessed 12 months after full pulpotomy. Method of measurement: - Examination of radiographs, clinical examination (using cold and electrical tests).</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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-08</approval_date>
        <contact_name>Ethics committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Ilam University of Medical Sciences campus, Banganjab, Research Blvd, Ilam ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
