<?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>IRCT20180630040290N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-30</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the Effects of Echium Amoenum Tea on Pain Control after Clinical Crown lengthening Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the Effects of Echium Amoenum Tea on Pain Control after Clinical Crown lengthening Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40649</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling Method is randomly among Individuals referring to the Periodontics Department of Tabriz Dental faculty. The randomization Method is simple and the unit is individual, our tool for randomization is the randomized Number Chart. Furthermore, the Allocation of Echium Amoenum tea or placebo to patients is done randomly. To do this, the types of treatments are identified with code A (Echium Amoenum tea) and B (placebo) and then they will be placed in a Box and stirred.  Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient.  None of the Patients will be informed about another Patient's treatment, Blinding description: Present Study is conducted in double-blinded fashion. Both Echium Amoenum tea and placebo will be in similar envelopes ( the same shape, size and color ).Sampling Method is randomly among Individuals referring to the Periodontics Department of Tabriz Dental faculty. The randomization Method is simple and the unit is individual, our tool for randomization is the randomized Number Chart. Furthermore, the Allocation of Echium Amoenum tea or placebo to patients is done randomly. To do this, the types of treatments are identified with code A (Echium Amoenum tea) and B (placebo) and then they will be placed in a Box and stirred.  Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient.  None of the Patients will be informed about another Patient's treatment.The placebo group is treated in the same way as the intervention group, but instead of the Echium Amoenum tea, they will use ordinary water as a placebo. Contributors are unaware of the many types of treatment in the study and they are not aware of the other participants. The evaluator is also unaware of the type of treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Decrease the crown length of the tooth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use a dose of Echium Amoenum Tea. Intervention 2: Control group: The placebo group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use water as placebo.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having conscious awareness
Patients who are candidates for surgery can increase the length of the crown of the tooth (in the posterior maxilla).
ages from 20 to 65 years old
Patients who are physically and mentally healthy
Patients with moderate to severe periodontitis at the same depth of envelope</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic or mental illness
Alcoholism or any psychoactive substance
Sensitization known to be NSAID, caffeine or acetaminophen
Having any bleeding disorder
Patients at risk for any post-surgical infection
Patients with liver problems
Patients with a heart  and  blood pressure problems
Persons with mental and physical disabilities (persons who do not have the competence to satisfy their personal satisfaction and complete the questionnaires)
Patients who use of Echium Amoenum Tea are risky for them
Patients who need to increase the dose of sedative or injectable forms of sedative
Patients with no needs for bone surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Loss of teeth due to accident, extraction or local periodontal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use a dose of Echium Amoenum Tea.</i_keyword>
      <i_keyword>Control group: The placebo group 24 hours before surgery every 12 hours once , and one hour before the start of surgery, will use water as placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Extent of pain in the operated part. Timepoint: َAfter 30 minutes, 1 and 3 hours after the operation , 1 and 2 and 3 days after the operation. Method of measurement: En 30 minutes, 1 and 3 hours after the operation by VAS(Visual Analogue Scale) , after 1 and 2 and 3 days by VRS(Verbal Rating Scale).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-01</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
