<?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>IRCT20210113050025N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-21</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>ٍٍEffect of  Hypericum Perforatum extract on tissue healing.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of  Hypericum Perforatum extract on soft tissue healing of tooth extraction socket.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants are not informed in which direction the intervention will take place.
The socket one side is randomly selected as the test area and the opposite side as the control. Be. If the selected number is even, the right side is defined as the intervention and the left side as the control, and if it is odd, the left side is defined as the intervention and the right side as the control.
The dentist who puts herbal gel in the socket identifies the intervention site with a color code in the checklist.
The researcher who examines the tooth socket in follow up sessions evaluate the healing process without knowing the meaning of the code.</study_design>
      <phase>3</phase>
      <hc_freetext>postextraction socket healing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  After achieving adequate anesthesia and tooth extraction the dentist will place 2ml of  5% gel containing Hypericum Perforatum extract with the use of a syringe in the intervention side socket and then he will put a piece of gauze moistened with normal saline solution on it and ask the patient to keep the gauze piece in place for 45 min. Intervention 2: Control group: After rinsing gently with normal saline,a piece of gauze moistened with normal saline solution (NSS) will be placed on the socket wound, and the patient is asked to hold the gauze in place for 45 minutes.</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:
All data is from the proposal, raw data and project reports

When:
Data is available from the legal system six months after publication for two years

To whom:
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.

Conditions:
For legal issues and the need to use data in future studies

Where to obtain:
Faranak Shafiei, Zahra Haghigat Pasand, Masoud Moradi

How to obtain:
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Haghighatpasand Astaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Kurdistan University of medical Sciences, Pasdaran Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617713446</zip>
        <telephone>+98 87 3366 4648</telephone>
        <email>sogand.haqiqat76@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faranak Shafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Densitary Faculty, Kurdistan University of medical Sciences,Pasdaran Blvd,</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617713446</zip>
        <telephone>+98 87 3366 4648</telephone>
        <email>faranakshafiee@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People 18 to 30 years old
bilateral maxillary premolars extraction for orthodontic reasons</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Breastfeeding
Traumatic and surgical extractions
History of  systemic diseases and allergies
Smoking
Alcohol abuse
History of taking corticosteroids, contraceptives and antidepressants
Need to take antibiotics and NSAIDs after tooth extractions
Periodontal disease, infection or any pathology at the area of the tooth indicated for extraction
Need more than one carpule to create local anesthesia
Who are not willing to participate during the follow ups</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  After achieving adequate anesthesia and tooth extraction the dentist will place 2ml of  5% gel containing Hypericum Perforatum extract with the use of a syringe in the intervention side socket and then he will put a piece of gauze moistened with normal saline solution on it and ask the patient to keep the gauze piece in place for 45 min.</i_keyword>
      <i_keyword>Control group: After rinsing gently with normal saline,a piece of gauze moistened with normal saline solution (NSS) will be placed on the socket wound, and the patient is asked to hold the gauze in place for 45 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healing score. Timepoint: Third and seventh day after tooth extraction. Method of measurement: Healing index by Landry, Turnbull and Howley.</prim_outcome>
      <prim_outcome>Wound size. Timepoint: Extraction day (baseline), third and seventh day after tooth extraction. Method of measurement: Castroviejo caliper.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain severity. Timepoint: Extraction day (baseline), third and seventh day after tooth extraction. Method of measurement: Numeric Pain Rating Scale.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-11</approval_date>
        <contact_name>Ethics committee of Kurdistan University of medical Sciences</contact_name>
        <contact_address>Pasdaran ave , Kurdistan University of medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
