<?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>IRCT20121223011856N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-25</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Chlorhexidine on postextrction pain</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of preoperative chlorhexidine mouthwash  on pain after lower posterior teeth removal : A Randomized, Double blind Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38851</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly allocated to a treatment group based on the flip of a coin, Blinding description: 0.5 to 1 h before performing extractions, subjects will be given a dark bottle containing 15 ml of either chlorhexidine 0.2% or placebo but they have no idea of the type of the solution. we will ask the clinician to perform extractions in equal situation for all patients while he has no information about the two groups.</study_design>
      <phase>3</phase>
      <hc_freetext>postoperative pain after tooth extraction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 0.5 to 1 hours before performing extractions patient in intervention group will be given a dark bottle containing 15 ml of 0.2% chlorhexidine gluconate mouthwash (BEHSA). they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions,  patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked. Intervention 2: Control group: 0.5 to 1 hours before performing extractions patient in control group will be given a dark bottle containing 15 ml of placebo mouthwash (one liter of placebo contains 1 liter of sterile normal saline (Samen company) plus one drop of  natural edible colours made by colour splash company) . they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions,  patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Haghaighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezargarib st</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 21 8871 4273</telephone>
        <email>haghighat@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hezarjarib st</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 219025795</telephone>
        <email>haghighat@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients will be between 18 and 80 years old.
patients be healthy and not on any regular medication.
patients will not have any of pain inducing conditions such as an aching tooth at the time of the surgery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients will be excluded if they ingested any medications including oral contraceptives, analgesics and antibiotics as of 5 days prior to the operation.
smokers will be excluded</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 0.5 to 1 hours before performing extractions patient in intervention group will be given a dark bottle containing 15 ml of 0.2% chlorhexidine gluconate mouthwash (BEHSA). they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions,  patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked.</i_keyword>
      <i_keyword>Control group: 0.5 to 1 hours before performing extractions patient in control group will be given a dark bottle containing 15 ml of placebo mouthwash (one liter of placebo contains 1 liter of sterile normal saline (Samen company) plus one drop of  natural edible colours made by colour splash company) . they will rinse the solution around their mouth for two minutes. the extractions will be done by an expert clinician. After performing extractions,  patients will receive 10 pills of Acetaminophen 325 (EXIR) to be taken in case of excessive pain. patient analgesic intake and postoperative pain will be recorded by 4 telephone interviews 6, 12, 24 and 48 postoperative hours. Subjects will be asked to make VAS evaluation of their pain. Likewise subjects will be asked if they have used any prescribed analgesics and if so, the dosage will be asked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients pain. Timepoint: 6,12,24 and 48 hours after extractio. Method of measurement: patients pain will be assessed using a VAS (Visual Analog Scale) and the number of analgesic used.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-29</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical science</contact_name>
        <contact_address>Hezarjarib st Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
