<?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>IRCT20210818052227N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-26</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, both interventions are performed in all patients. All 40 patients are given numbers from 1 to 40. In the first step, using a simple random method using a random number table, we identify 20 patients whose first surgery is on the left and another 20 patients whose first surgery is on the right. In the second stage, for 20 patients whose first surgery is on the left, using a simple random method, using a table of random numbers, we determine which 10 patients have the first surgery of a gel saturated with a combination of amoxicillin, betamethasone and ibuprofen. Which other 10 people use foam gel alone (control group). We repeat this for 20 people whose first surgery is on the right side, Blinding description: Both the patient and the researcher are blind to the study. In this way, the patient and the researcher are blind to the saturation or non-saturation of the gelfum with the innovative compound. An unsaturated gelfum is placed on one side of the mouth at the site of the extracted tooth, and the saturated gelfum is placed in place of the opposite tooth in the same extracted jaw and sutured, and the results are measured by me.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Extraction of wisdom teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Inserting gelfoam containing amoxicillin, betamethasone and ibuprofen into the silent tooth. Turn until it is impregnated with jelfum to have a longer effect and slower absorption. The patient's tooth is extracted, the saturated gelfum is placed, then two weeks later the opposite tooth is extracted, and the simple unsaturated gelfum is placed as a control, and the results are measured and evaluated. Intervention 2: Control group: Control group: placing unsaturated gelfum inside the extract of the extracted tooth.</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:
Evaluation of the Effect of an Innovative Combination Solution Containing: Amoxicillin, Betamethasone and Ibuprofen on Controlling pain, Swelling and Infection Caused by Wisdom Tooth Surgery

When:
unlimited

To whom:
unlimited

Conditions:
unlimited

Where to obtain:
mansourian77pouya@gmail.com

How to obtain:
unlimited

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pouya Mansourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17Sharivar blvd - Bahar Street</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3518794431</zip>
        <telephone>+98 23 3522 5936</telephone>
        <email>mansourian77pouya@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pouya Mansourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 sharivar blvd - bahar street</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3518794431</zip>
        <telephone>+98 23 3522 5936</telephone>
        <email>mansourian77pouya@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Has erupted wisdom teeth
Absence of systemic disease
Proper oral hygiene</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>systemic disease
Improper oral hygiene</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Embedded and impacted teeth</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: Inserting gelfoam containing amoxicillin, betamethasone and ibuprofen into the silent tooth. Turn until it is impregnated with jelfum to have a longer effect and slower absorption. The patient's tooth is extracted, the saturated gelfum is placed, then two weeks later the opposite tooth is extracted, and the simple unsaturated gelfum is placed as a control, and the results are measured and evaluated.</i_keyword>
      <i_keyword>Control group: Control group: placing unsaturated gelfum inside the extract of the extracted tooth</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing pain. Timepoint: Patients are told to report the problem in case of severe pain and discomfort. The VAS form is given to patients to record the amount of pain: 12 and 24 hours after surgery and on 2-3-4-5-6-7 days after surgery. Method of measurement: Through the VAS chart.</prim_outcome>
      <prim_outcome>Inflammation control. Timepoint: The same amount of swelling is measured 42 hours after surgery and on the morning of the 3rd and 7th days after surgery. Method of measurement: Facial width is calculated by marking 5 pink spaces on a piece of yarn and then measuring it with a ruler. Horizontal distance: The distance between the corner of the lip to the junction of the auricular lobule (Earlobe) on the same side and the piece of thread follow the convexity of the cheek. Vertical: The distance between the outer canthus of the eye to the mandibular angle of the same side and the piece of thread follow the convexity of the face. Mile: The distance from the corner of the lip to the angle of the mandible on the same side and the piece of floss should follow the possible convexity of the face (swelling after surgery). During these three measurements, the patient lies supine on the unit and the receiver is on the desired side.</prim_outcome>
      <prim_outcome>Infection control. Timepoint: In terms of pus, heat and redness in the desired area. Method of measurement: Zero and one technique (zero: no infection and one: infection).</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-04</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>17 shahrivar bvld ; dental univesity semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
