<?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>IRCT20230721058874N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of chlorhexidine on pain after extraction of lower wisdom teeth</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of 2% chlorhexidine gel inside the socket on pain after surgery of the third molar of the mandible.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>17</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71707</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In each patient, in a simple random manner (by Excel software using the Randbetween function option), the impacted molar tooth on one side is considered as the case group and the other side as the control, Blinding description: Before starting the surgery, the research procedures were explained to the patient, and a consent form was obtained from him or her. On the day of the surgery, the resident  (clinician who is not blinded to the study) at Tehran Azad Dental School after surgery and tooth extraction on the Intervention side, which is chosen by simple random before the surgery, he puts chlorhexidine gel and placebo on the control side and writes the information in a form and puts it in a closed envelope and hands it to the researcher.
The patient and the researcher, who is the outcome evaluator, are blind, and after evaluating the outcome (which is the evaluation of the patient's pain in each side), he opens the information form and compares and analyzes the data.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Dry socket. Condition 2: Impacted teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: One patient's jaw, which was randomly selected, and after surgery, chlorhexidine gluconate 2% gel Morva Sept, made in Iran, in the amount of 1 ml, was applied to resorable  Roeko Gelat Amp gelofoam, made in Germany, and placed in the socket. Intervention 2: Control group: Roeko Gelat Amp absorbable gel foam made in Germany is placed in the patient's toothless socket after surgery.</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:
The research process and the main results of the research and data about the patients are accessible

When:
1 year after the results are published

To whom:
Researchers working in academic and scientific institutions and people working in industry can apply for them

Conditions:
If the patient is fully satisfied and if it is aimed at improving the patient's condition and preventing the patient's problems, the documents can be used and available

Where to obtain:
You can contact this email for correspondence and exchange of views arya.fathi77.af@gmail.com

How to obtain:
It must be for research or treatment

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Eshagh Lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>elasemi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Eshagh lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Neyestan 9 alley No 9</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>elasemi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who are 18-25 years old.
Needs bilateral extraction of mandibular impacted third molar with difficulty level of 7-10 according to Pederson criteria.
The mucus on the tooth should be healthy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with a history of systemic diseases, pregnancy, infection in the area, use of anti-coagulant drugs, presence of painful conditions such as teeth needing root canal treatment, neurological diseases and use of nerve drugs, having a history of allergies.
People who do not give consent after explaining the steps and purpose of the research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M27.3</hc_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alveolitis of jaws</hc_keyword>
      <hc_keyword>Impacted teeth</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: One patient's jaw, which was randomly selected, and after surgery, chlorhexidine gluconate 2% gel Morva Sept, made in Iran, in the amount of 1 ml, was applied to resorable  Roeko Gelat Amp gelofoam, made in Germany, and placed in the socket.</i_keyword>
      <i_keyword>Control group: Roeko Gelat Amp absorbable gel foam made in Germany is placed in the patient's toothless socket after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain after impacted mandibular third molar surgery based on Visual Analogue Scale. Timepoint: Pain assessment after 2, 12, 24, 72 hours after surgery, respectively. Method of measurement: Visual Analogue Scale Questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-14</approval_date>
        <contact_name>Ethics committee of Faculty of Dentistry of Tehran Azad University</contact_name>
        <contact_address>south Sohrevardi east Abrar alley No 5 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
