<?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>IRCT20240302061143N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-25</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Propolis and chlorhexidine mouthwashes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Propolis and chlorhexidine mouthwashes on some complications of impacted mandibular Third molar extraction surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, the allocation of participants will be done based on the randomization method and by using dice. After selecting people according to the calculated sample size, numbers 1, 3, and 5 are considered for group A  and numbers 2, 4, and 6 for group B, Blinding description: In order to make the study blind, 40 similar containers were prepared by the first colleague, and  A label and B label will be transferred to the containers, and without the knowledge of the second colleague, the contents of each label will be delivered to him, and after the completion of the first surgical procedure, the patients will be The second colleague is randomly divided into two groups, A and B, and the mouthwash of the same group is delivered to the patient, then after three weeks of the first surgery, the patient comes for the second surgery of the impacted tooth on the opposite side, and this time the second mouthwash, which is different It is given with the first one.</study_design>
      <phase>3</phase>
      <hc_freetext>Complications of impacted mandibular Third molar extraction surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  Chlorhexidine 0.02 mouthwashes,Iran Daru Pharmaceutical Company, for one week, twice a day after breakfast and before going to bed, rinse the mouth for 30 seconds. Intervention 2: Intervention group 2: Propolis mouthwashe, Soren Tech Toos Company, for one week, twice a day after breakfast and before going to bed, rinse the mouth for 30 seconds.</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 participants’ data, including age, gender, pre- and post-study results, will be disclosed at the conclusion of the study at the discretion of the project manager.

When:
Access to the data in question will commence one year after the publication of the results.

To whom:
Researchers, professors, and students with an official document from a research institute, university, industrial, or pharmaceutical centers.

Conditions:
The data will be accessible to offer guidance on conducting a study or designing similar studies, and there is also the option to undertake meta-analysis studies in collaboration with the project manager; under no other circumstances is the utilization of the data permitted.

Where to obtain:
Applicants can correspond with Dr. Meysam Bigdelou, as the project manager, to receive data.

How to obtain:
Issuing certificates from research, academic, and industrial institutions endorsed by that center to meet data requirements and providing a clear explanation of their objectives concerning the data and how the data will be utilized.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Meysam Bigdelou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Dr. Yousef Sobouti Boulevard, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>024330180</telephone>
        <email>m_bigdelou@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Meysam Bigdelou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Dr. Yousef Sobouti Boulevard, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3314 8256</telephone>
        <email>m_bigdelou@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Above 18 years old
Healthy people (ASA I or II) (healthy people, a person who has a mild systemic disease and the disease is under control and has not caused any restrictions to the patient)
People who need bilateral mandibular impacted third molar surgery (with impact grade one and A based on the Pelland Gregory standard)
Not taking antibiotics for at least 2 weeks
Absence of any inflammation and acute infection in the surgical area
Absence of pregnancy and breastfeeding
Absence of smoking and tobacco addiction
Not allergic to honey</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation and adherence to protocols
Smoking and tobacco use</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  Chlorhexidine 0.02 mouthwashes,Iran Daru Pharmaceutical Company, for one week, twice a day after breakfast and before going to bed, rinse the mouth for 30 seconds.</i_keyword>
      <i_keyword>Intervention group 2: Propolis mouthwashe, Soren Tech Toos Company, for one week, twice a day after breakfast and before going to bed, rinse the mouth for 30 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of swelling. Timepoint: Before the intervention, 2 and 7 days after the intervention. Method of measurement: Tragus to midline distance and mandible angle to dental midline using a ruler.</prim_outcome>
      <prim_outcome>Pain level. Timepoint: Before the intervention, 2 and 7 days after the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Mouth opening rate. Timepoint: Before the intervention, 2 and 7 days after the intervention. Method of measurement: The distance between upper and lower central teeth using a ruler.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-20</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Dr. Yousef Sobouti Boulevard, Zanjan Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
