<?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>IRCT20241211064021N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-21</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of propolis and chlorhexidine mouthwash on oral health and impacted mandibular wisdom teeth</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method will be used to implement random assignment. In this way, 60 consecutive numbers (from 1 to 60) will be written separately on paper and placed in a container. Then, each participant in the experiment will be asked to randomly select one of these 60 numbers from the container containing the numbers.People who chose numbers 1 to 30 will be assigned to Group A, and people who chose numbers 31 to 60 will be assigned to Group B, Blinding description: Propolis mouthwash and chlorhexidine mouthwash are produced with similar appearance, color, and odor. If possible, additives are used to make both mouthwashes look exactly the same. This is done to prevent the mouthwash from being identified based on appearance. Both mouthwashes are packaged in identical, indistinguishable bottles.In this type of blinding, neither the participants know which mouthwash they are receiving nor do the researchers who perform the clinical assessments (such as measuring gingival and plaque indices). The primary investigator codes the bottles (using numbers). This list is not made available to the researchers or participants until the end of the study.Participants are given coded bottles and told to use the mouthwash according to specific instructions (for example, twice a day after brushing their teeth).</study_design>
      <phase>3</phase>
      <hc_freetext>Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The effect of herbal mouthwash (propolis) is to rinse your mouth with 10 ml of mouthwash for 30 seconds, one hour after brushing your teeth, twice a day (morning and night), as recommended by the manufacturer, and avoid eating and drinking, and preferably rinsing your mouth. This should be done starting the night of surgery and continuing for two weeks. Intervention 2: Control group: Simultaneously uses chlorhexidine mouthwash. This group serves as a benchmark for comparison with the effect of propolis.</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:
Much of the data is potentially shareable

When:
Access to the data will be available immediately after the publication of the final article

To whom:
All researchers, researchers and clinical experts will be allowed to access the data of this study.

Conditions:
It will be welcomed to conduct extensive analysis on the data of this study along with the data of other studies to write meta-analysis review articles.

Where to obtain:
For more information, please send an email to Dr. Pouria Karimi. All correspondence will be sent to the email address: atmonero@gmail.com

How to obtain:
After making a phone call and submitting a request via email, the final answer will be sent within at least 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pouria Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmedeh st</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>atmonero@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmedeh st</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838678</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>dr_amn69@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having impacted wisdom teeth in the lower jaw
Not using other mouthwashes
Plaque index and gum index</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant people
People with cardiovascular problems
People who use antibiotic medications for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis</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: The effect of herbal mouthwash (propolis) is to rinse your mouth with 10 ml of mouthwash for 30 seconds, one hour after brushing your teeth, twice a day (morning and night), as recommended by the manufacturer, and avoid eating and drinking, and preferably rinsing your mouth. This should be done starting the night of surgery and continuing for two weeks.</i_keyword>
      <i_keyword>Control group: Simultaneously uses chlorhexidine mouthwash. This group serves as a benchmark for comparison with the effect of propolis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of gum index reduction. Timepoint: Before intervention: Assessment of the initial condition before starting to use the mouthwash. After intervention: Assessment at specific times after the start of treatment, measured on days 7 and 14. Method of measurement: They are measured using standard clinical methods, which include examination of the teeth and gums by a trained dentist and researcher. Instruments such as a probe are used to measure the depth of the gingival pocket or visual observation is used to determine the presence of plaque.</prim_outcome>
      <prim_outcome>Prevalence of dry cavity. Timepoint: Before intervention: Assessment of the initial condition before starting to use the mouthwash. After intervention: Assessment at specific times after the start of treatment, measured on days 7 and 14. Method of measurement: It is usually assessed through clinical records and reports of complications from patients after wisdom tooth extraction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patients' perception of pain or discomfort. Timepoint: Before the intervention: To assess the initial condition of the patients. During the intervention: Periodic assessment (every week and every month) to observe changes. Method of measurement: It is measured through rating scales (such as a 0 to 10 rating scale) in which patients report their level of pain.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-23</approval_date>
        <contact_name>Research Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh St Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
