<?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>IRCT20230212057392N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-03</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Iranian Propolis mouthwash on some complications of mandibular impacted third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Iranian Propolis mouthwash on some complications of mandibular impacted third molar surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The people who referred to the personal office of oral, maxillofacial surgery specialist for mandibular impacted third molar surgery were randomly divided into two equal control and intervention groups .Randomization was carried out in such a way that patients were given numbers according to the day and time of their visit to the office, and the numbers were randomly assigned to two intervention and control groups using Excel, Blinding description: The packaging bottles of the two mouthwashes had a completely similar appearance, and the surgeon and the patient did not know which mouthwash they had used.</study_design>
      <phase>3</phase>
      <hc_freetext>A patient who needs surgery for an impacted third molar of the mandible (with vertical impaction and grades I and A according to the Pell and Gregory criteria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the surgical procedure, the intervention group was given Iranian propolis mouthwash. The mouthwash used contained 1% propolis with a salt concentration of 0.25%, which was prepared in the laboratory of the Faculty of Dentistry. The patient was instructed to swish 15 ml of mouthwash in the mouth for one minute for a week, twice a day after breakfast and before bed, and then remove it from the mouth, and to refrain from eating and drinking for 30 minutes. Intervention 2: Control group: For the control group, according to the usual oral surgery procedure, a bottle containing 0.2% chlorhexidine mouthwash (V-One, Tabriz, Iran) was given. The patient was instructed to swish 15 ml of the mouthwash in the mouth for one minute twice a day for one week after breakfast and before going to bed, and then to remove it from the mouth, and to refrain from eating or drinking for 30 minutes. It should be noted that the packaging bottles of the two mouthwashes had a completely similar appearance. surgeon and the patient were unaware of which mouthwash they had used. Also, patients were not allowed to use any other mouthwash during the study period.</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:
Only a part of the data, such as the information related to the main result or the like, can be shared

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Respecting the author's rights

Where to obtain:
through the mail address faezeh.aghamolaei1997@gmail.com

How to obtain:
A period of one month after the request by postal address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali nabavizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry , Muftah St</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717931136</zip>
        <telephone>+98 34 3428 0031</telephone>
        <email>alinabavizadeh@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Nabavizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Muftah St.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717931136</zip>
        <telephone>+98 34 3428 0008</telephone>
        <email>alinabavizadeh@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy people (ASA I or II)
The impacted third molar of the mandible (with vertical impact and grades I and A according to the Pell and Gregory criteria
People have not taken any type of antibiotics at least two weeks before surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and lactating people
People under 18 years old
People who are allergic to honey
Tobacco user</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After the surgical procedure, the intervention group was given Iranian propolis mouthwash. The mouthwash used contained 1% propolis with a salt concentration of 0.25%, which was prepared in the laboratory of the Faculty of Dentistry. The patient was instructed to swish 15 ml of mouthwash in the mouth for one minute for a week, twice a day after breakfast and before bed, and then remove it from the mouth, and to refrain from eating and drinking for 30 minutes.</i_keyword>
      <i_keyword>Control group: For the control group, according to the usual oral surgery procedure, a bottle containing 0.2% chlorhexidine mouthwash (V-One, Tabriz, Iran) was given. The patient was instructed to swish 15 ml of the mouthwash in the mouth for one minute twice a day for one week after breakfast and before going to bed, and then to remove it from the mouth, and to refrain from eating or drinking for 30 minutes. It should be noted that the packaging bottles of the two mouthwashes had a completely similar appearance. surgeon and the patient were unaware of which mouthwash they had used. Also, patients were not allowed to use any other mouthwash during the study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Swelling. Timepoint: Before surgery, the second and seventh days after surgery. Method of measurement: The amount of swelling was measured based on the change of facial reference points. The distances between the reference points were measured and recorded using a cloth meter. These distances included the tragus to the midline of the tooth and the angle of the mandible to the midline of the tooth, which was measured with a tape measure.</prim_outcome>
      <prim_outcome>The maximum amount of mouth opening. Timepoint: Before surgery, the second and seventh days after surgery. Method of measurement: The patient was asked to open his mouth straight as far as he could so that he did not have any jaw deviation and did not suffer pain, then the distance between the upper and lower centers was measured with a ruler.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Second and seventh day after surgery. Method of measurement: Visual analog scale control and evaluation method.</prim_outcome>
      <prim_outcome>Number of painkillers used. Timepoint: Second and seventh day after surgery. Method of measurement: 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-07</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Central Organization - Imam Ali Boulevard Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
