<?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>IRCT20250120064446N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-07</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The impact of chlorhexidine mouthwash and  chlorhexidine-boric acid mouthwash combination on complications following wisdom tooth surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating and comparing the effects of chlorhexidine mouthwash and chlorhexidine-boric acid mouthwash  combination on the improvement of complications following mandibular third molar surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81432</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study will consist of three groups:  
- Group A: Combined mouthwash containing chlorhexidine and boric acid.  
- Group B: Chlorhexidine mouthwash.  
- Group C: Placebo mouthwash
Participant allocation will be carried out using the block randomization method. The final sample size will include 36 participants.  
The blocks will be arranged in triplets following an A،B and C combination. A total of six blocks will be used, with the following sequence:
1:ABC
2:ACB
3:BAC
4:BCA
5:CBA
6:CAB
For block selection, a random numbers table will be used. The process begins from the first number in the table, moving from  left to right. When encountering a number between 1 and 6, the corresponding block is selected, while numbers outside this range are skipped, Blinding description: Patients are unaware of the type of mouthwash they will receive post-surgery.</study_design>
      <phase>3</phase>
      <hc_freetext>complications following mandibular third molar surgery..</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Patients will receive a combined mouthwash containing 0.2% chlorhexidine and 2% boric acid. They will start using the mouthwash the day after the surgical procedure and will apply it twice daily. The mouthwash is formulated in the Biochemistry Laboratory of Kurdistan University of Medical Sciences using( Vi-One) chlorhexidine mouthwash and( Digi Shimi) boric acid 98%. Intervention 2: Intervention group: Patients will receive a 0.2% chlorhexidine mouthwash. They will begin using the mouthwash the day after the surgical procedure and will use it twice daily.  The( Vi-One ) chlorhexidine mouthwash will be used. Intervention 3: Control Group: Patients will receive a placebo mouthwash. They will begin using the mouthwash the day after the surgical procedure and will use it twice daily. The placebo mouthwash is formulated in the Biochemistry Laboratory of Kurdistan University of Medical Sciences. Preparation Method: Distilled water is poured into a sterile beaker and heated to a stable temperature of 40–50°C.Polysorbate 20 is then added as a surfactant and stirred until fully dissolved .To mimic the texture and sensation of the original mouthwash, 10% ethanol and glycerin are gradually incorporated .Finally, peppermint essence is added to replicate the taste and aroma of chlorhexidine mouthwash, and food coloring is used to match its appearance.</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:
All data is potentially shareable after unidentified individuals.

When:
Access start of published the result.

To whom:
Researchers working in academic and scientific institution.

Conditions:
Researchers have access to the data under circumstances.

Where to obtain:
For more information, you can contact the corresponding author via the following email. esmaeilmohammdyan@gmail,com

How to obtain:
The applicant has unlimited access to the data after sending the request via email to the corresponding author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Esmaeil mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3324 4990</telephone>
        <email>esmaeilmohammdyan@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hady Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3324 4990</telephone>
        <email>Hadymohammadi1361@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for impacted mandibular third molar surgery are referred to the Oral Surgery Department of the Faculty of Dentistry, Kurdistan University of Medical Sciences.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of mental disorders.
The presence of underlying, autoimmune and systemic diseases.</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Patients will receive a combined mouthwash containing 0.2% chlorhexidine and 2% boric acid. They will start using the mouthwash the day after the surgical procedure and will apply it twice daily. The mouthwash is formulated in the Biochemistry Laboratory of Kurdistan University of Medical Sciences using( Vi-One) chlorhexidine mouthwash and( Digi Shimi) boric acid 98%.</i_keyword>
      <i_keyword>Intervention group: Patients will receive a 0.2% chlorhexidine mouthwash. They will begin using the mouthwash the day after the surgical procedure and will use it twice daily.  The( Vi-One ) chlorhexidine mouthwash will be used</i_keyword>
      <i_keyword>Control Group: Patients will receive a placebo mouthwash. They will begin using the mouthwash the day after the surgical procedure and will use it twice daily. The placebo mouthwash is formulated in the Biochemistry Laboratory of Kurdistan University of Medical Sciences. Preparation Method: Distilled water is poured into a sterile beaker and heated to a stable temperature of 40–50°C.Polysorbate 20 is then added as a surfactant and stirred until fully dissolved .To mimic the texture and sensation of the original mouthwash, 10% ethanol and glycerin are gradually incorporated .Finally, peppermint essence is added to replicate the taste and aroma of chlorhexidine mouthwash, and food coloring is used to match its appearance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The extent of pain after mandibular third molar surgery in patients using chlorhexidine mouthwash and a combination of chlorhexidine and boric acid mouthwash. Timepoint: 24 and 48 hours post surgery. Method of measurement: Questionnaire visual analog scale.</prim_outcome>
      <prim_outcome>: The extent of trismus after mandibular third molar surgery in patients using chlorhexidine mouthwash and a combination of chlorhexidine and boric acid mouthwash. Timepoint: 24 and 48 hours post surgery. Method of measurement: Comparison of the inter incisal distance pre- and post-surgery.</prim_outcome>
      <prim_outcome>The extent of  swelling  after mandibular third molar surgery in patients using chlorhexidine mouthwash and a combination of chlorhexidine and boric acid mouthwash. Timepoint: 24 and 48 hours post surgery. Method of measurement: Comparison of the distances between reference points pre- and post-surgery, including the distance from the tragus to the dental midline and from the angle of the mandible to the dental midline.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-17</approval_date>
        <contact_name>Ethics committee of Kurdistan university of Medical Science</contact_name>
        <contact_address>Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
