<?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>IRCT20170502033770N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-11</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Persica and Protact herbal mouthwashes on the wound of gum surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of chlorhexidine, Persica and Protact mouthwash on gingival healing after crown lengthening surgery: a double-blinded randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block method will be used to assign samples to groups (type of mouthwash). First, the samples will be matched in terms of age, gender, periodontium condition and oral hygiene and people with similar status will be placed in a block. According to the total number of required samples (33 samples) and the number of mouthwashes, finally 11 blocks with matched samples will be considered as 3 samples in each block (number of mouthwashes). Selection of blocks and type of mouthwash for each sample will be done through random allocation software 2 and the samples will be placed in one of the groups by this software, Blinding description: The study is double-blind. In order to blind patients, therapists and researchers, mouthwashes are placed in dark-colored bottles with the same appearance with different labels and are prescribed along with painkillers. According to the recommendations of the manufacturers, the mouthwash instructions leaflet is given to the patients in identical envelopes with different labels according to the mouthwash label, and the patients are asked to use the relevant mouthwash according to the leaflet.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Clinical dental crown lengthening surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: This group will be given Chlorhexidine 0.2% mouthwash (Iran Najo Company) and they will be asked to use 10 ml of mouthwash and swish it in their mouth for 30 seconds twice a day in the morning and at night after brushing teeth according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg. Intervention 2: Intervention group: This group (the first intervention group) will be given Persica mouthwash (Porsina company) and they will be asked to dilute 15 drops of mouthwash with 15 ml of water and swish it in their mouth for 20 seconds 4 times a day according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg. Intervention 3: Intervention group: This group (the second intervention group) will be given Protact mouthwash (Zolangrespina company) and they will be asked to use 5 ml of mouthwash and swish it in their mouth for 1 minute 3 times a day (after breakfast, lunch and at night after brushing teeth) according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg.</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:
After the completion of the project, the results will be delivered in the form of a final report and in electronic form (on a CD) to the Vice-Chancellor of Research and Faculty of Dentistry of Mazandaran University of Medical Sciences.

When:
The decision regarding access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor.

To whom:
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor

Conditions:
The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person, and it is necessary to give reference to the data owners in the articles or wherever the data is to be used, and the use of the results only It is allowed by citing its source.

Where to obtain:
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor

How to obtain:
A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences and also obtaining the consent of the supervisor.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>حدیث احسانی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khazar Blvd, Sari Faculty of Dentistry</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816895475</zip>
        <telephone>+98 11 3325 4135</telephone>
        <email>hehsani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadis Ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khazar Blvd, Sari Faculty of Dentistry</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816895475</zip>
        <telephone>+98 11 3325 4135</telephone>
        <email>hehsani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients should be between 18 and 60.
Patients with indications for clinical crown lengthening surgery on at least one tooth.
Patients agree to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>They have used antibiotics for 10 consecutive days in the past 3 months.
They are allergic to mouthwash.
Patients have diabetes or any other systemic disease.
Patients take medications that interfere with gum healing, such as contraceptives.
They use corticosteroids.
They are pregnant or breastfeeding.
They use cigarettes.
They have pathological lesions in the oral mucosa.
They have removable dental prostheses or orthodontics.
They have periodontitis in the surgical area.
The teeth are discolored due to systemic factors or drugs.</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: This group will be given Chlorhexidine 0.2% mouthwash (Iran Najo Company) and they will be asked to use 10 ml of mouthwash and swish it in their mouth for 30 seconds twice a day in the morning and at night after brushing teeth according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg</i_keyword>
      <i_keyword>Intervention group: This group (the first intervention group) will be given Persica mouthwash (Porsina company) and they will be asked to dilute 15 drops of mouthwash with 15 ml of water and swish it in their mouth for 20 seconds 4 times a day according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg.</i_keyword>
      <i_keyword>Intervention group: This group (the second intervention group) will be given Protact mouthwash (Zolangrespina company) and they will be asked to use 5 ml of mouthwash and swish it in their mouth for 1 minute 3 times a day (after breakfast, lunch and at night after brushing teeth) according to the manufacturer's recommendation for two weeks from the night of surgery. Patients will be asked to avoid washing their mouth, eating and drinking for half an hour after using the mouthwash. Also, after surgery, all patients will be prescribed ibuprofen 400mg.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival index (GI). Timepoint: Measurement of gingival index on the day of surgery and 14 days after surgery. Method of measurement: by periodontal probe.</prim_outcome>
      <prim_outcome>Plaque index (PI). Timepoint: Measurement of plaque index on the day of surgery and 14 days after surgery. Method of measurement: by dental explorer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stain index (SI). Timepoint: 14 days after surgery. Method of measurement: by periodontal probe.</sec_outcome>
      <sec_outcome>Changing the color of the tongue. Timepoint: 14 days after surgery. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Taste of the mouthwash. Timepoint: 14 days after surgery. Method of measurement: questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Khazar Blvd, Sari Faculty of Dentistry (Tooba dental clinic) Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
