<?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>IRCT20221012056154N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-03</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>“The effect of 0.15% benzydamine mouthwash on pain perception “during local palatal injection in periodontal surgery candidates</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of 15% benzydamine mouthwash on pain perception during palatal local anesthesia injection in patients candidated for  periodontal surgery.a cross-clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66268</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Based on the gradual sampling method of visiting the clinic, the patients were divided into two groups using 0.15% benzyd amine hydrochloride mouthwash  (43 people) and using washing serum as a placebo group based on four random blocks. 43 people) are randomly assigned.
The method used to generate the random allocation sequence by mentioning the name of the software or the site used: the random allocation sequence based on www.sealede envelope.com and the Random Block software will be used online. Then, in order to hide, the sequence list in the center The dental school research will be placed in a sealed envelope. After the permission to run this clinical trial, the type of interventions will be determined from inside the envelope based on the list in the daily visits of the patients, Blinding description: Patients and operators are aware of the type of general grouping (which is divided into two categories of using benzydamine mouthwash and washing serum), but they do not know the order of entry into the grouping.. Before performing the work, two containers of the same color, whose contents cannot be distinguished from each other, are prepared by a person other than the operator and the patients, then before the operation, two containers are prepared by a person other than the operator and the patients, then Washing serum (Shahid Ghazi Company-Iran) is placed in one container and 0.15% benzyd amine hydrochloride mouthwash (Elixir Borujard Company-Iran) is placed in another container.First, group A patients are given 15cc of 0.15% benzyd amine hydrochloride mouthwash, and group B patients are given 15cc of serum to gargle for about a minute. After that, by the operator, for all the subjects, an infiltration injection with lidocaine 2% (1:100,000 epinephrine) (Exir Borujerd Company, Iran) was performed in the right posterior sextant of the upper jaw with an injection syringe and a 27 gauge dental needle with a length of 30 mm. can be The operator then scored the VAS (Vas is scored on a 100 mm horizontal line with the left endpoint marked "no pain" and the right endpoint "pain as bad as it can be.") for each patient. It registers immediately after the injection. All necessary surgical procedures are performed for each patient.In the next session, two containers whose contents cannot be distinguished from each other are prepared by someone other than the operator and the patients, in one container washing serum (Shahid Ghazi Pharmaceutical Company - Iran) and in the other container 0.15 benzyd amine hydrochloride mouthwash. % (Broujerd Elixir Company-Iran) is placed. Half of the patients who were given 15cc of 0.15% benzyd amine hydrochloride mouthwash last week are given 15cc of serum to gargle for about a minute. And vice versa, 15cc of benzydamine hydrochloride mouthwash is given to the patients who were washed with serum last week to gargle.After that, by the operator, this time for all the subjects in the left posterior sextant of the upper jaw, an infiltration injection with lidocaine 2% (1:100000 epinephrine) (Exir Borujerd Company-Iran) with an injection syringe and a 27-gauge dental needle head. 30mm is done. Then the operator records the VAS again for each patient immediately after the injection. Again, all surgical procedures are performed according to the previous procedure.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For each patient, 15cc of benzydamine hydrochloride 0.15% mouthwash (Shahid Ghazi Company, Iran) is administered for 1 minute. Intervention 2: Control group: For each patient, 15 cc of washing serum (Shahid Qazi Company - Iran) is gargled for 1 minute.</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:
Age, gender, pain level of the study group
All data can potentially be released after identifying individuals

When:
Access starts 6 months after the results are published

To whom:
For researchers working in academic and scientific institutions and people working in industry.

Conditions:
It can be used for research work or comparison with the intended study.
 It is possible to access the data by referring to the Research Science Center of Gilan Faculty of Dentistry and the person in charge, Mrs. Alavi.

Where to obtain:
It is possible to access the data by referring to the Research Science Center of Gilan Faculty of Dentistry and the person in charge, Mrs.sana Alavi. Responsible persons: Shida Dadashi Navi 09387181876 Mrs. Alavi: 09119431009

How to obtain:
First, refer to the Science Research Center of the Faculty of Dentistry. Then they will be referred to the responsible person, Mrs. Shida Dadashi Navi, after the approval of the responsible person, it is possible to access the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ashkan salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht-Saravan Road to Foman-Gilan Dental Clinic</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>Drashkan_salary@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ashkan salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Fuman road to Saravan, Gilan dental complex</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>Drashkan_salary@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People 20-60 years old / with systemic health (without cardiovascular diseases, high blood pressure, diabetes, thyroid diseases, liver, etc.)
People who need maxillary posterior sextant crown lengthening surgery.
People who need gum grafts.
People who need flap surgery in the posterior sextant of the maxilla</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Presence of diabetes, cardiovascular disease and hypertension
Smoking
Taking NSAIDS drugs in the last 6 months
Pregnancy
Taking painkillers within 24 hours before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For each patient, 15cc of benzydamine hydrochloride 0.15% mouthwash (Shahid Ghazi Company, Iran) is administered for 1 minute.</i_keyword>
      <i_keyword>Control group: For each patient, 15 cc of washing serum (Shahid Qazi Company - Iran) is gargled for 1 minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Immediately after the start of the intervention. Method of measurement: visual analogue scale.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-29</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی گیلان</contact_name>
        <contact_address>Gilan, Rasht, Namjo St., Shahid Siyadati St., in front of 17 Shahrivar Hospital rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
