<?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>IRCT20140817018834N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>ٍEffect of lemon verbena mouthwash on gingivitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of lemon verbena mouthwash on gingivitis in comparison with chlorhexidine: A clinical study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57014</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple.
Patients will be randomly divided into three groups using a table of random numbers. A random number is assigned to each group and the intervention is determined accordingly. Each patient is given a code.
For blinding with the help of random numbers and specified code, the type of intervention is placed in the envelope. The type of intervention is the use of mouthwash (including chlorhexidine, lemon verbena and placebo). Necessary instructions and how to use are given to the patient, Blinding description: The three mouthwashes used in the study are packaged in exactly the same plastic bottles.Therefore, these mouthwashes can be masked in terms of shape. Therefore, the study is performed unknowingly in two ways and the patient and the dentist (evaluator) are masked.The treatment protocol used in the pilot research project is as follows:

The patient refers to the researcher (pharmacist) and is randomly assigned to one of the groups based on the codes. The researcher provides one of the mouthwashes to the patient based on the assigned code. The patient is referred to a study dentist and is prescribed by a dentist.After recording the results (efficiency), the results are provided to the person performing the data analysis (clinical pharmacist) in the form of code.Data analysis is performed without the knowledge of the person analyzing the type of mouthwash and the name of the patient, only based on the provided codes.</study_design>
      <phase>3</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 20 patients should use lemon verbena mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education. Intervention 2: 20 patients should use 0.2% chlorhexidine mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education. Intervention 3: Control group: 20 patients should use placebo mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.</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:
The data is related to the main consequence after unidentifiable people are shared

When:
6 month after printing the results.

To whom:
Researchers working in academic institutions

Conditions:
If you are to submit a article to a journal, they will be asked to receive the data.

Where to obtain:
Person responsible for scientific study. nasran@mums.ac.ir

How to obtain:
Sending an email to the given address and waiting time to receive a response less than a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>nasran@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad faculty of dentistry, Vakil Abad Blv , Mashhad, Razavi khorasan province</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>nasran@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>average gingival index of all teeth at least 1
average plaque index of all teeth at least 1
average probing depth of all teeth maximum 3mm
without clinical attachment loss</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
Systemic diseases that cause generalized gingivitis
Lack of refer for follow-up
Lack of oral hygiene</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis, plaque induced</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 20 patients should use lemon verbena mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.</i_keyword>
      <i_keyword>20 patients should use 0.2% chlorhexidine mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.</i_keyword>
      <i_keyword>Control group: 20 patients should use placebo mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival index, plaque index, bleeding index. Timepoint: The beginning of the study (before the intervention) and 15 and 30 days after the start. Method of measurement: View and use the probe.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-21</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences_Mashhad faculty of dentistry</contact_name>
        <contact_address>Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
