<?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>IRCT201111014877N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Dental  Faculty of  Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of efficacy of gel prepared from plants of Quercus Brantii L and Coriandrum Sativum L on periodontal clinical indices.</public_title>
      <acronym>there is no acronym</acronym>
      <scientific_title>Evaluation of efficacy of topical subgingival application of gel prepared from plants of Quercus Brantii L and Coriandrum Sativum L compared with placebo gel on periodontal clinical indices in moderate chronic periodontitis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Single blind study means that the examiner who had the task of gathering information, was unaware of treatment of prescribed for each site.</study_design>
      <phase>2</phase>
      <hc_freetext>chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Ten patients were selected with moderate chronic periodontitis (with 4 or more sites with a probing depth of 3-5 mm). Totally seventy sites (pockets) were selected and divided into experimental and control sites randomly. Clinical indices: Plaque index (PI), Probing pocket depth (PPD), clinical attachment loss (CAL) and Papilla Bleeding Index (PBI) were measured before treatment. Experimental sites were treated with scaling and root planning (SRP) adjunctive topical subgingival application of gel was prepared from plants extract of Quercus Brantii L (20%) and Coriandrum Sativum L (1%) in pharmacy Faculty of Isfahan University of Medical Sciences. Gel was supplied in syringe (0.2 ml) with 21 gauge needle into the pocket. This was done two times. Also clinical indices were measured one and three months after treatment. Intervention 2: Control sites were treated with SRP and topical application of placebo gel into periodontal pockets. It was applied subgingivally using similar syringe and needle as that of experimental gel.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Jaber Yaghini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Periodontology Department, Dental Faculty, Isfahan Medical University, Hezar Jerib Avenue</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7346181746</zip>
        <telephone>+98 31 1434 2136</telephone>
        <email>j_yaghini@dnt.mui.ac.ir</email>
        <affiliation>Dental Faculty of Isfahan Medical University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Jaber Yaghini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Periodontology Department, Dental Faculty, Isfahan Medical University, Hezar Jerib Avenue</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7346181746</zip>
        <telephone>+98 31 1434 2136</telephone>
        <email>j_yaghini@dnt.mui.ac.ir</email>
        <affiliation>Dental Faculty of Isfahan Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: any systemic disease, any antibiotic therapy in last 1 month, no history of any periodontal therapy 3 months prior to the initial examination and any orthodontic therapy. Exclusion criteria: smoking habit, pregnancy, sites with severe caries and restoration, allergy to gel and other drugs used in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pericoronitis Periodontitis:•NOS•complex•simplex</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Ten patients were selected with moderate chronic periodontitis (with 4 or more sites with a probing depth of 3-5 mm). Totally seventy sites (pockets) were selected and divided into experimental and control sites randomly. Clinical indices: Plaque index (PI), Probing pocket depth (PPD), clinical attachment loss (CAL) and Papilla Bleeding Index (PBI) were measured before treatment. Experimental sites were treated with scaling and root planning (SRP) adjunctive topical subgingival application of gel was prepared from plants extract of Quercus Brantii L (20%) and Coriandrum Sativum L (1%) in pharmacy Faculty of Isfahan University of Medical Sciences. Gel was supplied in syringe (0.2 ml) with 21 gauge needle into the pocket. This was done two times. Also clinical indices were measured one and three months after treatment.</i_keyword>
      <i_keyword>Control sites were treated with SRP and topical application of placebo gel into periodontal pockets. It was applied subgingivally using similar syringe and needle as that of experimental gel.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pocket depth. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: With probe.</prim_outcome>
      <prim_outcome>Clinical attachment loss. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: With probe.</prim_outcome>
      <prim_outcome>Papilla bleeding index. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: With probe.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: With probe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tooth sensitivity. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: Visual examination.</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>Vice chancellor for research, Dental  Faculty of  Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-16</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
