<?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>IRCT2014081718834N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-07</date_registration>
      <primary_sponsor>Vice chancellor for research of Shahid Sadoughi Dental Faculty</primary_sponsor>
      <public_title>Effect of phenytoin mucoadhesive paste 1% on periodontal parameters</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of phenytoin mucoadhesive paste 1% after non-surgical therapy on improvement of periodontal status in moderate to severe chronic periodontitis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: In control side after the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients. This placebo paste is contained of  50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week. Intervention 2: After the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients.To prepare Phenytoin paste one gram of phenytoin powder was mixed with 50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week.</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 Nahid Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontics, Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1621 2623</telephone>
        <email>nasrabadi.nahid@gmail.com</email>
        <affiliation>Dental school of Yazd</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Nahid Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontics, Shahid Sadoughi Dental Faculty, Dahey Fajr BLV, Imam Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1621 2623</telephone>
        <email>nasrabadi.nahid@yahoo</email>
        <affiliation>Dental school of Yazd</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were considered as follows: having ability to read and write, no systemic diseases such as diabetes or heart disease, not taking medications affecting periodontium (anti- hypertensives, immune suppressants and anticonvulsants), not being pregnant, no smoking, no traumatic occlusion, no history of antibiotic therapy within the last three months, having at least two similar teeth on each sextants without any decays or restorations and filling informed consent form. In addition we consulted with internist about any drug interactions to phenytoin in patients of our study. The exclusion criteria were considered as follows: 1)   inappropriate control plaque during the study. 2) irregular use of pastes on the basis of given instructions 3)   not taking part in following up appointments.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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 periodontitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control side after the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients. This placebo paste is contained of  50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week.</i_keyword>
      <i_keyword>After the first phase of periodontal treatment was accomplished which including oral hygiene instructions, scaling and root planning, instructions about the application of the paste was given to all patients.To prepare Phenytoin paste one gram of phenytoin powder was mixed with 50 grams of mucoadhesive polymers including carbomer 934 and (Hydroxypropyl)methyl cellulose (1:1 w/w). subsequently, the mixed powders were gradually livigated with 50 grams of liquid paraffin.patients should use the paste on the buccal surface of determined side twice a day after tooth-brushing and using dental floss for a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pocket depth. Timepoint: 4 weeeks. Method of measurement: milimeters by Williams’s periodontal probe.</prim_outcome>
      <prim_outcome>Bleeding on probing. Timepoint: 4 weeks. Method of measurement: percentage.</prim_outcome>
      <prim_outcome>Modified gingival index. Timepoint: 4 weeks. Method of measurement: grading by observation.</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>Vice chancellor for research of Shahid Sadoughi Dental Faculty</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-11</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences of Yazd</contact_name>
        <contact_address>Shahid Bahonar Square, Yazd, Iran Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
