<?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>IRCT2013032212847N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-29</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Shahid Sadoghi University of Medical Science</primary_sponsor>
      <public_title>The effect of Doxycycline on periodontal treatment in diabetics and non diabetics</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of sub-antimicrobial dose Doxycycline  as an adjuvant on periodontal treatments in diabetics and non diabetics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12868</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Indeed, this study is in the form of two Clinical Trial Studies, which are concurrently done in order to evaluate the effect of Doxycycline 20 mg on periodontal treatment of diabetic and non diabetic patients. Diabetic and non diabetic patients were randomly divided into two interventional and control groups, even numbers added to intervention group and odd numbers added to control group. The intervention in this study is Doxycycline capsules as scaling and root planning is done for all patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Moderate to Severe Chronic Periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 1, then oral Doxycycline 20 mg which was made by a drugstore as much as need for this study is prescribed bid (every 12 hours( for 3 months. It is available in capsules by dose of 100 mg in Iran, but by mixing the content of 100 mg capsules with the starch doses of 20 mg has been identified. Intervention 2: Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 2. Intervention 3: Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 3, then Doxycycline 20 mg which was made by a drugstore is prescribed bid for 3 months. Intervention 4: Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 4.</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>Arezoo Khabazian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Dental School, Fazaye Sabz Sq. Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1621 2222</telephone>
        <email>arezookhabazian@yahoo.com</email>
        <affiliation>Shahid Sadoghi University of Medical Science-Yazd Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Haerian Ardakani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Fazaye Sabz Square- Yazd Dental School</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1621 2222</telephone>
        <email>ahmad.haerian@gmail.com</email>
        <affiliation>Shahid Sadoghi University of Medical Science-Yazd Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: Patients have at least 14 teeth, at least 8 pockets with PD (Probing Depth)≥5 mm and CAL (Clinical Attachment Level)≥ 4 mm،  do not be sensitive to Doxycycline family, do not use interfering drugs with Tetracycline (Anti Coagulants and Oral Contraceptives) and do not have antibiotic therapy or periodontal therapy in 4 months ago.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k05.3, E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic Periodontitis, Diabetes Mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 1, then oral Doxycycline 20 mg which was made by a drugstore as much as need for this study is prescribed bid (every 12 hours( for 3 months. It is available in capsules by dose of 100 mg in Iran, but by mixing the content of 100 mg capsules with the starch doses of 20 mg has been identified.</i_keyword>
      <i_keyword>Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 2.</i_keyword>
      <i_keyword>Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 3, then Doxycycline 20 mg which was made by a drugstore is prescribed bid for 3 months.</i_keyword>
      <i_keyword>Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 4.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Probing depth. Timepoint: Before intervention and 3 months after intervention. Method of measurement: On millimeter scale and by William’s probe.</prim_outcome>
      <prim_outcome>Clinical attachment level. Timepoint: Before intervention and 3 months after intervention. Method of measurement: On millimeter scale and by William’s probe.</prim_outcome>
      <prim_outcome>Bleeding on probing. Timepoint: Before intervention and 3 months after intervention. Method of measurement: According to percentage of areas which have bleeding.</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, Shahid Sadoghi University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-06</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoghi University of Medical Science-Yazd Dental School</contact_name>
        <contact_address>Yazd- Fazaye Sabz Square Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
