<?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>IRCT2017061734582N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-23</date_registration>
      <primary_sponsor>zahdan university of medical siences</primary_sponsor>
      <public_title>Effect of ciprofloxacin on advanced chronic periodontitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of adjuvant therapy with ciprofloxacin in non-surgical treatment of sever chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26395</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This double-blind clinical and place be-controlled trial  is conducted on the patients affected with severe chronic periodontist reoffering to the periodontics department of dentistry faculty of Zahedan University of medical Sciences . the patients , who keep the required conditions are involved into the study it they are satisfied studying the terms . In addition , the consent form is filled by the patient , while the following Indexes are measured in these patients and registered in their information from.&#13;
Gingival bleeding index (GBI): In this method , each tooth is slowly probed in six places using a periodontal probe, mesial , mid and distal are scored on the both of Bacall and lingual  surface , while bleeding is scored based on the presence or lack of presence of bleeding , as well the number of bleeding sites (14).&#13;
Periodontal pocket Depth (PPD) : the distance between sulcus depth to gum margin of the available teeth , pocket depth in the mesiobuccally and  dentilingual using   Williams periodontal probe will be measured , wile factional measured , wile fractional measurements are rounded to the nearest number for one mm.    &#13;
Clinical attachment level : the distance between sulcus depth to CEJ of all the available teeth , CAL in the mesiobuccall surfaces , midbacal , Distobuccall, mesio lingual , midlingual , distolingual using Williams periodontal probe (hu-friedy , Chicago . IL ,USA), wile the mesurments are rounded to the nearest number for one mm.&#13;
All of the patients will be completely scaled and root surface probed . hygiene training will be given to all of the patients  same (tooth brushing , which is done based on the muddied Stallman method in the  periodontal patients with reduction , while it will be done based on the bas method in the patients without reduction, as  well use of dental floss).&#13;
Of antimicrobial mouth wash during the study .&#13;
After completion of SRP , the patients randomly divided in two equal test group and control  group using Black randomization method .&#13;
In this study , the medicine is provided by the plan executor for the  researcher , who gives them to the patients while he does not know the delivered medicine type.&#13;
In this study , two ciprofloxine antibiotic 500 mg (Dorou pakhsh  company ) is given to the case group per day for 7 days.&#13;
While , Darounama   capsule (placebo ) is prescribed for the control group with same doze and day frequency .&#13;
In this study , the patient and prescriber have no information about the consumption medicine . After starting the study . the patients refer to evaluate their hygiene status , as well measuring and registering clinical Indexes , while they are trained about hygiene . the amount of index plaque of all patients are kept less than ,25 percent . based on O’Leary index , However , it the patient involves a problem , will be excluded . these people not collaborate.&#13;
It must be mentioned that ,all of the data will be registered by the same person.</study_design>
      <phase>2-3</phase>
      <hc_freetext>sever chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: In this study, for the case group, ciprofloxacin 500 milligrams of daroo pakhsh company were given two days daily for 7 days. Intervention 2: In this study, for the control group, placebo 500 milligrams of daroo pakhsh company were given two days daily for 7 days.</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.masood bamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dentistry zahdan university</address>
        <city>zahdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3342 9519</telephone>
        <email>e.kalvand@zaums.ac.ir</email>
        <affiliation>dentistry zahdan university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.masood bamedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dentistry zahdan university</address>
        <city>zahdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 54 3342 9519</telephone>
        <email>e.kalvand@zaums.ac.ir</email>
        <affiliation>dentistry zahdan university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria :Age upper 18 years old؛ Presence of twenty teeth of least؛Affection with spread mean to severe chronic periodontitis	At least (3-5 min clinical attachment loss in more thou 30 percent of the mouth areas .    &#13;
&#13;
Exclusion criteria: Lack of patient’s coloration؛ Antibiotic therapy doing the third past months؛Allergy background for ciprofloxacin؛ Smoking people or addicted to tobacco؛ Affection with systemic diseases , which are effective on the periodontal conditions such as diabetes , blood disorders and immune system؛ &#13;
Pregnant women؛ Periodical Intervention Performance during the third past months؛People who are under treatment    with warfarin , antacid  T and Cyclosporine.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 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 periodontitis      Chronic pericoronitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, for the case group, ciprofloxacin 500 milligrams of daroo pakhsh company were given two days daily for 7 days</i_keyword>
      <i_keyword>In this study, for the control group, placebo 500 milligrams of daroo pakhsh company were given two days daily for 7 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival bleeding index(GBI). Timepoint: the first, scond and fourth months. Method of measurement: bleeding-non bleeding.</prim_outcome>
      <prim_outcome>Probing depth(PD). Timepoint: the first, scond and fourth months. Method of measurement: Based on Periodontal Probe williams.</prim_outcome>
      <prim_outcome>Clinical attachment level(CAL). Timepoint: the first, scond and fourth months. Method of measurement: Based on Periodontal Probe williams.</prim_outcome>
      <prim_outcome>Drug. Timepoint: First month for 7 days, two capsules a day. Method of measurement: Based on the presence or absence of consumption.</prim_outcome>
      <prim_outcome>Time. Timepoint: the first, scond and fourth months. Method of measurement: Based on the onset of a therapeutic intervention.</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>zahdan university of medical siences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-05</approval_date>
        <contact_name>zahdan university af medical siences</contact_name>
        <contact_address>zahdan university af medical siences zahdan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>zahedan university of medical siences</contact_name>
        <contact_address>zahedan university of medical siences zahdan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
