<?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>IRCT2013110215236N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-05</date_registration>
      <primary_sponsor>Laser Department, Dental School of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of gum disease</public_title>
      <acronym></acronym>
      <scientific_title>Treatment of periodontitis and chronic periodontitis and the complications</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: The patient will be under SRP (Scaling and Root planing) treatment after a clinical check-up and registering the below parameters: &#13;
1. Bleeding on probing (BOP) &#13;
2. Clinical attachment loss (CAL) &#13;
3. Plaque index (PI) &#13;
4. Full mouth plaque score (FMPS) &#13;
5. Full mouth bleeding score (FMBS) &#13;
6. Periodontal probing depth (PPD)  &#13;
In order to see that there is no dental plaque. The patients are to be checked-up in the 1st  3rd and 7th days one week after SRP every single gets radiated in 3 sessions over 3 days that every radiation is in the 1st 3rd 7th days over a week in this research. We randomly split the patients into 2 groups called beholder and goal. &#13;
The goal group: &#13;
The patients continuously go under photodynamic therapy with 810 nanometer Diode laser Having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points followed by EmuDo photosensitizer . Intervention 2: The beholder group:&#13;
The patients go under SRP treatment with physiology serum and off laser. the approved patients are to be reviewed and compared in one three and six month intervals.</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>Omid Bagherpasand Tamijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Tehran University of Medical Sciences, North Amir Abad Tst. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone></telephone>
        <email>omid.dds67@gmail.com</email>
        <affiliation>Dental School, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Monzavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone></telephone>
        <email>monzavia@sina.tums.ac.ir</email>
        <affiliation>Dental School, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This study is a double –blind randomized clinical trial and is done in a full mouth design. Totally 44 patients to be surveyed in this study . The patient have periodontal pocket with 5 mm depth and more it also needs to be mentioned that these patients have Chronic periodontitis that have not answered to phase one and the periodontal pocket is left in them. It must be said that the age rage is 35 and over it more over. These patients criteria is remaining periodontal pocket after doing phase one. More over to these facts: &#13;
1.	The patients must be without systematic disease.&#13;
2.	Pregnant patients are not to be taken part. &#13;
3.	The patients must not use drugs or smoke. &#13;
4.	The patients must not have used any antibiotic in a 6 month period.&#13;
The patients go under SRP treatment for the 2nd time after clinical check-up and registering parameters like BOP / CAL / PPD / FMBS / FMPS and PI. If one the 50 patients FMPS is lower than 20% he/she gets radiated in the 1st 2nd and 7th days during 3 sessions in 3 days.  In order to se that there is no dental plaque the patients are to be checked-up one week after doing SRP. Every patients left pocket gets radiated with Diode laser and EmunDo. The sensitive substance to light (photosensitizer) The day after check-up in the 1st 3rd and 7th days over a week. &#13;
In goal group: all teeth go under PDT with Diode laser followed by EmunDo photosensitizer having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points.&#13;
In beholder group all teeth including those that have periodontal pocket with the depth of 5 mm and more and without periodontal pocket go under SRP with physiologic serum and off laser. than the patients are to be re-studied and compared in one three and six month intervals.</inclusion_criteria>
      <agemin>35 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>Gingivitis and periodontal diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patient will be under SRP (Scaling and Root planing) treatment after a clinical check-up and registering the below parameters: &#13;
1. Bleeding on probing (BOP) &#13;
2. Clinical attachment loss (CAL) &#13;
3. Plaque index (PI) &#13;
4. Full mouth plaque score (FMPS) &#13;
5. Full mouth bleeding score (FMBS) &#13;
6. Periodontal probing depth (PPD)  &#13;
In order to see that there is no dental plaque. The patients are to be checked-up in the 1st  3rd and 7th days one week after SRP every single gets radiated in 3 sessions over 3 days that every radiation is in the 1st 3rd 7th days over a week in this research. We randomly split the patients into 2 groups called beholder and goal. &#13;
The goal group: &#13;
The patients continuously go under photodynamic therapy with 810 nanometer Diode laser Having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points followed by EmuDo photosensitizer .</i_keyword>
      <i_keyword>The beholder group:&#13;
The patients go under SRP treatment with physiology serum and off laser. the approved patients are to be reviewed and compared in one three and six month intervals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. Bleeding on probing (BOP). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed / measured probe.</prim_outcome>
      <prim_outcome>Clinical attachment loss (CAL). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed.</prim_outcome>
      <prim_outcome>Plaque index (PI). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed.</prim_outcome>
      <prim_outcome>Full mouth plaque score (FMPS). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed.</prim_outcome>
      <prim_outcome>Full mouth bleeding score (FMBS). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed.</prim_outcome>
      <prim_outcome>Periodontal probing depth (PPD). Timepoint: Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation. Method of measurement: Observed / measured 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>Laser Department, Dental School of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-11</approval_date>
        <contact_name>Office of Research Affairs (research assistant)</contact_name>
        <contact_address>Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
