<?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>IRCT2017030932749N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-23</date_registration>
      <primary_sponsor>Vice chancellor for research,isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Effectiveness of Photodynamic Therapy with Low-level Diode Laser in Nonsurgical Treatment of Peri-implantitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Effectiveness of Photodynamic Therapy with Low-level Diode Laser in Nonsurgical Treatment of Peri-implantitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25435</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>peri-implantitis or inflamatory condition around dental implant.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)&#13;
oral hygiene instruction (modified bass method) and flossing. (educational intervention)&#13;
two weeks later Photo Dynamic Therapy applied. (810 nm Diode laser+ Emundo Photosensitizer)&#13;
and this protocole repeated in two weeks after. &#13;
*EmonDo: indocyanine green /A.R.C. laser Gmbh, Germany&#13;
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany. Intervention 2: control group:&#13;
Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)&#13;
oral hygiene instruction (modified bass method) and flossing. (educational intervention)&#13;
two weeks later peri implantitis treated with 810 nm Diode laser. &#13;
and this protocole repeated in two weeks after.&#13;
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany.</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>mahboobe Rajabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>birjand dental school/pasdaran 3 st</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3223 4715</telephone>
        <email>m.rajabzadeh@bums.ac.irm.rajabzadeh6630@gmail.commahboobe_6630@yahoo.com</email>
        <affiliation>isfahan dental school</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mahboobe rajabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>birjand dental school</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3223 4715</telephone>
        <email>m.rajabzadeh@bums.ac.irm.rajabzadeh6630@gmail.commahboobe_6630@yahoo.com</email>
        <affiliation>isfahan dental school</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria:&#13;
1. 4-6 mm pocket depth &amp; 0.5-2 mm marginal bone loss&#13;
2. 2mm or more attached gingiva around implant&#13;
3. no systemic disease &#13;
4.no tobacco use &#13;
5.no use of antibiotics and drugs within previous 1month&#13;
6.no periodontal treatment except scaling and root planning within previous 2years&#13;
The exclusion criteria:&#13;
1.use of alcohol or tobacco 2.pregnancy or breastfeeding 3. use of antimicrobial agents during the previous 2 months 4. history of periodontal surgery during the previous year. 5. poor oral hygiene and no cooperation 6. need to gingival graft,with out attached gingiva</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>67 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)&#13;
oral hygiene instruction (modified bass method) and flossing. (educational intervention)&#13;
two weeks later Photo Dynamic Therapy applied. (810 nm Diode laser+ Emundo Photosensitizer)&#13;
and this protocole repeated in two weeks after. &#13;
*EmonDo: indocyanine green /A.R.C. laser Gmbh, Germany&#13;
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany</i_keyword>
      <i_keyword>control group:&#13;
Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)&#13;
oral hygiene instruction (modified bass method) and flossing. (educational intervention)&#13;
two weeks later peri implantitis treated with 810 nm Diode laser. &#13;
and this protocole repeated in two weeks after.&#13;
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Probing depth measurement. Timepoint: before intervention/ 3month after intervention. Method of measurement: with periodontal probe/ milimeter.</prim_outcome>
      <prim_outcome>Papilla bleeding index. Timepoint: before intervention/ 3month after intervention. Method of measurement: index definition/ score to bleeding on probing.</prim_outcome>
      <prim_outcome>Modified plaque index. Timepoint: before intervention/ 3month after intervention. Method of measurement: index definition/ plaque accumulation rate.</prim_outcome>
      <prim_outcome>Microbial specimen. Timepoint: before intervention/ 3month after intervention. Method of measurement: microbial culture  of crevicular gingival fluid / PCR.</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,isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-31</approval_date>
        <contact_name>isfahan medical sciences ethics committee</contact_name>
        <contact_address>hezar jarib st/ isfahan isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
