<?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>IRCT201309119260N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-12</date_registration>
      <primary_sponsor>this study was self-funded by researchers.</primary_sponsor>
      <public_title>PDT in treatment of peri-implant diseases</public_title>
      <acronym>PDT= PhotoDynamicTherapy</acronym>
      <scientific_title>Efficacy of antimicrobial photodynamic therapy as an adjunctive to mechanical debridement in the treatment of peri-implant diseases: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: this is single-blind split mouth clinical trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>peri-implant diseases.</hc_freetext>
      <i_freetext>control: All implants underwent mechanical debridement, using plastic curettes followed by pocket irrigation with sterile saline. Hand instrumentation was carried out until the operator was assured that the implant surfaces were adequately debrided and no time restriction was considered. In control group, no further treatment was performed. &#13;
intervention: in the PDT group, closed surface scaling followed by single-episode of photodynamic therapy. High medium photosensitizerwas injected inside the instrumented peri-implant pocket with a thin blunt needle, as far as mucosal margin starting from the apical portion of the pocket. The photosensitizer was left in the pocket for 3 minutes. Subsequently, the light emitting device  with the wavelength of 630 nm and the intensity of 2000 mw/cm2, with a special tip was placed at the depth of pocket, according to the manufacturer’s instruction. The device, used in this research for implant surface irradiation, was in contact with 6 aspects per implant. Every aspect of implants was irradiated for 20 seconds, making a total of 2 minutes..</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. mohammadreza karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>department of periodontology, no 4, 10th neyestan, pasdaran street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2276 3449</telephone>
        <email>m_karimi@dentaliau.ac.ir</email>
        <affiliation>islamic azad university, dental branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammadreza Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>department of periodontology, no 4, 10th neyestan, pasdaran street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2276 3449</telephone>
        <email>m_karimi@dentaliau.ac.ir</email>
        <affiliation>islamic azad university, dental branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Presence of at least two screw type titanium dental implants, in different sites, exhibiting clinical and radiographic signs of peri-implant diseases (including peri-implant mucositis and peri-implantitis).&#13;
•	No implant mobility&#13;
•	No evidence of occlusal overload&#13;
•	No treatment of peri-implant diseases for the least 6 months before the study&#13;
•	No use of antibiotics and anti-inflammatory drugs for the 3 months prior treatment. If these drugs were taken during the study, patient would be excluded.&#13;
•	At least 1 year function of implants.&#13;
•	No pregnancy and nursing&#13;
•	No uncontrolled diabetes (HbA1c &lt; 7)&#13;
•	In the cases that subjects had a history of periodontitis, only subjects were included if the lesions were treated at the remaining teeth and diseases was halted.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K00-K14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>k05.6</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control: All implants underwent mechanical debridement, using plastic curettes followed by pocket irrigation with sterile saline. Hand instrumentation was carried out until the operator was assured that the implant surfaces were adequately debrided and no time restriction was considered. In control group, no further treatment was performed. &#13;
intervention: in the PDT group, closed surface scaling followed by single-episode of photodynamic therapy. High medium photosensitizerwas injected inside the instrumented peri-implant pocket with a thin blunt needle, as far as mucosal margin starting from the apical portion of the pocket. The photosensitizer was left in the pocket for 3 minutes. Subsequently, the light emitting device  with the wavelength of 630 nm and the intensity of 2000 mw/cm2, with a special tip was placed at the depth of pocket, according to the manufacturer’s instruction. The device, used in this research for implant surface irradiation, was in contact with 6 aspects per implant. Every aspect of implants was irradiated for 20 seconds, making a total of 2 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Peri-implant probing pocket depth. Timepoint: before treatment, 1.5 and 3 months after treatment. Method of measurement: millimeter using williams plastic probe.</prim_outcome>
      <prim_outcome>Peri-implant clinical attachment loss(CAL). Timepoint: before treatment, 1.5 and 3 months after treatment. Method of measurement: millimeter using williams plastic probe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Peri-implant bleeding after probing(BOP). Timepoint: before treatment, 1.5 and 3 months after treatment. Method of measurement: PBI index.</sec_outcome>
      <sec_outcome>Peri-implant gingival index(GI). Timepoint: before treatment, 1.5 and 3 months after treatment. Method of measurement: gingival index.</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>this study was self-funded by researchers.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-19</approval_date>
        <contact_name>Iran Islamic Azad university, Dental branch</contact_name>
        <contact_address>no 4, 10 th neyestan, pasdaran street tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
