<?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>IRCT20180913041033N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-07</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>peri implant disease</public_title>
      <acronym>PI</acronym>
      <scientific_title>The effects of photo dynamic  therapy and nonsurgical mechanical debriment on pocket depth  and bleeding of probing in peri-implant disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33858</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 50 patients selected, half of them were randomly selected using the software and received photodynamic therapy.</study_design>
      <phase>3</phase>
      <hc_freetext>Peri-implantitis.</hc_freetext>
      <i_freetext>Intervention 1: control group::	 The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum. Intervention 2: Intervention group:  The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum فاثد.semi patients  treated with photodynamic therapy using Photosensitizer with a low-power diode laser (nm805, w5 / 0) using an inhaled cyanine green immediately after mechanical debridement.Photodynamic Therapy (PDT) is a new therapeutic method for the removal of infectious pathogens using photosensitizer and radiation with a specific length. PDT can be used locally in periodontal envelopes and prevent overhead associated with administration of systemic anti-microbial drugs. Slowly It also reduces the appearance of bacterial resistance.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is we consider  to check genetic of disease in order to precisely find the cause of disease</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Davood fathollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz, Vali Asr, Mossadegh Square, Eastern mikhak street, No. 60,floor. 6</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157967694</zip>
        <telephone>+98 41 3331 9677</telephone>
        <email>fathollahzadeh@tazmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davood fathollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz, Vali Asr, Mossadegh Square, Eastern mikhak street, No. 60,floor. 6</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157967694</zip>
        <telephone>+98 41 3331 9677</telephone>
        <email>Fathollahzadeh@tabzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria
bleeding of probing(bop)
Depth of probing greater than or equal to four millimeters
Under the implant's function for 1 year or more
Failure of recession soft tissue with or without a minimum bone recession  less than or equal to 2 mm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria
Pregnancy and lactation
Addicted to drugs and alcohol
Uncontrolled diabetes and disabling systemic disease
smokers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gingivitis and periodontal diseases</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>control group::	 The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum.</i_keyword>
      <i_keyword>Intervention group:  The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum فاثد.semi patients  treated with photodynamic therapy using Photosensitizer with a low-power diode laser (nm805, w5 / 0) using an inhaled cyanine green immediately after mechanical debridement.Photodynamic Therapy (PDT) is a new therapeutic method for the removal of infectious pathogens using photosensitizer and radiation with a specific length. PDT can be used locally in periodontal envelopes and prevent overhead associated with administration of systemic anti-microbial drugs. Slowly It also reduces the appearance of bacterial resistance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding on probing. Timepoint: Two weeks after mechanical and photodynamic therapy and at the end of the follow-up phase. Method of measurement: Bleeding on probing:The probe is carefully inserted into the pocket and slowly moves to the side of the implant and records bleeding if observed.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Suppuration. Timepoint: Baseline two weeks later, three months later. Method of measurement: The presence of (1) or loss of (0) by itself, after a probe or gingival pressure around the implant, Recorded with finger.</sec_outcome>
      <sec_outcome>Pain on Probing(POP). Timepoint: Baseline two weeks later, three months later. Method of measurement: How to measure pain using the Visual Analogue Scale (VAS) method: A ruler that is about ten centimeters in length is provided to the patient, and it is explained that if the pain is greatest in the entire length of the ruler and the lowest in the left end In this case, mark the amount of pain on the ruler. The distance from the marked point to the left is measured and reported in cm.</sec_outcome>
      <sec_outcome>Probing Depth (PD). Timepoint: Baseline two weeks later, three months later. Method of measurement: Depth of probe: In six points around the implants (Mesobuccal, Mid Buccal, Disto Buccal, Meso Lingual, Disto Lingual and Mid Lingual), the margin of the mucosa of the implant was measured to the depth of the gingival area with the probe and the deepest probe region was recorded as the probing depth.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-23</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences.</contact_name>
        <contact_address>Tabriz- Valiasr Coy; Mossadeq Square; Eastern Clove Coyote; No. 60, Floor 6 Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
