<?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>IRCT201311103690N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of minocycline and emdogain in the treatment of peri-implant mucosal inflammation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the microbiological effects of sustain released microspherical minocycline and emdogain in the non-surgical treatment of peri-implant mucosal inflammation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will be randomly assigned to receive one of treatment protocols. The allocation sequence will be concealed from the examiner, patients and statistical analyzers. Staff members who obtain the results will not be aware how the study groups are assigned. Moreover the intervention staff, who delivered the intervention will not also be given the results. Therefore, the final results will not be revealed to any of the investigators, staff, or participants.</study_design>
      <phase>2</phase>
      <hc_freetext>mocusal inflammation around dental implants.</hc_freetext>
      <i_freetext>Intervention 1: Control: Instruction of oral hygiene and debridement of subgingival environment using ultrasonic scaler and glycine-based powder air polishing. Intervention 2: Intervention 1 : Two weeks after mechanical debridement, one mg of minocycline hydrochloride microspheres (Arestin OraPharma, Inc USA) will be located subgingivally in the affected sites around the implant. Intervention 3: Intervention 2 : Two weeks after mechanical debridement, 0.1 ml of Enamel Matrix Derivative Gel (Emdogain) 0.3 ml straumann will be located subgingivally in the affected sites around the implant with the help of syringe.</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>Zahra Goharfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614713</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>zgoharfar61@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences, Faculty of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Faramarzie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614713</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>faramarzim@tbzmed.ac.ir</email>
        <affiliation>Faculty of Dentistry, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 - Adults aged 18 years and older&#13;
 - Patients with peri-implant inflammation, defined as: Presence of bleeding on probing, probing depth more than 4mm, lack of soft tissue recession, radio-graphic bone loss less than 2mm.&#13;
 - Implant functioning for at least one year&#13;
    Exclusion criteria:&#13;
 - Taking systemic or local antibiotics in the past 3 months&#13;
 - Regular intake of anti-inflammatory drugs in the past 3 months  &#13;
 - Any intervention for treatment of peri-implant inflammation in the past 3 months&#13;
 - Poor oral hygiene&#13;
 - Smoking&#13;
 - Long term treatment with any medication that affects soft and hard tissue conditions (such as phenytoin, cyclosporin, calcium canal blockers...) &#13;
 - Pregnancy and lactation&#13;
 - Sever periodontal disease&#13;
 - Uncontrolled diabetes or debilitating systemic disease&#13;
 - Drug and alcohol addiction&#13;
 - Allergy to tetracycline-class drug(s)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A41.5, A41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sepsis due to anaerobes, Sepsis due to other Gram-negative organisms</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control: Instruction of oral hygiene and debridement of subgingival environment using ultrasonic scaler and glycine-based powder air polishing.</i_keyword>
      <i_keyword>Intervention 1 : Two weeks after mechanical debridement, one mg of minocycline hydrochloride microspheres (Arestin OraPharma, Inc USA) will be located subgingivally in the affected sites around the implant.</i_keyword>
      <i_keyword>Intervention 2 : Two weeks after mechanical debridement, 0.1 ml of Enamel Matrix Derivative Gel (Emdogain) 0.3 ml straumann will be located subgingivally in the affected sites around the implant with the help of syringe.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Numbers of the porphyromonas gingivalis bacteria. Timepoint: Before intervention, 2 weeks and 3 months after intervention. Method of measurement: The number of bacteria with polymerase chain reaction (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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-23</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, Iran Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
