<?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>IRCT20180630040290N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of coenzyme Q10 supplement on chronic gingivitis inflammation in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supplementation of Q10 coenzyme with Scaling and root planing (SRP) on periodontal and gingival indexes in controled diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49867</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method is randomly available among individuals referring to periodontics department of Tabriz dental faculty. The randomization method is simple and the unit is individual, our tool for randomization is the randomized number chart. Furthermore, the allocation of traetment to patients is done randomly. To do this, the types of the traetment are identified with code A (Q10 coenzyme with Scaling and root planing (SRP)) and B (SPR) and then the traetment are sealed in envelopes that will be placed in a box and stirred. Then they are randomly chosen from the box and after observing the code, the traetment is given to the patient. None of the patients will be informed about another patient's traetment. The a evaluater will olso be is not informed about type of traetment, Blinding description: The present study is one-way blind and the a evaluater will olso be is not informed about type of traetment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Controlled diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Coenzyme Q10 will be administered with SRP for 30 days, after which periodontal and gingival index values ​​will be measured. Patients were randomly divided into two groups and will given 200 mg of coenzyme Q10 or placebo daily for 30 days. For all patients, coenzyme Q10 prescription and oral hygiene training and accurate SRP will performe by a therapist in a one-hour session.  For this purpose, hand tools, ultrasonic and rubber cap and pumice paste will be used. Intervention 2: Control group: The SRP will be prescribed for 30 days and then relating to periodontal and jinjal indicators will be measured.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic patients referred to the periodontitis Department of Tabriz Dental School
Having informed consent
Having age 29 to 59</inclusion_criteria>
      <agemin>29 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with systemic disease
Pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus with other specified complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Coenzyme Q10 will be administered with SRP for 30 days, after which periodontal and gingival index values ​​will be measured. Patients were randomly divided into two groups and will given 200 mg of coenzyme Q10 or placebo daily for 30 days. For all patients, coenzyme Q10 prescription and oral hygiene training and accurate SRP will performe by a therapist in a one-hour session.  For this purpose, hand tools, ultrasonic and rubber cap and pumice paste will be used.</i_keyword>
      <i_keyword>Control group: The SRP will be prescribed for 30 days and then relating to periodontal and jinjal indicators will be measured</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pocket Depth. Timepoint: Before the intervention , one months after initiating the intervention. Method of measurement: A periodontal probe is used to measure this parameter.  The first sign visible at the top of the envelope is the depth of the envelope.</prim_outcome>
      <prim_outcome>Clinical Attachment Level. Timepoint: Before the intervention , one months after initiating the intervention. Method of measurement: The clinical adhesion of the gums is obtained by the difference between the distance from the gingival margin to the plaque floor from the CEJ distance to the gingival margin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plaque index. Timepoint: Before the intervention , one months after initiating the intervention. Method of measurement: Plaque index is obtained from dividing the number of levels with plaque on the total number of multiplication levels in 100 .</sec_outcome>
      <sec_outcome>Bleeding index. Timepoint: Before the intervention , one months after initiating the intervention. Method of measurement: Bleeding index (BI) is measured using the University of North Carolina probe_15 (UNC-15) probe.</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>2020-07-20</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
