<?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>IRCT20151222025649N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-20</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effectiveness  pomegranate peel extract in treatment of gingival inflammation</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effectiveness of oral gel containing pomegranate peel extract in treatment of periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34172</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Drugs with A and B are named by the drug manufacturer, so that until the end of the study, she khows the pomegranate gel content or placebo for each tube A and B; In this way researcher and  statistical analysor will be blind. The patient have No information about the drug content will be placed on the study sites.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Moderate to severe chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The pomegranate peel extract gel in a periodontal pocket in a selected dental quadrant. After scalling all of the teeth  with a piezoelectroscopic device in a pre-selected pocket, the pomegranate gel is injected and the area is coverd with  coe-pack .the paitent asked to observe their oral health during the course of the study, but refrain from using dental floss and mouthwash in the studied area. Pomegranate and placebo gels produced in the pharmacy of Kermanshah University of Medical Sciences and they are absorbed by periodontal tissues after injection in periodontal pockets.The patient will be monitored for up to three months. The drug has polyphenol compounds such as gallic acid and is present at concentrations 15% and only 3-5ml in a periodontal envelope is injected. Intervention 2: Control group: The placebo in the periodontal pocket of another dental quadrant. This drug is similar to the pomegranate gel without any polyphenols.It is once and about 3-5 milligrams injected  in the periodontal pocket of another quadrant. Treatments are same as the intervention group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The total potential data after being unidentified is shared.

When:
Start the access, 6 months after printing the results

To whom:
All researchers can access the data

Conditions:
Using of data for use in other similar studies is warranted

Where to obtain:
School of Dentistry, Kermanshah University of Medical Sciences

How to obtain:
They can access information upon request from the Kermanshah University of Medical Sciences and receive confirmation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoome Eivazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite to the post office , Shariati Ave</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6713954658</zip>
        <telephone>+98 83 3722 2400</telephone>
        <email>m.eivazi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoome Eivazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite to the post office, Shariati Ave</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6713954658</zip>
        <telephone>+98 83 3722 2400</telephone>
        <email>m.eivazi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with chronic periodontitis that are healthy in terms of systemicity
No history of hypersensitivity</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receive other treatments
Tobacco and alcohol consumption
Pregnant and nursing women
Use of orthodontic appliance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The pomegranate peel extract gel in a periodontal pocket in a selected dental quadrant. After scalling all of the teeth  with a piezoelectroscopic device in a pre-selected pocket, the pomegranate gel is injected and the area is coverd with  coe-pack .the paitent asked to observe their oral health during the course of the study, but refrain from using dental floss and mouthwash in the studied area. Pomegranate and placebo gels produced in the pharmacy of Kermanshah University of Medical Sciences and they are absorbed by periodontal tissues after injection in periodontal pockets.The patient will be monitored for up to three months. The drug has polyphenol compounds such as gallic acid and is present at concentrations 15% and only 3-5ml in a periodontal envelope is injected.</i_keyword>
      <i_keyword>Control group: The placebo in the periodontal pocket of another dental quadrant. This drug is similar to the pomegranate gel without any polyphenols.It is once and about 3-5 milligrams injected  in the periodontal pocket of another quadrant. Treatments are same as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pocket depth. Timepoint: Before intervention, one month after intervention, three months after intervention. Method of measurement: Measuring the distance of pocket base to the gingival with periodontal probe.</prim_outcome>
      <prim_outcome>Clinical attachment loss. Timepoint: Before intervention, one month after intervention, three months after intervention. Method of measurement: Measuring the distance of base of pocket from CEJ.</prim_outcome>
      <prim_outcome>Gingival index. Timepoint: Before intervention, one month after intervention, three months after intervention. Method of measurement: Determination gingival inflammatory conditions based on observation and comparison.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: Before intervention, one month after intervention, three months after intervention. Method of measurement: Colored surfaces of tooth by disclosing agent.</prim_outcome>
      <prim_outcome>Bleeding index. Timepoint: Before intervention, one month after intervention, three months after intervention. Method of measurement: Determination of inflammatory conditions and gingival hemorrhage during probingwith periodontal probe.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-01</approval_date>
        <contact_name>Dentistry school of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Opposite of the Post office., Shariati Ave Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
