<?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>IRCT20201106049289N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-06</date_registration>
      <primary_sponsor>Bandarabbas university of medical sciences</primary_sponsor>
      <public_title>The effect of anaheal tablet after flap removal pocket surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of anaheal tablet after flap removal pocket surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done simply by tossing coins and participants will be divided into two intervention groups and a control group, Blinding description: The patient receives the drug (intervention or comparison group) in sealed packets that are coded. The coding is done by one of the project partners and the dentist and the patient are blind.</study_design>
      <phase>2</phase>
      <hc_freetext>Periodontal disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then, 500 mg of Anahil capsules is given twice a day, one hour before a meal, after surgery. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods. Intervention 2: Control group:  Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then the second pill or capsule is given twice a day after surgery, one hour before a meal. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods.</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 ..</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hossein Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Street</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 3280</telephone>
        <email>Babazadeh@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Street</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 3280</telephone>
        <email>Babazadeh@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with chronic periodontitis who need envelope removal surgery after completing phase I periodontitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a systemic disease
 Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Periodontal disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then, 500 mg of Anahil capsules is given twice a day, one hour before a meal, after surgery. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods.</i_keyword>
      <i_keyword>Control group:  Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then the second pill or capsule is given twice a day after surgery, one hour before a meal. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BOP values. Timepoint: Before therapeutic intervention and one month after the intervention. Method of measurement: BOP: Each tooth is probed on four levels: mesial, distal, buccal and lingual. Insert the probe gently and gently to the depth of the envelope and remove it. positive and otherwise considered BOP negative.</prim_outcome>
      <prim_outcome>GI score PI index plate score. Timepoint: Measurement is performed at baseline, one week after surgery and 4 weeks after surgery. Method of measurement: Using the percentage of painted surfaces of teeth after using detectors.</prim_outcome>
      <prim_outcome>Depth of Probe. Timepoint: Before therapeutic intervention and one month after the intervention. Method of measurement: Using the percentage of painted surfaces of teeth after using detectors.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Removal pocket. Timepoint: Periodontal indices will be re-measured in both groups before, four weeks and eight weeks after surgery. Method of measurement: GI , PI  and BOP indices will be measured according to the standard methods of articles.</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>Bandarabbas university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Street Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
