<?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>IRCT20191113045428N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-19</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Aloe vera in periodontits</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of local application of Aloe vera gel as an non-surgical adjunctive treatment in patients with chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/43616</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The procedure will be split mouth in such a way that randomly with a pre-arranged randomization by random number table list half of the jaw is treated only with scaling and root planing and the other half with scaling and root planing with Topical use of aloe vera gel will be. After gel application, all treated areas will be covered with periodontal dressing for 24 hours. The purpose of periodontal dressing in the test areas is to prevent the saliva from gaining gel and in the control areas to blind the patient, Blinding description: The participant is kept blind as he does not know which quadrant of the jelly is placed because all the parts are put on periodontal dressing.The measuring clincian is kept blind and does not know where the gel is inserted when measuring the parameters.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic periodontitis is an inflammatory periodontal disease caused by the penetration of germs into the inflamed gums, resulting in periodontal tissue destruction and alveolar bone loss. Chronic periodontitis is the most common form of periodontitis..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth.That is, it will be randomly treated with a pre-made randomization list of half of a jaw under scaling and root planing with Aloe vera gel will be treated twice a week with topical application. Intervention 2: Control group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth. In the control group the other half of the jaw is treated only with scaling and root planing.In fact, the effectiveness of a substance is measured by each individual.</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 The study will be decided by the research team after the study is published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Vadoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916953358</zip>
        <telephone>+98 17 3255 0565</telephone>
        <email>Vadodi.sh@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ida Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental clinic, Edalat 97 Ave., Naharkhoran Blvd.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916953358</zip>
        <telephone>+98 17 3255 0565</telephone>
        <email>Drmirzaei.a@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being over 18 years old
Having at least 20 teeth in the mouth
Having at least one area with probing depth of 4 mm or more in at least two quadrants
Having at least one area of clinical attachment loss of 3 mm or more in at least two quadrants
Necessity to be available during the research process
Having informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of systemic disease affecting periodontal status
Sensitivity to aloe vera and its products
Receive systemic or topical antibiotic therapy in the past 3 months
Antioxidants intake of vitamin C or E in the past 3 months
Scaling and root planing treatment in the past 6 months
Smoking
Alcohol consumption
Pregnancy and lactation</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>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth.That is, it will be randomly treated with a pre-made randomization list of half of a jaw under scaling and root planing with Aloe vera gel will be treated twice a week with topical application.</i_keyword>
      <i_keyword>Control group: Before starting treatment, patients are subjected to the same hygiene training and are asked to use Orchid floss twice a day to clean interdental surfaces, followed by bass technique and Dr.West (soft) tooth brushing and toothpaste Merident Brush their teeth.A week later clinical parameters, measurements and treatment will begin.The procedure will be split mouth. In the control group the other half of the jaw is treated only with scaling and root planing.In fact, the effectiveness of a substance is measured by each individual</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Probing Pocket Depth. Timepoint: Before starting the study, 1 and 3 months later. Method of measurement: Distance of free gingival margin to base of gingival groove by periodontal probe Williams.</prim_outcome>
      <prim_outcome>Clinical Attachment Loss. Timepoint: Before starting the study, 1 and 3 months later. Method of measurement: Distance of Cemento Enamel Junction to base of gingival groove by periodontal probe Williams.</prim_outcome>
      <prim_outcome>Gingival Index. Timepoint: Before starting the study, 1 and 3 months later. Method of measurement: Specified number to determine the degree: Gingival Index0 (normal), Gingival Index1 (mild), Gingival Index2 (medium), Gingival Index3 (severe).</prim_outcome>
      <prim_outcome>Plaque Index. Timepoint: Before starting the study, 1 and 3 months later. Method of measurement: Percentage of adherent microbial plaque on tooth surface: Desirable: 0-30 Average: 31-50 Undesirable: 51-100.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-11</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Dental clinic, Edalat 97 Ave., Naharkhoran Blvd. Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
