<?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>IRCT20120702010155N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-15</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  Aloe vera gel on wound healing following gingival surgery</public_title>
      <acronym></acronym>
      <scientific_title>Effect of using Aloe vera gel on wound healing following periodontal flap surgery (clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients with odd ID are treated right side and patient whit even ID are treated left side, Blinding description: Since the aloe vera gel is mixed with the dressing and inserted after surgery, the patient is not aware of the use of aloe vera. On the other hand, the researcher is a non-surgical surgeon and has no knowledge of the gel used in the area.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Periodontosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Aloe vera gel in one side of the patient's jaw is put with periodontal dressing. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after  surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception). Intervention 2: Control group: On the opposite side of the patient's jaw, periodontal dressing is inserted without aloe vera gel. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after  surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception).</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 we will decide based on the results of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Taghi Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>mtchitsazi@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Taghi Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>mtchitsazi@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient with indication of widman flap</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Antibiotic use history up to 6 months
The presence of a systemic disease that affects the periodontal condition
Taking medication or having conditions that affect the periodontal condition
Smoking
Aggressive Periodontitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Periodontosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Aloe vera gel in one side of the patient's jaw is put with periodontal dressing. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after  surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception).</i_keyword>
      <i_keyword>Control group: On the opposite side of the patient's jaw, periodontal dressing is inserted without aloe vera gel. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after  surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 3, 7, 14 days after surgery. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Gingival color. Timepoint: 7, 14 days after surgery. Method of measurement: visual (Red, coral pink, dark pink).</prim_outcome>
      <prim_outcome>Granulation tissue. Timepoint: 7, 14 days after surgery. Method of measurement: Visual (less than 2 mm mild, more than 2 mm severe).</prim_outcome>
      <prim_outcome>Gingival consistency. Timepoint: 7, 14 days after surgery. Method of measurement: periodontal prob.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-10</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
