<?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>IRCT20221212056791N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Nano-emodin on palatal wound healing</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the photodynamic therapy with Nano-emodin on palatal wound healing after free gingival graft; a parallel clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After graft harvesting, the patient was randomly assigned into one of the three groups of treatment using a randomization software.
 Random allocation, patient enrolment, and assignment was done by different clinicians.
An epidemiologist who was not aware of the treatment modalities generated the random allocation sequence using a computerized block randomization process, Blinding description: To be blind, the examiners were asked to comment only on the final outcome and then their comments were recorded. Statistical analysis was done in three groups A, B and C so that the analyzer is blind to the results. A placebo gel was used in the control group to make the patient blind.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Evaluation of palatal wound healing after free gingival graft surgery due to lack of attached gingiva.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface. Intervention 2: Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface along with LED radiation for 1 minute. Intervention 3: Control group: Placing placebo gel without LED radiation.</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:
Gathered data will be analyzed and then published.

When:
It will be determined after the article is published.

To whom:
Everyone (depending on the journal policies)

Conditions:
Published article will be public.

Where to obtain:
The journal that the paper is published in.

How to obtain:
Just sending Email to corresponding author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Isaabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nirogah, Tawheed Square, Javadalameh St., No. 161, 5th Alley</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3717896519</zip>
        <telephone>+98 25 3891 0857</telephone>
        <email>mahdi.isa2758@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak yaghobee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>At the end of North Kargar Street, befor Hakim Highway, Tehran Faculty of Dentistry and Medical Sciences, Periodontics Department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>009842794000</telephone>
        <email>s_yaghobee@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients age ≥ 18 years.
systemically healthy.
The graft dimensions were taken with a maximum width of ten millimeters and a length of fifteen to twenty-five millimeters.
Patients should sign the informed consent form to participate in the study after receiving sufficient information about the risks, advantages and disadvantages.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active gag reflux.
Smoking and alcohol consumption, periodontal diseases, traumatic occlusion
systemic diseases considered either as the contra-indications of periodontal surgeries or in contradiction with wound healing process such as diabetes and history of treatment with high dose steroids
taking anti-coagulation medications, radiotherapy or other types of therapies suppressing the immunity system, pregnancy, breast-feeding, digestive disorders.
a history of taking medications distorting the wound healing process or inducing gingival enlargement.
the patients missing the follow-up sessions after the surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface</i_keyword>
      <i_keyword>Intervention group: Placing a gel containing 10% Nano-Emodin for 5 minutes on the wound surface along with LED radiation for 1 minute</i_keyword>
      <i_keyword>Control group: Placing placebo gel without LED radiation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The clinical effect of photodynamic therapy using Nano-Emodin on the palatal wound healing after free gingival graft surgery. Timepoint: Comparison of the average area of the remaining wound in the palate at intervals of 7, 14, 21 and 28 days after surgery. Comparison of the amount of bleeding after surgery in the first 7 days. Comparison of the degree of color matching and epithelialization in the time interval 7, 14, 21, 28. Comparison of the average index of pain and discomfort in the first 10 days after surgery. Method of measurement: The average area of the remaining wound in the area by image j program. Comparison of the amount of bleeding through a questionnaire. Comparison of color matching with Adobe Photoshop software. Examining the amount of epithelialization through 3% hydrogen peroxide. Index of pain and discomfort using Visual Analogue Scale.</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>medical University Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-05</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>At the end of North Kargar Street, before Hakim Highway, Faculty of Dentistry Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
