<?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>IRCT20170210032484N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-11</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effect of used home bleaching on gingival health in 18 to 30 years</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effect of used dental  bleaching carbamide peroxide 16% gel  on gingival health in 18 to 30 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29510</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Effect of Carbamide peroxide on Gingival health.</hc_freetext>
      <i_freetext>patients ,Before starting treatmen:, the required explanations about stages of treatment will be provided to patients and written consent will be obtained The dates of the attendance of the participants in the various meetings will be given in writing to them.In order to improve the oral health condition, a soft toothbrush and identical toothpastes and floss will be given to each patient. The same technique of brushing (Bass technique) and the same way of flossing will be trained (3 times a day for brushing teeth at correct times, noon and night, and floss once a night); and They should refrain from using other oral hygiene products.Patients will be required to refrain from eating any colorful drinks, such as tea, coffee, Nescafé, and wine during the bleaching process.At this stage, gingival health indicators including sulcus bleeding index and gingival index and plaque index will be measured For each patient a prophylaxis is performed with oil-free prophylactic paste in order to omit the foreign pigments (by the student). Each patient will receive Alginate templates (by the student) and after confirming the template's correctness by the supervisor, chalk cast is immediately prepared after molding (by the student). The patient is notified about the next appointment.Physical surfaces of teeth is excluded in gypsum casts with a distance of 0.5 mm from gingival margin to ensisal block (it is done by the library technician).In next appointment, patient’s special tray is tested in his mouth and checked in relation to accordance with the teeth and gum margin. If not complied, it is made again. Maintenance training of the tray is presented during treatment. Bleaching tube jell is carbamaid proxide 16% (whiteness perfect (FGM Dental- products , Joinville, Sc, brazil).The tube jell is given to each patient the same day with its applying. instructions. The time to apply is 4 hours a day in tray until 14 days. The instructions are presented both orally and in writing.                                  all of this patients after treatment :The patient refers back after 14 days and SBI and PI and GI measured again.and compared with data of before treatment..</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 study not completion</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad javad Asgharzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98167-43463</zip>
        <telephone>+98 54 1341 6708</telephone>
        <email>mjasgharzadehfirstjarobahs@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Tabatabayie Somaye</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan Str</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98176-43463</zip>
        <telephone>+98 54 1341 6708</telephone>
        <email>somayehtabatabaei@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Non-smokers
Women aged 18-30 years
With natural anterior teeth with A2, B2, C2, D2 colors and darker (Vitapan Classic Shade)
Minimum of 24 teeth
Suitable oral hygiene
Patient Satisfaction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People tooth decay
People with Gingivitis and periodontal diseases
People  tooth root spreading
People  cervical lesions NCCL (Non Caries Cervical Lesions)
People who do  have Ortho treatment
pregnant and lactating women
Lack of calculus
People  bleach treatment history in the past
Individuals changing the colors caused by fluorosis and tetracycline
any anterior restoration</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T49.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Poisoning by, adverse effect of and underdosing of dental drugs, topically applied</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>patients ,Before starting treatmen:, the required explanations about stages of treatment will be provided to patients and written consent will be obtained The dates of the attendance of the participants in the various meetings will be given in writing to them.In order to improve the oral health condition, a soft toothbrush and identical toothpastes and floss will be given to each patient. The same technique of brushing (Bass technique) and the same way of flossing will be trained (3 times a day for brushing teeth at correct times, noon and night, and floss once a night); and They should refrain from using other oral hygiene products.Patients will be required to refrain from eating any colorful drinks, such as tea, coffee, Nescafé, and wine during the bleaching process.At this stage, gingival health indicators including sulcus bleeding index and gingival index and plaque index will be measured For each patient a prophylaxis is performed with oil-free prophylactic paste in order to omit the foreign pigments (by the student). Each patient will receive Alginate templates (by the student) and after confirming the template's correctness by the supervisor, chalk cast is immediately prepared after molding (by the student). The patient is notified about the next appointment.Physical surfaces of teeth is excluded in gypsum casts with a distance of 0.5 mm from gingival margin to ensisal block (it is done by the library technician).In next appointment, patient’s special tray is tested in his mouth and checked in relation to accordance with the teeth and gum margin. If not complied, it is made again. Maintenance training of the tray is presented during treatment. Bleaching tube jell is carbamaid proxide 16% (whiteness perfect (FGM Dental- products , Joinville, Sc, brazil).The tube jell is given to each patient the same day with its applying. instructions. The time to apply is 4 hours a day in tray until 14 days. The instructions are presented both orally and in writing.                                  all of this patients after treatment :The patient refers back after 14 days and SBI and PI and GI measured again.and compared with data of before treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gingival index. Timepoint: 1to 14 days after start bleaching. Method of measurement: Clinical examination of gingival health index.</prim_outcome>
      <prim_outcome>Sulcus bleeding index. Timepoint: 1to 14 days after start bleaching. Method of measurement: Probing.</prim_outcome>
      <prim_outcome>Plaque index. Timepoint: 1to 14 days after start bleaching. Method of measurement: Disclosing agent.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-28</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>West Azadegan , Khoramshahr Blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
