<?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>IRCT20100412003690N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-05</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effectiveness of the desensitizing Toothpastes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Nano Hydroxyapatite (n-HAP) with Potassium Nitrate (KNO3) in dental Hypersensitivity secondary to Periodontal Surgery in moderate to severe Periodontitis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling Method is randomly Available among Individuals referring to Periodontics Department of Tabriz Dental faculty. The randomization Method is simple and the Unit is individual, our Tool for randomization is the randomized Number Chart. Furthermore, the Allocation of Toothpastes to Patients is done Randomly. To do this, the types of the Toothpastes are identified with code A (Sensodyne) and B (Pharmed) and then the toothpastes are sealed in Envelopes that will be placed in a Box and stirred. Then they are randomly chosen from the Box and after observing the code, the Toothpaste is given to the Patient. None of the Patients will be informed about another Patient's Toothpaste. Operator who evaluating dental Hypersensitivity is not informed about Type of Toothpaste, Blinding description: Present Study is conducted in double-blinded fashion. Participants do not know that different types of Toothpastes are being studied. They are also totally blinded to the information of the other Participants. The Operator evaluating the dental Hypersensitivity will also be blinded to the types of the toothpastes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dental Hypersensitivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Those who receive Sensodyne Desensitizing  Toothpaste, which contains Potassium Nitrate; the Toothpaste will be applied topically. To do this, the sensitive Teeth will be covered for 2 minutes; at least 2 Times a Day for 1 Month with the toothpaste after placing it on the Toothbrush. Intervention 2: Intervention Group 2: Those who receive Pharmed Desensitizing  Toothpaste, which contains Potassium Nitrate; the Toothpaste will be applied topically. To do this, the sensitive Teeth will be covered for 2 minutes; at least 2 Times a Day for 1 Month with the toothpaste after placing it on the Toothbrush.</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 There is not more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Masoome Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor3, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>faramarzim@tbzmed.ac.ir</email>
        <affiliation>Periodontal and Dental Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masoome Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor3, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>faramarzim@tbzmed.ac.ir</email>
        <affiliation>Faculty of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the dental Hypersensitivity by an experienced Clinician
Gingival Retraction secondary to the periodontal Surgery
Presence of at least Three sensitive Teeth
Periodontal Conditions treated by periodontal Surgery</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to the Contents of the Toothpaste
Generalized Pathology in Oral Cavity
Systemic chronic Disease
Sensitive Teeth with Mobility higher than Grade 1
Sensitive Teeth with extent Restoration, Defect or prosthetic Crown
Sensitive Teeth suspected to Pulpitis, enamel Crack, Caries
Abutment Teeth of removeable partial Denture
People taking Antiepileptic, Antihistamine, Antidepressant, Antiinflamatory, Sedative Drugs or Analgesics
Pregnant and lactating Women
People who have Participated in similar Studies or have received any kind of Desensitizing Products in three months</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Those who receive Sensodyne Desensitizing  Toothpaste, which contains Potassium Nitrate; the Toothpaste will be applied topically. To do this, the sensitive Teeth will be covered for 2 minutes; at least 2 Times a Day for 1 Month with the toothpaste after placing it on the Toothbrush.</i_keyword>
      <i_keyword>Intervention Group 2: Those who receive Pharmed Desensitizing  Toothpaste, which contains Potassium Nitrate; the Toothpaste will be applied topically. To do this, the sensitive Teeth will be covered for 2 minutes; at least 2 Times a Day for 1 Month with the toothpaste after placing it on the Toothbrush.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Intensity of Pain in response to cold, hot and touch Stimulants. Timepoint: In the first Visit, 15 Days later and finally on the 30th Day. Method of measurement: 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-26</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Floor3, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
