<?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>IRCT20190422043343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-19</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Different Desensitiser Protocols on Dentin Hypersensitivity Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Effect of  Fluoride Varnish, Gluma and Er: Cr: YSGG Laser on dentin hypersensitivity in patients with sensitive teeth: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39153</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, participants are classified according to their initial sensitivity and then randomly divided into random classes in a randomized block to ensure that each group is in the same state of origin in terms of initial sensitivity. Block size and randomization method will be determined by another person Other than the therapists and evaluators. Given the fact that the stimulus air flow is effective in evaluating the effectiveness of the therapeutic methods compared to the adjacent teeth, only one treatment will be used in each jaw quadrant, Blinding description: This study is a double-blind study. One operator irradiate laser and apply densitisers , while the other operator will assess the sensitivity. Also, patients will not be aware of the treatment they will receive and on the teeth Patients whose therapeutic protocol does not include lasers will be targeted by the aiming beam.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Dentin hypersensivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:laser: Laser Er, Cr: YSGG (Waterlase, Biolase Technology, Irvine, CA) perpendicular to the dentin surface by moving scanning movements at a distance of 1 mm with zero percent of air and water for 30 seconds with a frequency of 20 Hz and a power of 0.25 W (44.3J / cm2) whit M Z6 sapphire tip with a diameter of 600 micron and a length of 6 mm will be exposed on the sensitive teeth. Intervention 2: Intervention group 2 (fluoride varnish):A cotton roll for isolating the environment and preventing the varnish mix with saliva will be used. Then, a thin layer of  Fluoride varnish (Ivoclar Vivadent), will be applied on the surface of the tooth with a disposable microbrush in accordance with the factory's instructions. Two to three layers of varnish will be applied to the surface of the teeth on the same day. Patients will be told to stop taking any food or carbonate drink for an hour after using varnish. Intervention 3: Intervention group 3 (fluoride varnish and laser): The varnish will be used similarly to the method used in group 2 on the teeth surface, and the varnish will remain in place for 60 seconds, and then the laser will be exposed with the same radiant profile of the group 1 on its surface. Intervention 4: Intervention group 4 (Gluma): A cotton roll for rubbing the Gluma (Heraeus Kulzer GmbH, Hanau, Germany) will be used with a gentle but firm motion on the tooth surface. After 30 to 60 seconds, the dentin will dry completely until The fluid will disappear and the surface will lose its gloss state. Intervention 5: Intervention group 5 (Gluma and laser): The Gluma will be used similar to that used in group 4 on the teeth surface. then, the laser will be exposed with the same radiant profile of the group 1 on its surface.</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 Due to the confidentiality of patient information, the decision to publish the participant information file has not yet been finalized.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Forouzande</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmide</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516647447</zip>
        <telephone>+98 81 3838 6410</telephone>
        <email>mahsaforouzande@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Loghman Rezaie Soufi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmide</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516647447</zip>
        <telephone>+98 81 3838 6410</telephone>
        <email>loghmansoufi@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Good general health without any known allergies to commercial dental products
The teeth do not have any decay or restoration
The patient has not previously received any treatment for dentin hypersensitivity
The patient has the ability to determine the pain score in the VAS in terms of age and mentality
Patients do not have a history of receiving bleaching treatments</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with chronic disease with daily episodes of pain that use analgesics, antihistamines, anti-inflammatory drugs, or analgesics during the last 72 hours
People who have used toothpaste or antisensivity mouthwash for the last 3 months.
People who have had periodontal surgeries in the last 6 months.
non vital teeth or vital teeth with crack, previous restoration, decay lesions, or active periodontal disease. patients without active periodontal disease will remain active in the study
People with deep carries adjacent to a sensitive tooth that have a chance of confusing pain with sensitive tooth pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified diseases of hard tissues of teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:laser: Laser Er, Cr: YSGG (Waterlase, Biolase Technology, Irvine, CA) perpendicular to the dentin surface by moving scanning movements at a distance of 1 mm with zero percent of air and water for 30 seconds with a frequency of 20 Hz and a power of 0.25 W (44.3J / cm2) whit M Z6 sapphire tip with a diameter of 600 micron and a length of 6 mm will be exposed on the sensitive teeth.</i_keyword>
      <i_keyword>Intervention group 2 (fluoride varnish):A cotton roll for isolating the environment and preventing the varnish mix with saliva will be used. Then, a thin layer of  Fluoride varnish (Ivoclar Vivadent), will be applied on the surface of the tooth with a disposable microbrush in accordance with the factory's instructions. Two to three layers of varnish will be applied to the surface of the teeth on the same day. Patients will be told to stop taking any food or carbonate drink for an hour after using varnish.</i_keyword>
      <i_keyword>Intervention group 3 (fluoride varnish and laser): The varnish will be used similarly to the method used in group 2 on the teeth surface, and the varnish will remain in place for 60 seconds, and then the laser will be exposed with the same radiant profile of the group 1 on its surface.</i_keyword>
      <i_keyword>Intervention group 4 (Gluma): A cotton roll for rubbing the Gluma (Heraeus Kulzer GmbH, Hanau, Germany) will be used with a gentle but firm motion on the tooth surface. After 30 to 60 seconds, the dentin will dry completely until The fluid will disappear and the surface will lose its gloss state.</i_keyword>
      <i_keyword>Intervention group 5 (Gluma and laser): The Gluma will be used similar to that used in group 4 on the teeth surface. then, the laser will be exposed with the same radiant profile of the group 1 on its surface.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tooth sensitivity amount. Timepoint: After 1 week, 1 month and 6 months. Method of measurement: VAS score.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-05</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
