<?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>IRCT20120901010703N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-24</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative evaluation of the effect of Gluma Desensitizer and high power 980-nm Diode Laser and combination of them on reduction of dentin hypersensitivity</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the effect of Gluma Desensitizer and high power  Diode Laser 980-nm and combination use of them on reduction of dentin hypersensitivity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the number of available groups (4 groups for intervention and control), there are papers with the group name written on them and placed in a box. Each sample person picks  a paper from the box and receives the desired treatment, Blinding description: The data analyzer and patient do not know the type of received treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Dentin hypersensitivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention group 1 treatment with gluma desensitizer from Kulzer Company.gluma desensitizer apply on dry teeth 60 seconds and dry for 5 secondes. Intervention 2: Intervention group: intervention group 2 treatment with laser diode 980 nm (1 watt,980 nm) distance from tooth 1mm duration 30 seconds. Intervention 3: Intervention group: intervention group 3 treatment with combination of gluma desensitizer and followed by laser diode 980 nm . gluma desensitizer apply on dry tooth 60 seconds and dried for 5 seconds then diode laser (1 watt ,980nm) apply on tooth with distance 1mm for 30 seconds. Intervention 4: Control group: control group treatment without gluma desensitizer and apply only conductor light  of laser (off laser set) and with SRP on patients.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Naghsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental faculty, Isfahan University of Medical Sciences, Hezarjerib street</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2870</telephone>
        <email>n_naghsh@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>narges naghsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezarjrib street</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5564</telephone>
        <email>n_naghsh@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referred to the general and specialized periodontics department of Isfahan Dental School have  3 teeth with complaints of cervical dentin sensitivity and sensitivity to cold stimuli that are not adjacent to each other. Patients should be available for three months during the study period and sign the informed consent form .Teeth do not need restorative treatment People over 18 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Caries, crack and pulpitis,  Existence of active caries, cervically restored teeth, coronary fractures .Pregnant and lactating people smoking Patients  and who have used anti-sensitive toothpaste and other medicines for the past 6 months. bleaching in past 6 months,  diet (use of sour and acidic foods), People who have high O'leary index in follow up sessions (higher than 25%)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.89</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 - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention group 1 treatment with gluma desensitizer from Kulzer Company.gluma desensitizer apply on dry teeth 60 seconds and dry for 5 secondes.</i_keyword>
      <i_keyword>Intervention group: intervention group 2 treatment with laser diode 980 nm (1 watt,980 nm) distance from tooth 1mm duration 30 seconds</i_keyword>
      <i_keyword>Intervention group: intervention group 3 treatment with combination of gluma desensitizer and followed by laser diode 980 nm . gluma desensitizer apply on dry tooth 60 seconds and dried for 5 seconds then diode laser (1 watt ,980nm) apply on tooth with distance 1mm for 30 seconds.</i_keyword>
      <i_keyword>Control group: control group treatment without gluma desensitizer and apply only conductor light  of laser (off laser set) and with SRP on patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of patient's pain (dentin hypersensitivity). Timepoint: Before treatment, 15 minutes after treatment in the first session, one week after the first session, two weeks after the first session, one month after the first session, tree months after the first session. Method of measurement: Use of cold spray, use of air syringe of unit.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-13</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology; Building No. 4; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St., isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
