<?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>IRCT20201219049759N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-28</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Combined Diode Laser and GLUMA Bonding Therapy with Combined Diode Laser and 5% Sodium Fluoride Varnish in Patients with Increased Dentin Sensitivity</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Combined Diode Laser and GLUMA Bonding Therapy with Combined Diode Laser and 5% Sodium Fluoride Varnish in Patients with Increased Dentin Sensitivity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization by roll a dice method. This method is used for multi-group studies. Numbers 1 and 2 were considered for the first group, numbers 3 and 4 were considered for the second group, and numbers 5 and 6 were considered for the third group, Blinding description: Patients did not know how to treat each of the teeth included in the study, and laser eye goggles were used for all patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Increased dentin sensitivity. Condition 2: diode laser. Condition 3: GLUMA bonding. Condition 4: 5% Sodium Fluoride Varnish.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (bonding): For this purpose, we use the solution of Kulzer GmbH, Germany GLUMA Desensitizer, which in a 5 ml bottle contains 5% glutaraldehyde, 35% HEMA-G and distilled water. One drop of the solution with a applicator is placed on the desired tooth for 30 seconds. It is then dried with a stream of air until the liquid layer on the tooth disappears and its surface loses its luster. Intervention 2: Intervention group (laser): For this purpose, a KONFTEC Corporation Taiwan KONFTEC Klas-DX diode laser device is used. The laser is applied to the surface of the affected tooth for 30 seconds from the buccal side and 30 seconds from the lingual side with a wavelength of 660 nm and a power of 15 mW using caps D and E, depending on the size of the tooth. The densities in these two caps are 1.8 and 6.9 J / cm2 respectively. Intervention 3: Intervention group (varnish): On the buccal and lingual surface of the target tooth is covered with a microbrush of 5% sodium fluoride solution (Asia Fluoride Chemical Chemistry, Iran). The patient will then be instructed to abstain from eating and drinking for up to one hour after the intervention and to brush for up to 12 hours. Intervention 4: Control group: In each patient, an insensitive tooth is randomly considered as a control.</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>Fahimeh Anbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Evin, Shahid Chamran Highway, Daneshjoo Blvd., Shahid Beheshti University of Medical Sciences, 97 / 5000 Translation results School of Dentistry</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>098 21 22175351</telephone>
        <email>fahimeh.anbari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Anbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Shahid Chamran Highway, Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2217 5351</telephone>
        <email>fahimeh.anbari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>good general health
Having at least 3 teeth with hypersensitivity to contact stimulus or air blast
Agree to follow up for 1 month</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having benign or malignant oral disease
long-term use of the drug
having caries in the affected or adjacent tooth
enamel cracking
congenital defects in the enamel or dentin
tooth restoration
orthodontic procedures
periodontal disease
history of vital bleaching
history of Periodontal surgery or treatment of hypersensitivity during the last 6 months
history of non-surgical treatment of periodontal disease during the past 3 months
use of mouthwash containing allergens
pregnancy or lactation
use of antidepressants and analgesics
history of allergies to components Various treatment therapies
bruxism
abrasion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (bonding): For this purpose, we use the solution of Kulzer GmbH, Germany GLUMA Desensitizer, which in a 5 ml bottle contains 5% glutaraldehyde, 35% HEMA-G and distilled water. One drop of the solution with a applicator is placed on the desired tooth for 30 seconds. It is then dried with a stream of air until the liquid layer on the tooth disappears and its surface loses its luster.</i_keyword>
      <i_keyword>Intervention group (laser): For this purpose, a KONFTEC Corporation Taiwan KONFTEC Klas-DX diode laser device is used. The laser is applied to the surface of the affected tooth for 30 seconds from the buccal side and 30 seconds from the lingual side with a wavelength of 660 nm and a power of 15 mW using caps D and E, depending on the size of the tooth. The densities in these two caps are 1.8 and 6.9 J / cm2 respectively.</i_keyword>
      <i_keyword>Intervention group (varnish): On the buccal and lingual surface of the target tooth is covered with a microbrush of 5% sodium fluoride solution (Asia Fluoride Chemical Chemistry, Iran). The patient will then be instructed to abstain from eating and drinking for up to one hour after the intervention and to brush for up to 12 hours.</i_keyword>
      <i_keyword>Control group: In each patient, an insensitive tooth is randomly considered as a control.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity on the VAS scale. Timepoint: Before the intervention, immediately after the intervention and at intervals of 2, 7 days and 1 month after the intervention. Method of measurement: VAS 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-14</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Highway, Velenjak St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
