<?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>IRCT20240109060667N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-05</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evalution the effect of nanobioglass and diode laser (980 nm) in dentin hypersensitivity treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of nano bioglass and diode laser (980 nm) in dentin hypersensitivity treatment: a 6‐month clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74936</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>dentin hypersensivity.</hc_freetext>
      <i_freetext>Intervention 1: Control group: No laser or nanobio-glass were applied on dentin surfaces. Intervention 2: NB group (Nanobioglus): 50% solution of biogas nanoparticles and distilled water was prepared. Then, the ultrasonic probe with 20 kHz characteristics was homogenized for 20 seconds and 20 cycles of solution. Then, the solution was applied to dentin surfaces of teeth using an applicator brush for 20 seconds in two steps. Intervention 3: Intervention group:  Group L (laser): Diode laser with special radiation characteristics (wavelength 980 nm, power 3 watts, SSP mode, 5 mm non-contact), scanning in occlusopic and mesiodistal directions and vice versa with total radiation time of 21 min/cm2 on dentin surfaces of teeth. Intervention 4: Intervention group: Intervention group: nBL group (Nanobioglos + laser): The surfaces of the teeth were first prepared similar to the nB group and then they were applied to the same laser as group L. Intervention 5: Intervention group: Intervention group: LnB group (laser+nanobioglus): Diode liers were applied on the surfaces of teeth similar to group L and then similar to nB group Nanobioglus was applied.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I don't have any more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Blvd., Pajouhesh Sq., Hamedan, Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 917 758 5429</telephone>
        <email>sahel21975@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Blvd., Pajouhesh Sq., Hamedan, Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 917 758 5429</telephone>
        <email>sahel21975@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 No known allergy to commercial dental products
Teeth studied have no decay or repair
The patient has not previously received treatment for their dentinal allergy.
The patient should be able to determine the pain score in VAS in terms of age and mentality.
Patients should not have a history of receiving bleaching treatments by bleaching method.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with chronic diseases with episodes of daily pain who have taken anticonvulsants، analgesics ، antihistamines ، sedatives ، anti-inflammatory or analgesic drugs in the past 72 hours.
People who have used toothpaste or hypoallergenic mouthwashes in the past 3 months.
People who have had periodontal surgery in the past 6 months.
White bread teeth or white teeth that have cracks, previous repairs, caries lesions or active periodontal disease. Subjects with periodontal recession will remain active in the study.
People with deep cavities in the vicinity of sensitive teeth are likely to be mistaken for sensitive tooth pain.</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>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: No laser or nanobio-glass were applied on dentin surfaces.</i_keyword>
      <i_keyword>NB group (Nanobioglus): 50% solution of biogas nanoparticles and distilled water was prepared. Then, the ultrasonic probe with 20 kHz characteristics was homogenized for 20 seconds and 20 cycles of solution. Then, the solution was applied to dentin surfaces of teeth using an applicator brush for 20 seconds in two steps.</i_keyword>
      <i_keyword>Intervention group:  Group L (laser): Diode laser with special radiation characteristics (wavelength 980 nm, power 3 watts, SSP mode, 5 mm non-contact), scanning in occlusopic and mesiodistal directions and vice versa with total radiation time of 21 min/cm2 on dentin surfaces of teeth.</i_keyword>
      <i_keyword>Intervention group: Intervention group: nBL group (Nanobioglos + laser): The surfaces of the teeth were first prepared similar to the nB group and then they were applied to the same laser as group L.</i_keyword>
      <i_keyword>Intervention group: Intervention group: LnB group (laser+nanobioglus): Diode liers were applied on the surfaces of teeth similar to group L and then similar to nB group Nanobioglus was applied.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>People whose VAS scores are above 5. Timepoint: Patients were called for followup after 1 week, 1 month and 6 months after treatment. At each visit, the mentioned evaluation process was repeated for each patient and VAS score was recorded. Method of measurement: The lowest score is zero which means the situation is completely painless, and the highest score is 10, which means the maximum amount of pain that a person can experience.</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>Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-25</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., Pajoohesh Sq., Hamedan, Iran Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
