<?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>IRCT20220607055098N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of root canal disinfection by 980nm Diode laser on post operative pain after single visit root canal treatment of first and second maxillary molars</public_title>
      <acronym></acronym>
      <scientific_title>Effect of root canal disinfection by 980nm Diode laser on post operative pain after single visit root canal treatment of first and second maxillary molars: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is balanced block.
The randomization unit of each molar tooth belongs to each single patient and only one molar tooth from each patient is included in the study.
The randomization tool uses a table of printed random numbers, the odd digit of group A and the even digit of group B until the intervention in the block is filled, and then the results are recorded in the order of registration and allocation of each sample inside the sealed envelope, which at the time of the intervention The envelope will be opened.
The way to make a random sequence is based on the sequence of people's referrals.
The person who determines the type of random allocation of samples is the consultant of methodology and statistics of the study, who leaves the sealed envelopes at the disposal of the clinical researcher and has no role in the clinical research process. The envelopes remain sealed until the intervention and are opened in the order mentioned on the back of the envelope, Blinding description: The steps of both groups are the same. In both the laser and placebo groups, the tips will be inserted into the canal to the working length , but in the placebo group the lasers will not be activated and only the disinfection steps by laser will be simulated. Before the operation, the two groups will be explained to the patients and all the patients will be told that you are not aware of the treatment group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>نکروز پالپی.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Laser : After preparation of the canal, the laser radiation will be performed by a 980 nm diode laser in the root canal. Irradiation will be performed in 4 pulses, each pulse is laser radiation for 5 seconds and then stops for 10 seconds. The movement speed of the tip is 2 mm/s and the location of the tip is 1 mm above the apex. It will be performed with a power of 1.2 watts, and the tips with a diameter of 200 microns and a length of 15 mm go into the canal until the working length, and the laser is irradiated by rotation and then exits the channel. Intervention 2: Control group: Similar to the laser group, tips will be inserted into the canal but won't be activated and the steps will be simulated.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All potential data can be shared after the participants are unidentifiable.

When:
Access period starts from 2024.

To whom:
Only for researchers working in academic and scientific institutions.

Conditions:
The data can be used for scientific researches.

Where to obtain:
Saba Rai
Sabarai12@gmail.com

How to obtain:
After submitting the request, the request will be reviewed and answered as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saba Rai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Zamin Tower, Bakhshi Alley, Khovardin Blvd, Shahrake-Gharb Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1465953541</zip>
        <telephone>+98 21 8857 7243</telephone>
        <email>sabarai12@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 9th Neyestan, Pasdaran Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All the patients must have pulp necrosis of maxillary molar.
Patients must be between 18 to 50 years old.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have taken antibiotics in the month before the intervention.
Patients taking analgesia 12 hours before the intervention.
Teeth that have already undergone endodontic treatment.
Patients who have acute pain at the time of intervention.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Necrosis of pulp</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Laser : After preparation of the canal, the laser radiation will be performed by a 980 nm diode laser in the root canal. Irradiation will be performed in 4 pulses, each pulse is laser radiation for 5 seconds and then stops for 10 seconds. The movement speed of the tip is 2 mm/s and the location of the tip is 1 mm above the apex. It will be performed with a power of 1.2 watts, and the tips with a diameter of 200 microns and a length of 15 mm go into the canal until the working length, and the laser is irradiated by rotation and then exits the channel.</i_keyword>
      <i_keyword>Control group: Similar to the laser group, tips will be inserted into the canal but won't be activated and the steps will be simulated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain after endodontic treatment. Timepoint: Immediately after treatment, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment. Method of measurement: 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-21</approval_date>
        <contact_name>کمیته اخلاق دانشکده دندانپزشکی، دانشگاه علوم پزشکی آزاد اسلامی تهران</contact_name>
        <contact_address>No. 9, 9th Neyestan, Pasdaran Avenue Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
