<?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>IRCT20200126046260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-13</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of low level laser therapy on pain perception</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Prophylactic low level laser therapy on pain perception due to infiltration injection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is simple and individual.
Randomization technique: covariate adaptive randomization, Blinding description: Patients are unaware of which side of the mouth is under laser prophylaxis.When using diode laser we also put the device in silent mode.The light is also not visible due to the direct contact of the laser probe with the mucosal surface.</study_design>
      <phase>3</phase>
      <hc_freetext>The effect of laser therapy on injection pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study will be done by split mouth method. The purpose of split mouth study is to eliminate all variables related to different individuals. In Split Mouth method, buccal injection will be done on both sides of maxilla, so that injection will be done in two sessions separately, once in control side and once in test side. The priming of the injection and determination of the experimental and control side will be randomly selected by Covariate adaptive randomization.  Both techniques are used for each patient, lidocaine local anesthetic gel with one laser and local anesthetic gel alone on the other. Half of the participants are randomly selected (Covariate adaptive randomization) to First apply the local anesthetic gel with the laser on one side and then the gel alone on the other side of their mouth. This protocol is performed for the other half of participants in reverse. On the control side, the buccal mucosa of the canine tooth is dried with a cotton roll for 30 seconds, then topical lidocaine anesthesia gel is applied for one minute. Immediately using a powered off laser. used for 1 minute to create a placebo effect. On the test side, the buccal mucosa of the canine similar to anesthetic gel was applied for one minute and then laser irradiated at 940 nm before being injected for one minute.Then a short needle (gauge 27) is used by the dentist for injection. The injection will be done by ICT Injection. ICT Injection is a device that performs injection at a constant and adjustable speed and pressure. The device has three stages of injection, respectively, at speeds (1.8 ml / 250,150.50 s) and constant pressure. After preparation of the injection site, the device will be injected with the C-K Ject needle as follows: Initially 5 sec at 1.8 ml / 250 s in stage 1, then 5 sec at 1.8 ml / 150 s in stage 2 and in the remaining carpal anesthesia at 1.8 ml / 50 s in stage 3. Be.Patients in this study will be anesthetized with 2% Lidocaine plus Lidocaine 1% 8000 2% E-80, Darou Pakhsh, Karaj, Iran). Intervention 2: Control group: At the control side, the buccal mucosa of the canine tooth is dried with cotton roll for 30 seconds, then topical lidocaine anesthesia gel is applied for one minute. This process is immediately followed by silent laser application for 1 minute to produce a placebo effect and then The injection is done in the same way.</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 is shared after unidentifying patients.

When:
Start of access period 6 months after printing results.

To whom:
Data and other documentation will be available to researchers and other prospective data seekers.

Conditions:
All scientific and practical uses of this data are permitted.

Where to obtain:
via E-mail: zandi9574@gmail.com

How to obtain:
You will receive a reply within a week after the request is sent to the above email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shakiba Zandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij sq.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3526</telephone>
        <email>zandi9574@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shakiba Zandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij sq.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3526</telephone>
        <email>zandi9574@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 20-27 years
candidate for bilateral canine anesthesia</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>27 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has lost the canine tooth on one or both sides.
The patient's age is outside the age range specified.
The patient is taking painkillers or sedatives.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain, not elsewhere classified</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: This study will be done by split mouth method. The purpose of split mouth study is to eliminate all variables related to different individuals. In Split Mouth method, buccal injection will be done on both sides of maxilla, so that injection will be done in two sessions separately, once in control side and once in test side. The priming of the injection and determination of the experimental and control side will be randomly selected by Covariate adaptive randomization.  Both techniques are used for each patient, lidocaine local anesthetic gel with one laser and local anesthetic gel alone on the other. Half of the participants are randomly selected (Covariate adaptive randomization) to First apply the local anesthetic gel with the laser on one side and then the gel alone on the other side of their mouth. This protocol is performed for the other half of participants in reverse. On the control side, the buccal mucosa of the canine tooth is dried with a cotton roll for 30 seconds, then topical lidocaine anesthesia gel is applied for one minute. Immediately using a powered off laser. used for 1 minute to create a placebo effect. On the test side, the buccal mucosa of the canine similar to anesthetic gel was applied for one minute and then laser irradiated at 940 nm before being injected for one minute.Then a short needle (gauge 27) is used by the dentist for injection. The injection will be done by ICT Injection. ICT Injection is a device that performs injection at a constant and adjustable speed and pressure. The device has three stages of injection, respectively, at speeds (1.8 ml / 250,150.50 s) and constant pressure. After preparation of the injection site, the device will be injected with the C-K Ject needle as follows: Initially 5 sec at 1.8 ml / 250 s in stage 1, then 5 sec at 1.8 ml / 150 s in stage 2 and in the remaining carpal anesthesia at 1.8 ml / 50 s in stage 3. Be.Patients in this study will be anesthetized with 2% Lidocaine plus Lidocaine 1% 8000 2% E-80, Darou Pakhsh, Karaj, Iran).</i_keyword>
      <i_keyword>Control group: At the control side, the buccal mucosa of the canine tooth is dried with cotton roll for 30 seconds, then topical lidocaine anesthesia gel is applied for one minute. This process is immediately followed by silent laser application for 1 minute to produce a placebo effect and then The injection is done in the same way.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain perception. Timepoint: 5 seconds after starting the injection. Method of measurement: Visual Analog Scale -Faces Pain Rating Scale-Sound Eye motor pain-physiologic scale of pain and stress.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>NO.39,Manoochehri St.,Esfahan Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
