<?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>IRCT20201110049346N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of combined low-level laser and piezocision versus each technique separately on canine retraction</public_title>
      <acronym></acronym>
      <scientific_title>Effects of combined low-level laser and piezocision versus each technique separately on canine retraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52264</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: In this study, random sequencing is done by restricted randomization method and since the equality of the two intervention groups is very important, the permuted block randomization subgroup is used.
Random allocation is concealed using opaque envelopes sealed in random sequence.
In this way, based on the sample size of the research, a number of non-transparent envelopes are prepared and each random sequence is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes is opened in order and its assigned group is identified.
Finally, due to the split mouth of the study method, each quadrant of the patient's maxilla is assigned to the control group or the intervention is done by  coin flipping (heads or tails).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Orthodontic patient with treatment plan for extraction of 4 maxillary teeth.</hc_freetext>
      <i_freetext>Intervention 1: The group prepared by piezocision surgery. 11 subjects were randomly selected and in each individual, a maxilla quadrant was randomly selected one week after extraction of the first maxillary premolars and 1-2 points in the area. Between the roots of teeth 3 and 5 are determined based on the amount of keratinized gums and inserted to a depth of 3 mm into the bone using a piezoelectric device (Acteon, CUBE, France) and piezocision surgery will be performed. The operation is performed only once.The type of movement considered is the movement of the canine tooth alone, so the connection of teeth 5 and 6 and the upper incisors will be done together and a vertical stop will be placed in front of tooth 6 to maintain anchorage. Standard canine retraction is performed on 17x25 stainless steel wires by applying standard forces of 150 g using force gauge (COREX, HAAG-STREIT, Switzerland) using elastomeric China (American Orthodontics, Sheboygan, WI, USA) short size.On the first day and weeks 3, 6 and 9, molding will be done to measure the amount of retraction. Intervention 2: Control group: The group prepared by the piezogen. Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides. Intervention 3: Intervention group: Laser irradiation group. 11 subjects were randomly selected and each maxillary quadrant was randomly selected one week after extraction of the first maxillary premolars. 810 nm laser radiation (dentaLase, QuickLase, Great Britain). ) With energy of 8 joules and power of 5 /. Watt will be performed for 16 seconds at 6 points on the buccal side and 6 points on the lingual side (two points on the cervical, two points on the middle region and two points on the apex) of the maxilla canine on the first day and weeks 3 and 6. The previous method is inserted and the molding is similar to the previous method. Intervention 4: control group: Laser radiation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides. Intervention 5: Intervention group: Combination group of laser radiation and piezocision operation.11 subjects were randomly selected and a maxillary quadrant in each individual was randomly selected one week after extraction of the first maxillary premolars.The piezocision operation and the first laser session are applied simultaneously on the selected side And wire and crease will be placed and molding will be done similar to the previous two methods. Intervention 6: Control group: Laser irradiation and piezocision operation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.</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 After confirming the code</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rayan Chaharmahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan.Dey avenue</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451766555</zip>
        <telephone>+98 61 3447 1049</telephone>
        <email>charmahali.r@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rayan Chaharmahli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan,dey avenue</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451766555</zip>
        <telephone>+98 61 3447 1049</telephone>
        <email>charmahali.r@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 15 to 25 years
Absence of any systemic disease and active periodontal disease
Need to extraction of the first premolars on both sides
NO  Previous orthodontic treatment
It has the normal shape and structure of the canine, the second premolar and the first maxillary molar</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The group prepared by piezocision surgery. 11 subjects were randomly selected and in each individual, a maxilla quadrant was randomly selected one week after extraction of the first maxillary premolars and 1-2 points in the area. Between the roots of teeth 3 and 5 are determined based on the amount of keratinized gums and inserted to a depth of 3 mm into the bone using a piezoelectric device (Acteon, CUBE, France) and piezocision surgery will be performed. The operation is performed only once.The type of movement considered is the movement of the canine tooth alone, so the connection of teeth 5 and 6 and the upper incisors will be done together and a vertical stop will be placed in front of tooth 6 to maintain anchorage. Standard canine retraction is performed on 17x25 stainless steel wires by applying standard forces of 150 g using force gauge (COREX, HAAG-STREIT, Switzerland) using elastomeric China (American Orthodontics, Sheboygan, WI, USA) short size.On the first day and weeks 3, 6 and 9, molding will be done to measure the amount of retraction.</i_keyword>
      <i_keyword>Control group: The group prepared by the piezogen. Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.</i_keyword>
      <i_keyword>Intervention group: Laser irradiation group. 11 subjects were randomly selected and each maxillary quadrant was randomly selected one week after extraction of the first maxillary premolars. 810 nm laser radiation (dentaLase, QuickLase, Great Britain). ) With energy of 8 joules and power of 5 /. Watt will be performed for 16 seconds at 6 points on the buccal side and 6 points on the lingual side (two points on the cervical, two points on the middle region and two points on the apex) of the maxilla canine on the first day and weeks 3 and 6. The previous method is inserted and the molding is similar to the previous method.</i_keyword>
      <i_keyword>control group: Laser radiation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.</i_keyword>
      <i_keyword>Intervention group: Combination group of laser radiation and piezocision operation.11 subjects were randomly selected and a maxillary quadrant in each individual was randomly selected one week after extraction of the first maxillary premolars.The piezocision operation and the first laser session are applied simultaneously on the selected side And wire and crease will be placed and molding will be done similar to the previous two methods.</i_keyword>
      <i_keyword>Control group: Laser irradiation and piezocision operation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Canine retraction rate in two maxillary quadrants using orthodontic piezo, laser and laser + piezo. Timepoint: In the samples of piezocision operation, measurements are made at the beginning of the study (before the intervention), 3, 6 and 9 weeks after the intervention on both control and operation sides (the  piezocision operation is performed only once.) In the sample Laser measurements are performed at the beginning of the study, at weeks 3, 6 and 9. (The laser is irradiated on the first day and weeks 3 and 6.) In the combination group, 2 measurement methods are similar to the previous two methods at the beginning, week 3, 6 and 9 are performed. (In this group, the  piezocision operation is performed once on the first day and the laser is irradiated on the first day and weeks 3 and 6). Method of measurement: Scan of casts at 3, 6 and 9 weeks and measuring the amount of movement compared to the initial time.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-19</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan. Khordad St., between Esfand St. and Iqbal St., Avisa Complex, Unit 5 Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
