<?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>IRCT20220205053946N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-09</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Influence of postoperative  low-level laser therapy on crestal bone levels around dental implants</public_title>
      <acronym></acronym>
      <scientific_title>Influence of postoperative low-level laser therapy using laser diode 940 nm on crestal bone levels around dental implants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>9</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61766</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: People participating in the study are aware of the laser treatment, but they are not aware of the quadrant that the jaw is radiated.
The oral and maxillofacial surgeon that performs implant treatment is not aware of the quadrant that the jaw is radiated.
People who Evaluate the outcomes (student and the oral and maxillofacial radiologist) are not aware of the quadrant that the jaw is radiated.
People who analyze the data ( Statistical specialist) is not aware of the quadrant that the jaw is radiated.
Only the oral and teeth specialist who performs laser treatment will be aware of  the quadrant that the jaw is radiated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>loss of teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An implant is placed on each side on opposite sides of a jaw in the same area, and immediately, using the split-mouth method, with a low-power 940 nm diode laser with a power output of 0.5 watts with 6 j/cm2 energy density in 6 areas around one implant of one side of the jaw (control side), radiation is received. For blinding, the laser tube is placed on both sides, but only on one side of the laser will radiate. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All surgeries are performed by an experienced surgeon with the same technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All laser treatments are performed by an experienced specialist with the same technique. All patients use the same antibiotics and painkillers. Intervention 2: Control group: The control group is actually the sides of the patients' jaw that is not exposed to the laser beam. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All patients use the same antibiotics and painkillers.</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>Dr. Ehsan Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No2, Hepko Ave, Navab ST, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817979438</zip>
        <telephone>+98 86 3369 1355</telephone>
        <email>momeni8384@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ehsan Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2, Hepko Ave, Navab ST, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817979438</zip>
        <telephone>+98 86 3369 1355</telephone>
        <email>momeni8384@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The applicants of implant treatment that two-sided in a jaw in a similar area have lost tooth. tooth extraction at least 6 months before implant surgery; nongrafted implant site; type 2 or 3 bone quality according to the Lekholm and Zarb classification, adequate space with buccolingual width of minimum 6 mm and mesiodistal width of minimum 7 mm; inter-occlusal distance greater than 7 mm.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women. Any mental illness and psychological and behavioral conditions, which is the absolute contraction of implant treatment. Any systemic illness that contraindicates surgery; uncontrolled diabetes mellitus; bisphosphonate therapy; history of radiotherapy in the maxillofacial region within last 12 months; smoking; para-functional habits; poor oral hygiene with full mouth plaque score and full mouth bleeding score ≥25%, periodontally compromised patients with attachment loss ≥3 mm, and/or radiographic bone loss ≥30% of root length in ≥30% of sites and those who refused to return for follow-up were excluded from this study.</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>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An implant is placed on each side on opposite sides of a jaw in the same area, and immediately, using the split-mouth method, with a low-power 940 nm diode laser with a power output of 0.5 watts with 6 j/cm2 energy density in 6 areas around one implant of one side of the jaw (control side), radiation is received. For blinding, the laser tube is placed on both sides, but only on one side of the laser will radiate. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All surgeries are performed by an experienced surgeon with the same technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All laser treatments are performed by an experienced specialist with the same technique. All patients use the same antibiotics and painkillers.</i_keyword>
      <i_keyword>Control group: The control group is actually the sides of the patients' jaw that is not exposed to the laser beam. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All patients use the same antibiotics and painkillers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring crestal bone levels around dental implants by radiography. Timepoint: Crestal bone level at 4 time 1) immediately after receiving of 940 nm (T0) laser (T0) 2) 6 weeks after receiving laser diode 940 nm (T1) 3) 6 months after receiving low-laser diode 940 nm (T2) Using parallel-based digital periametic radiography, measured by parallel technique. Method of measurement: Using parallel-based digital periametic radiography, measured by parallel technique.</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>2021-12-26</approval_date>
        <contact_name>Ethics committee Arak University of Medical Sciences</contact_name>
        <contact_address>No.30, Shahid Shiroudi Ave, Alam-o-Alhoha ST, Arak, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
