<?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>IRCT20211114053062N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-12</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Diode Laser (940 nm) and Scalpel's Morbidity in Second Stage of Implant Surgeries</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Diode Laser (940 nm) and Scalpel's Morbidity in Second Stage of Implant Surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60126</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are entered into the study based on entry and exit criteria using available sampling and will be randomly assigned to one of the two control and intervention groups within each block using the random blocking method. The size of each block is equal. It will be with two, four or eight samples. After completing each block of treatments, people will be applied based on a random shift of treatments. Blocks and permutations within each block using the agricolae package (statistical procedure for agricultural research) in R software and using a specific seed (in computer concepts, in order to reproduce each random sequence, an optional number called seed is used). ) Will be created. The seed number allows the reproduction of a random sequence. Based on this package, the block number, block size, sequence within each block and the type of treatment of each person are provided as software output, Blinding description: For the patient, all surgical descriptions and complete information are given in written and oral form, ethically announced in the ethics committee and registered with the number IR.QUMS.REC.1400.218. They will be performed with full knowledge. In this study, patients have no information about the type of surgery they will receive. The surgery will be performed by a perio specialist and then the duration of the surgery will be recorded by an expert who does not know the type of surgery. Also, the healing rate of patients one week after surgery will be recorded by another specialist who does not know the type of surgery, and also for VAS.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The amount of pain and duration of surgery and tissue repair after surgery in the second stage..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Second stage surgery using a scalpel or 15c surgical scalpel, which is performed routinely and is not considered a new intervention. A circular incision is made on the top of the implant head and the healing abutment is ​​closed without the need for sutures. A circular incision with an approximate diameter of 2-3 mm is given on the soft tissue above the implant head with a razor number 15. Depending on the exact position of the implant, a circular incision is made later until the full cover screw appears and then healed. Abutment is connected. In the intervention group (diode laser), the second stage of implant surgery is performed using a 940 nm diode laser. The laser is used to create a small hole until a part of the screw cover appears. Then it is large enough to allow the screw to be removed, so the implant screw cover is removed and the abutment healer is connected. Intervention 2: Intervention group 2: Second stage surgery using 940 laser diode by the device (EPIC 10, biolase; as contact mode with maximum power 2.4 W with CP2 mode and E4 tip type). Creates a circular incision on the top of the implant head and closes the healing abutment without Need suture.</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 Because of personal privacy security of patients.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shabnam Sanayei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.14,Shahid Lashgari Blvd,Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415783783</zip>
        <telephone>0283337378</telephone>
        <email>drsanayeii@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shabnam sanayei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Lashgari Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415783783</zip>
        <telephone>0283337378</telephone>
        <email>drsanayeii@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>delayed loading dental implant
delayed insertion dental implant
two stage protocol of dental implant
healthy keratinized gingival tissues at least 3 mm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>failed dental implant
inflammation or peri-implant inflammation
radiolucent line around the dental implant</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Second stage surgery using a scalpel or 15c surgical scalpel, which is performed routinely and is not considered a new intervention. A circular incision is made on the top of the implant head and the healing abutment is ​​closed without the need for sutures. A circular incision with an approximate diameter of 2-3 mm is given on the soft tissue above the implant head with a razor number 15. Depending on the exact position of the implant, a circular incision is made later until the full cover screw appears and then healed. Abutment is connected. In the intervention group (diode laser), the second stage of implant surgery is performed using a 940 nm diode laser. The laser is used to create a small hole until a part of the screw cover appears. Then it is large enough to allow the screw to be removed, so the implant screw cover is removed and the abutment healer is connected.</i_keyword>
      <i_keyword>Intervention group 2: Second stage surgery using 940 laser diode by the device (EPIC 10, biolase; as contact mode with maximum power 2.4 W with CP2 mode and E4 tip type). Creates a circular incision on the top of the implant head and closes the healing abutment without Need suture.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain rate. Timepoint: Patients in both groups are called at 24 hours, 48 ​​hours and 72 hours after the second stage of implant surgery to be evaluated for pain (with Visual Analogue Scale). Method of measurement: Patients in both groups are called at 24 hours, 48 ​​hours and 72 hours after the second stage of implant surgery to be evaluated for pain (with Visual Analogue Scale).</prim_outcome>
      <prim_outcome>Duration of surgery. Timepoint: From the beginning of the laser to the end, from the beginning of the cut to the end. Method of measurement: From the beginning of the laser to the end, from the beginning of the cut to the end.</prim_outcome>
      <prim_outcome>Tissue repair. Timepoint: After 1 week, its amount in tissue repair (with wound healing index). Method of measurement: After 1 week, its amount in tissue repair (with wound healing index).</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>Qazvin University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-10</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin Shahid Bahonar Blvd.Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
