<?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>IRCT20200727048216N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of adjunctive use of Nd:YAG laser in periodontal surgeries</public_title>
      <acronym></acronym>
      <scientific_title>Effect of adjunctive use of Nd:YAG laser in periodontal surgeries in patients with generalized moderate chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>17</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49974</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Prior to surgery, randomly selected quadrants (by taping or scribbling a coin) will be assigned to the control and experimental groups, Blinding description: Surgery will be performed by a periodontist and laser therapy will be performed by an oral medicine specialist. To measure blindness, measurements will be performed by a student under the supervision of a periodontist who is unaware of the treatment performed for the quadrants.</study_design>
      <phase>1</phase>
      <hc_freetext>Generalized moderate chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, the controlled OFD quadrant process will be performed first. Two weeks later, Nd: YAG laser radiation will be applied to the inner layer of the flap. The Nd: YAG laser with a wavelength of 1064 nm, an average efficiency of 4 w, energy per pulse of 80 mj, a diameter of 600 µm and a disposable fiber optic tip will be used to deliver energy to the area. The 4w medium-efficiency laser is placed in the pulse depth of the envelope, avoiding direct contact with the tooth or bone, by placing the fiber-optic tip in the pulse depth. The patient will receive routine antibiotic treatments. Finally, the distance between the cement and the enamel to the depth of the envelope, the depth of the probing, and the bleeding during the probing will be measured and compared. Intervention 2: Control group: The controlled OFD quadrant procedure will be performed first and the patient will receive routine antibiotic treatments after surgery. Finally, determining and comparing the distance between the joint of cement and enamel to the depth of the envelope, the depth of probing, bleeding during probing will be measured.</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>Hosein Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5969</telephone>
        <email>eslamihosein56@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5969</telephone>
        <email>eslamihosin56@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Generalized moderate chronic periodontitis
Willingness to participate in the study
Age between 20-55</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any systemic diseases and debilitating diseases that can affect a person's oral health
Any surgical and non-surgical periodontal treatments and antibiotic therapy performed during the last 6 months
Pregnancy
alcohol consumption
Tobacco use during the last three months
Taking anti-inflammatory drugs and antibiotics for the past three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the experimental group, the controlled OFD quadrant process will be performed first. Two weeks later, Nd: YAG laser radiation will be applied to the inner layer of the flap. The Nd: YAG laser with a wavelength of 1064 nm, an average efficiency of 4 w, energy per pulse of 80 mj, a diameter of 600 µm and a disposable fiber optic tip will be used to deliver energy to the area. The 4w medium-efficiency laser is placed in the pulse depth of the envelope, avoiding direct contact with the tooth or bone, by placing the fiber-optic tip in the pulse depth. The patient will receive routine antibiotic treatments. Finally, the distance between the cement and the enamel to the depth of the envelope, the depth of the probing, and the bleeding during the probing will be measured and compared.</i_keyword>
      <i_keyword>Control group: The controlled OFD quadrant procedure will be performed first and the patient will receive routine antibiotic treatments after surgery. Finally, determining and comparing the distance between the joint of cement and enamel to the depth of the envelope, the depth of probing, bleeding during probing will be measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical attachment loss. Timepoint: Start of study, 1 and 3 months after surgery. Method of measurement: Williams probes.</prim_outcome>
      <prim_outcome>Probing depth. Timepoint: Start of study, 1 and 3 months after surgery. Method of measurement: Williams probes.</prim_outcome>
      <prim_outcome>Bleeding on probing. Timepoint: Start of study, 1 and 3 months after surgery. Method of measurement: Williams probes.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-07</approval_date>
        <contact_name>Ethic committee of Tanriz University of Medical Sciences</contact_name>
        <contact_address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
