<?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>IRCT20221210056769N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of 940-nm Diode on Periodontal Conditions</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of 940-nm Diode Laser Effectiveness on Pocket Depth, Clinical Attachment Level and Bleeding on Probing in Chronic Periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67318</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first session, supragingival scaling of the whole mouth and hygiene education is performed, and then clinical parameters including pocket depth (PD), clinical attachment loss (CAL), and bleeding on probing (BOP) are measured in 6 points of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) and recorded in the corresponding form. It should be noted that the accuracy of the examiner's assessment will be checked and confirmed in several test sessions and cases under the supervision of a periodontist. Then, subgingival scaling and root planing (SRP) is performed under local anesthesia by a periodontist with a valid laser fellowship. Subsequently, one of the two left or right sides is chosen randomly by tossing a coin for the adjunctive laser treatment, and by the same periodontist undergoes laser therapy with the protocol approved by the Laser Center of RWTH University of Aachen, Germany. On the SRP side, the tip of the laser fiber is moved without being activated, similar to the method performed on the SRP+L side, so the patient does not know which side has undergone laser therapy. A week later, laser therapy is repeated without performing SRP according to the above method. It should be noted that the person responsible for measuring clinical parameters will not be aware of the laser-treated side, Blinding description: On the SRP side, the tip of the laser fiber is moved without being activated, similar to the method performed on the SRP+L side, so the patient does not know which side has undergone laser therapy. A week later, laser therapy is repeated without performing SRP according to the above method. It should be noted that the person responsible for measuring clinical parameters will not be aware of the laser-treated side.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: scaling and root planing (SRP) of the selected teeth. Intervention 2: . Intervention 3: Intervention group: 980nm diode laser therapy of the selected teeth following the scaling and root planing (SRP).</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Ebrahim Seyed-Monir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan University of Medical Sciences International Campus Faculty, 30 meters Blvd., Bandar Anzali</address>
        <city>Bandar Anzali</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>43146-37758</zip>
        <telephone>+98 13 4455 3185</telephone>
        <email>seyedmonir.ali13@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Ebrahim Seyed-Monir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan University of Medical Sciences International Campus Faculty, 30 meters Blvd, Bandar Anzali</address>
        <city>Bandar Anzali</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>43146-37758</zip>
        <telephone>+98 13 4455 3185</telephone>
        <email>seyedmonir.ali13@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients receiving no periodontal treatments during the last 12 months
No antibiotic consumption during the last 3 months
Absence of any systematic disease (i.e. diabetes) affecting the process of periodontal treatment
No anti-inflammatory drug consumption during the last 3 months
No pregnancy
No oral contraceptive pills consumption
No smoking or drug addiction
No need for antibiotic prophylaxis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discontinuing the treatment procedure by the patient
Becoming affected by a disease that requires medical therapy during the investigation period</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></i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: scaling and root planing (SRP) of the selected teeth</i_keyword>
      <i_keyword></i_keyword>
      <i_keyword>Intervention group: 980nm diode laser therapy of the selected teeth following the scaling and root planing (SRP)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparative assessment of periodontal pocket depth after treatment in the case and control groups. Timepoint: 3 months. Method of measurement: Using a scaled periodontal probe, the distance between the gingival wall and the tooth surface from the gingival margin to the uppermost part of the junctional epithelium is measured and recorded.</prim_outcome>
      <prim_outcome>Comparative assessment of clinical attachment loss (CAL) after treatment in the case and control groups. Timepoint: 3 months. Method of measurement: Using a scaled periodontal probe, the distance between the border of the enamel and cementum (Cemento-Enamel Junction) to the depth of the pocket is measured and recorded.</prim_outcome>
      <prim_outcome>Comparative assessment of bleeding on probing (BOP) after treatment in the case and control groups. Timepoint: 3 months. Method of measurement: Checking the presence or absence of blood leakage 30 seconds after probing the periodontal pocket.</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>Personal by the researcher</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-16</approval_date>
        <contact_name>Research Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Dentistry Faculty, Guilan University of Medical Sciences, Fuman-Saravan Road Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
