<?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>IRCT20201005048942N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-24</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of two wavelengths of 660 and 808 nm on chronic periodontitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two wavelengths of 660 and 808 nm as a low-level laser therapy on non-surgical periodontal  treatment in patients with chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>71</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51452</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected by Convenience sampling, but to select the studied quadrants and the type of wavelength, a random permutation pattern using a random number table will be used, Blinding description: Patient: Aware of laser radiation but does not know what wavelength each quadrant has received.
Periodontal specialist: Measures clinical parameters but does not know what wavelength each quadrant has received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) with a wavelength of 660 nm. Diode laser treatment is repeated 1, 3 and 7 days after the initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth. Intervention 2: Intervention group 2:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) is irradiated with a wavelength of 808 nm. Diode laser treatment is repeated at intervals of 1, 3 and 7 days after initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the main outcome can be shared.

When:
Since 1399

To whom:
Researchers working in academic and scientific institutions

Conditions:
There are no conditions.

Where to obtain:
estaji.f@goums.ac.ir

How to obtain:
There is no process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Reza Ahmadinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahriar 5 St., Shahriar Town, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۹۱۳۹۸۳۶۳۵</zip>
        <telephone>+98 17 3193 2173</telephone>
        <email>Ar.ahmadinia@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faezeh Estaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahmadi 11Ave., Abuzar 21 St.,Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918653885</zip>
        <telephone>+98 17 3244 0386</telephone>
        <email>estaji.f@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having chronic periodontitis with mmP-4-6 and CAL ≥3mm in maxillary premolars
People over 20 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any periodontal treatment has been performed in the last 6 months.
Use of antibiotics for the past 3 months for a week.
Existence of systemic diseases affecting periodontal tissue such as diabetes, cancer patients undergoing radiotherapy, malnutrition, zerostomia, hyperparathyroidism, hormonal diseases
Smoking, alcohol or other drugs.
Pregnancy and lactation.
The use of drugs that affect the periodontal tissue, such as immunosuppressive drugs, anticonvulsants, antihypertensives.
Patients with partial dentures.
Patients with fixed prostheses in premolars.
Teeth with grade 3 mobility.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis, unspecified</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:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) with a wavelength of 660 nm. Diode laser treatment is repeated 1, 3 and 7 days after the initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth.</i_keyword>
      <i_keyword>Intervention group 2:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) is irradiated with a wavelength of 808 nm. Diode laser treatment is repeated at intervals of 1, 3 and 7 days after initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinica attachment level ,Bleeding on probing, Gingival index, . Probing pocket depth. Timepoint: 1,3 and 6 month after treatment. Method of measurement: williams periodontal probe(Hu-Friedy,Chicago/USA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improving periodontal status and oral hygiene. Timepoint: 1, 3 and 6 months after treatment. Method of measurement: williams periodontal probe(Hu-Friedy,Chicago/USA).</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-30</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Shahriar 5, Shahriar Town,Gorgan Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
