<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034824</url>
  </required_header>
  <id_info>
    <org_study_id>JOP-16-0797</org_study_id>
    <nct_id>NCT03034824</nct_id>
  </id_info>
  <brief_title>Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels</brief_title>
  <official_title>Comparison Of Er,Cr:YSGG and Diode Laser on the Periodontal Parameters and Cytokines Levels in Patients With Generalized Aggressive Periodontitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and&#xD;
      tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical&#xD;
      periodontal parameters following the treatment with&#xD;
      Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to&#xD;
      scaling and root planing (SRP) in patients with generalized aggressive periodontitis (GAgP).&#xD;
      Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was designed as a&#xD;
      &quot;split-mouth&quot; study. In each patient, three quadrants were randomly determined as&#xD;
      SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were&#xD;
      recorded at the baseline and third month after the treatment. Cytokines levels in GCF were&#xD;
      determined by enzyme-linked immunosorbent assay (ELISA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 26 individuals were included in our study. Diagnoses were made after the clinical&#xD;
      and radiographic examinations on patients who applied to the Yuzuncu Yil University Faculty&#xD;
      of Dentistry, Department of Periodontology Clinics in 2014-2015. It was ensured that the&#xD;
      individuals who were included in the study did not have any systemic diseases; were not&#xD;
      menopausal, pregnant or lactating; had not used antibiotics or any other medication affecting&#xD;
      the immune system in the previous six months; were non-smokers; had at least 16 teeth in&#xD;
      their mouth; and had not received any periodontal treatment in the previous 6 months. The&#xD;
      subjects involved in the study were told the aim and content of the study by a clinician, and&#xD;
      they signed an approval form stating that they voluntarily participated in the survey. Each&#xD;
      individual read the Helsinki Declaration before joining the study. The Human Ethics Research&#xD;
      Committee of Yuzuncu Yil University (no.B.30.2.YYU.0.01.00.00/44-100912) gave the approval to&#xD;
      carry out the study.&#xD;
&#xD;
      The including criteria were applied in diagnosing generalized aggressive periodontitis&#xD;
      (International Workshop for Classification of Periodontal Diseases in 1999). Clinical&#xD;
      periodontal assessments, including periodontal status, were conducted by measuring the&#xD;
      bleeding on probing (BOP), plaque index (PI), gingival index (GI), probing pocket depth (PPD)&#xD;
      and clinical attachment level (CAL) at 6 sites per tooth by another clinician. The clinical&#xD;
      periodontal indices measured during the research were evaluated site-specifically by&#xD;
      including the mesial and distal of those teeth from which GCF samples were obtained.&#xD;
&#xD;
      All individuals received non-surgical initial periodontal treatment. At the baseline of the&#xD;
      study all quadrants were shown the similarity of periodontal disease. The procedures outlined&#xD;
      below were applied to all individuals in the study in randomly selected three different&#xD;
      quadrants. The study was designed as a &quot;split-mouth&quot; study.&#xD;
&#xD;
        1. Only SRP group (SRP-Control)&#xD;
&#xD;
        2. SRP+Er,Cr:YSGG laser group (SRP+Er,Cr:YSGG)&#xD;
&#xD;
        3. SRP+940±15 nm diode laser group (SRP+Diode) GCF sample sites were selected after probing&#xD;
           measurements were taken. The GCF samples were collected at the baseline of the study and&#xD;
           on the 3rd month following treatment. The GCF samples were taken from the deepest pocket&#xD;
           in all quadrants. The samples were collected with paper strips (Periopaper Oraflow,&#xD;
           NewYork, USA) that were cut in standard size. Before the sampling procedure,&#xD;
           supragingival plaque was removed and then the sites were isolated from saliva with&#xD;
           sterile buffer and sterile cotton rolls. The sampled tooth surfaces were dried by&#xD;
           slightly blowing air on them. The paper strips were inserted until a light resistance in&#xD;
           the sulcus was felt, and they were left there for 30 seconds. The strips that were&#xD;
           contaminated with blood were not included in the evaluation. The fluid amount was&#xD;
           measured by a Periotron device (Periotron 8000, Oraflow, NewYork, USA) and was converted&#xD;
           to GCF volume in ml units. The four strips which were obtained from every patient were&#xD;
           placed into individual Eppendorf tubes, each of which contained 500 μl of liquid&#xD;
           (Phosphate Buffer Saline (PBS)-pH 7.4) and a paper strip and were stored at -80o C.&#xD;
&#xD;
      SRP was first performed to the control quadrants of the individuals diagnosed with GAgP;&#xD;
      following the SRP procedure, the Er,Cr:YSGG laser was applied. The 940±15 nm diode laser was&#xD;
      applied prior to SRP, unlike the Er,Cr:YSGG laser (to prevent changing the diode laser&#xD;
      efficiency following bleeding). In the study, the Er,Cr:YSGG laser (Waterlase, Biolase,&#xD;
      Irvine, CA, USA) and the 940±15 nm diode laser (Ilase, Biolase, Irvine, CA, USA) were used.&#xD;
      For the Er,Cr:YSGG laser, a 14-mm Z-6 tip (600 μm fiberoptic tip, suitable for periodontal&#xD;
      use) marked to the depth of the pocket was used at a setting of 10 Hz, 1.5 W (150 mJ), 65%&#xD;
      air, 55% water with H mode, 140 μs pulse length. The total irradiation time was 30 s. The&#xD;
      940±15 nm diode laser with MZ6-14 mm standard tip was used at a setting in continuous wave&#xD;
      mode. The irradiation times for 940±15 nm diode laser were adjusted to 20 s.&#xD;
&#xD;
      The TNF-α, IL-1β and IL-8 analysis in GCF was conducted through the ELISA method by means of&#xD;
      commercial ELISA kits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal Clinical Indices</measure>
    <time_frame>1 year</time_frame>
    <description>Bleeding on probing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Clinical Indices</measure>
    <time_frame>1 year</time_frame>
    <description>Plaque index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Clinical Indices</measure>
    <time_frame>1 year</time_frame>
    <description>Gingival index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Clinical Indices</measure>
    <time_frame>1 year</time_frame>
    <description>Probing pocket depth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal Clinical Indices</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical attachment level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokines levels in gingival crevicular fluids</measure>
    <time_frame>1 year</time_frame>
    <description>Interleukin-1β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines levels in gingival crevicular fluids</measure>
    <time_frame>1 year</time_frame>
    <description>Interleukin-8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines levels in gingival crevicular fluids</measure>
    <time_frame>1 year</time_frame>
    <description>Tumor necrosis factor-α</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Aggressive Periodontitis</condition>
  <arm_group>
    <arm_group_label>Scaling and root planing (SRP)-Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only non-surgical initial periodontal treatment (scaling and root planing)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRP+940±15 nm diode laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRP+Er,Cr:YSGG laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SRP+940±15 nm diode laser</intervention_name>
    <description>In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.</description>
    <arm_group_label>SRP+940±15 nm diode laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SRP+Er,Cr:YSGG laser</intervention_name>
    <description>In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.</description>
    <arm_group_label>SRP+Er,Cr:YSGG laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing (SRP)-Control</intervention_name>
    <description>Only Non-surgical periodontal treatment</description>
    <arm_group_label>Scaling and root planing (SRP)-Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No systemic diseases&#xD;
&#xD;
          -  Not used antibiotics or any other medication affecting the immune system in the&#xD;
             previous six months&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Have at least 16 teeth in their mouth&#xD;
&#xD;
          -  Have not received any periodontal treatment in the previous 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 age&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmet C Talmac, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Researcher</affiliation>
  </overall_official>
  <results_reference>
    <citation>Hakki SS, Korkusuz P, Berk G, Dundar N, Saglam M, Bozkurt B, Purali N. Comparison of Er,Cr:YSGG laser and hand instrumentation on the attachment of periodontal ligament fibroblasts to periodontally diseased root surfaces: an in vitro study. J Periodontol. 2010 Aug;81(8):1216-25. doi: 10.1902/jop.2010.090715.</citation>
    <PMID>20476883</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Ahmet Cemil Talmac</investigator_full_name>
    <investigator_title>PhD, Dr. Dt.</investigator_title>
  </responsible_party>
  <keyword>diode laser</keyword>
  <keyword>Er,Cr:YSGG laser</keyword>
  <keyword>Aggressive Periodontitis</keyword>
  <keyword>Clinical periodontal parameters</keyword>
  <keyword>Gingival crevicular fluid cytokines levels</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Aggressive Periodontitis</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034824
org study id: JOP-16-0797
nct id: NCT03034824
lead sponsor: 
has dmc: No
The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and
      tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical
      periodontal parameters following the treatment with
      Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to
      scaling and root planing (SRP) in patients with generalized aggressive periodontitis (GAgP).
      Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was designed as a
      "split-mouth" study. In each patient, three quadrants were randomly determined as
      SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were
      recorded at the baseline and third month after the treatment. Cytokines levels in GCF were
      determined by enzyme-linked immunosorbent assay (ELISA).
A total of 26 individuals were included in our study. Diagnoses were made after the clinical
      and radiographic examinations on patients who applied to the Yuzuncu Yil University Faculty
      of Dentistry, Department of Periodontology Clinics in 2014-2015. It was ensured that the
      individuals who were included in the study did not have any systemic diseases; were not
      menopausal, pregnant or lactating; had not used antibiotics or any other medication affecting
      the immune system in the previous six months; were non-smokers; had at least 16 teeth in
      their mouth; and had not received any periodontal treatment in the previous 6 months. The
      subjects involved in the study were told the aim and content of the study by a clinician, and
      they signed an approval form stating that they voluntarily participated in the survey. Each
      individual read the Helsinki Declaration before joining the study. The Human Ethics Research
      Committee of Yuzuncu Yil University (no.B.30.2.YYU.0.01.00.00/44-100912) gave the approval to
      carry out the study.

      The including criteria were applied in diagnosing generalized aggressive periodontitis
      (International Workshop for Classification of Periodontal Diseases in 1999). Clinical
      periodontal assessments, including periodontal status, were conducted by measuring the
      bleeding on probing (BOP), plaque index (PI), gingival index (GI), probing pocket depth (PPD)
      and clinical attachment level (CAL) at 6 sites per tooth by another clinician. The clinical
      periodontal indices measured during the research were evaluated site-specifically by
      including the mesial and distal of those teeth from which GCF samples were obtained.

      All individuals received non-surgical initial periodontal treatment. At the baseline of the
      study all quadrants were shown the similarity of periodontal disease. The procedures outlined
      below were applied to all individuals in the study in randomly selected three different
      quadrants. The study was designed as a "split-mouth" study.

        1. Only SRP group (SRP-Control)

        2. SRP+Er,Cr:YSGG laser group (SRP+Er,Cr:YSGG)

        3. SRP+940±15 nm diode laser group (SRP+Diode) GCF sample sites were selected after probing
           measurements were taken. The GCF samples were collected at the baseline of the study and
           on the 3rd month following treatment. The GCF samples were taken from the deepest pocket
           in all quadrants. The samples were collected with paper strips (Periopaper Oraflow,
           NewYork, USA) that were cut in standard size. Before the sampling procedure,
           supragingival plaque was removed and then the sites were isolated from saliva with
           sterile buffer and sterile cotton rolls. The sampled tooth surfaces were dried by
           slightly blowing air on them. The paper strips were inserted until a light resistance in
           the sulcus was felt, and they were left there for 30 seconds. The strips that were
           contaminated with blood were not included in the evaluation. The fluid amount was
           measured by a Periotron device (Periotron 8000, Oraflow, NewYork, USA) and was converted
           to GCF volume in ml units. The four strips which were obtained from every patient were
           placed into individual Eppendorf tubes, each of which contained 500 μl of liquid
           (Phosphate Buffer Saline (PBS)-pH 7.4) and a paper strip and were stored at -80o C.

      SRP was first performed to the control quadrants of the individuals diagnosed with GAgP;
      following the SRP procedure, the Er,Cr:YSGG laser was applied. The 940±15 nm diode laser was
      applied prior to SRP, unlike the Er,Cr:YSGG laser (to prevent changing the diode laser
      efficiency following bleeding). In the study, the Er,Cr:YSGG laser (Waterlase, Biolase,
      Irvine, CA, USA) and the 940±15 nm diode laser (Ilase, Biolase, Irvine, CA, USA) were used.
      For the Er,Cr:YSGG laser, a 14-mm Z-6 tip (600 μm fiberoptic tip, suitable for periodontal
      use) marked to the depth of the pocket was used at a setting of 10 Hz, 1.5 W (150 mJ), 65%
      air, 55% water with H mode, 140 μs pulse length. The total irradiation time was 30 s. The
      940±15 nm diode laser with MZ6-14 mm standard tip was used at a setting in continuous wave
      mode. The irradiation times for 940±15 nm diode laser were adjusted to 20 s.

      The TNF-α, IL-1β and IL-8 analysis in GCF was conducted through the ELISA method by means of
      commercial ELISA kits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Periodontal Clinical Indices
time frame: 1 year
description: Bleeding on probing
measure: Periodontal Clinical Indices
time frame: 1 year
description: Plaque index
measure: Periodontal Clinical Indices
time frame: 1 year
description: Gingival index
measure: Periodontal Clinical Indices
time frame: 1 year
description: Probing pocket depth
measure: Periodontal Clinical Indices
time frame: 1 year
description: Clinical attachment level
measure: Cytokines levels in gingival crevicular fluids
time frame: 1 year
description: Interleukin-1β
measure: Cytokines levels in gingival crevicular fluids
time frame: 1 year
description: Interleukin-8
measure: Cytokines levels in gingival crevicular fluids
time frame: 1 year
description: Tumor necrosis factor-α
arm group label: Scaling and root planing (SRP)-Control
arm group type: Experimental
description: Only non-surgical initial periodontal treatment (scaling and root planing)
arm group label: SRP+940±15 nm diode laser
arm group type: Experimental
description: In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser
arm group label: SRP+Er,Cr:YSGG laser
arm group type: Experimental
description: In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser
intervention type: Procedure
intervention name: SRP+940±15 nm diode laser
description: In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.
arm group label: SRP+940±15 nm diode laser
intervention type: Procedure
intervention name: SRP+Er,Cr:YSGG laser
description: In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.
arm group label: SRP+Er,Cr:YSGG laser
intervention type: Procedure
intervention name: Scaling and root planing (SRP)-Control
description: Only Non-surgical periodontal treatment
arm group label: Scaling and root planing (SRP)-Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: No
last name: Ahmet C Talmac, PhD
role: Principal Investigator
affiliation: Researcher
citation: Hakki SS, Korkusuz P, Berk G, Dundar N, Saglam M, Bozkurt B, Purali N. Comparison of Er,Cr:YSGG laser and hand instrumentation on the attachment of periodontal ligament fibroblasts to periodontally diseased root surfaces: an in vitro study. J Periodontol. 2010 Aug;81(8):1216-25. doi: 10.1902/jop.2010.090715.
PMID: 20476883
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Ahmet Cemil Talmac
investigator title: PhD, Dr. Dt.
mesh term: Periodontitis
mesh term: Aggressive Periodontitis
mesh term: Aggression
sharing ipd: No