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Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels

Primary Purpose

Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SRP+940±15 nm diode laser
SRP+Er,Cr:YSGG laser
Scaling and root planing (SRP)-Control
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aggressive Periodontitis focused on measuring diode laser, Er,Cr:YSGG laser, Aggressive Periodontitis, Clinical periodontal parameters, Gingival crevicular fluid cytokines levels

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No systemic diseases
  • Not used antibiotics or any other medication affecting the immune system in the previous six months
  • Non-smokers
  • Have at least 16 teeth in their mouth
  • Have not received any periodontal treatment in the previous 6 months

Exclusion Criteria:

  • Under 18 age
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Scaling and root planing (SRP)-Control

    SRP+940±15 nm diode laser

    SRP+Er,Cr:YSGG laser

    Arm Description

    Only non-surgical initial periodontal treatment (scaling and root planing)

    In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser

    In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser

    Outcomes

    Primary Outcome Measures

    Periodontal Clinical Indices
    Bleeding on probing
    Periodontal Clinical Indices
    Plaque index
    Periodontal Clinical Indices
    Gingival index
    Periodontal Clinical Indices
    Probing pocket depth
    Periodontal Clinical Indices
    Clinical attachment level

    Secondary Outcome Measures

    Cytokines levels in gingival crevicular fluids
    Interleukin-1β
    Cytokines levels in gingival crevicular fluids
    Interleukin-8
    Cytokines levels in gingival crevicular fluids
    Tumor necrosis factor-α

    Full Information

    First Posted
    December 21, 2016
    Last Updated
    February 22, 2017
    Sponsor
    Yuzuncu Yıl University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03034824
    Brief Title
    Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels
    Official Title
    Comparison Of Er,Cr:YSGG and Diode Laser on the Periodontal Parameters and Cytokines Levels in Patients With Generalized Aggressive Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yuzuncu Yıl University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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. Only SRP group (SRP-Control) SRP+Er,Cr:YSGG laser group (SRP+Er,Cr:YSGG) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aggressive Periodontitis
    Keywords
    diode laser, Er,Cr:YSGG laser, Aggressive Periodontitis, Clinical periodontal parameters, Gingival crevicular fluid cytokines levels

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scaling and root planing (SRP)-Control
    Arm Type
    Experimental
    Arm Description
    Only non-surgical initial periodontal treatment (scaling and root planing)
    Arm Title
    SRP+940±15 nm diode laser
    Arm Type
    Experimental
    Arm Description
    In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser
    Arm Title
    SRP+Er,Cr:YSGG laser
    Arm Type
    Experimental
    Arm Description
    In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP+940±15 nm diode laser
    Intervention Description
    In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP+Er,Cr:YSGG laser
    Intervention Description
    In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing (SRP)-Control
    Intervention Description
    Only Non-surgical periodontal treatment
    Primary Outcome Measure Information:
    Title
    Periodontal Clinical Indices
    Description
    Bleeding on probing
    Time Frame
    1 year
    Title
    Periodontal Clinical Indices
    Description
    Plaque index
    Time Frame
    1 year
    Title
    Periodontal Clinical Indices
    Description
    Gingival index
    Time Frame
    1 year
    Title
    Periodontal Clinical Indices
    Description
    Probing pocket depth
    Time Frame
    1 year
    Title
    Periodontal Clinical Indices
    Description
    Clinical attachment level
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Cytokines levels in gingival crevicular fluids
    Description
    Interleukin-1β
    Time Frame
    1 year
    Title
    Cytokines levels in gingival crevicular fluids
    Description
    Interleukin-8
    Time Frame
    1 year
    Title
    Cytokines levels in gingival crevicular fluids
    Description
    Tumor necrosis factor-α
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: No systemic diseases Not used antibiotics or any other medication affecting the immune system in the previous six months Non-smokers Have at least 16 teeth in their mouth Have not received any periodontal treatment in the previous 6 months Exclusion Criteria: Under 18 age Pregnant women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmet C Talmac, PhD
    Organizational Affiliation
    Researcher
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20476883
    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.
    Results Reference
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    Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels

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