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

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ClinicalTrials.gov Identifier: NCT03034824
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmet Cemil Talmac, Yuzuncu Yıl University

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).

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Procedure: SRP+940±15 nm diode laser Procedure: SRP+Er,Cr:YSGG laser Procedure: Scaling and root planing (SRP)-Control Not Applicable

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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.

  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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Of Er,Cr:YSGG and Diode Laser on the Periodontal Parameters and Cytokines Levels in Patients With Generalized Aggressive Periodontitis
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Scaling and root planing (SRP)-Control
Only non-surgical initial periodontal treatment (scaling and root planing)
Procedure: Scaling and root planing (SRP)-Control
Only Non-surgical periodontal treatment

Experimental: SRP+940±15 nm diode laser
In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser
Procedure: SRP+940±15 nm diode laser
In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.

Experimental: SRP+Er,Cr:YSGG laser
In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser
Procedure: SRP+Er,Cr:YSGG laser
In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.




Primary Outcome Measures :
  1. Periodontal Clinical Indices [ Time Frame: 1 year ]
    Bleeding on probing

  2. Periodontal Clinical Indices [ Time Frame: 1 year ]
    Plaque index

  3. Periodontal Clinical Indices [ Time Frame: 1 year ]
    Gingival index

  4. Periodontal Clinical Indices [ Time Frame: 1 year ]
    Probing pocket depth

  5. Periodontal Clinical Indices [ Time Frame: 1 year ]
    Clinical attachment level


Secondary Outcome Measures :
  1. Cytokines levels in gingival crevicular fluids [ Time Frame: 1 year ]
    Interleukin-1β

  2. Cytokines levels in gingival crevicular fluids [ Time Frame: 1 year ]
    Interleukin-8

  3. Cytokines levels in gingival crevicular fluids [ Time Frame: 1 year ]
    Tumor necrosis factor-α



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034824


Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Principal Investigator: Ahmet C Talmac, PhD Researcher

Publications of Results:
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Responsible Party: Ahmet Cemil Talmac, PhD, Dr. Dt., Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03034824     History of Changes
Other Study ID Numbers: JOP-16-0797
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ahmet Cemil Talmac, Yuzuncu Yıl University:
diode laser
Er,Cr:YSGG laser
Aggressive Periodontitis
Clinical periodontal parameters
Gingival crevicular fluid cytokines levels
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms