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
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
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
NCT ID
NCT03034824
First Posted
December 21, 2016
Last Updated
February 22, 2017
Sponsor
Yuzuncu Yıl University
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
result
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Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels
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