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Aggressive PeriodontitisNCT03034824

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

A study testing SRP+940±15 nm diode laser and SRP+Er,Cr:YSGG laser in people with Aggressive Periodontitis, run by Yuzuncu Yil University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 30 years
Conditions the study is for
Aggressive Periodontitis
What is being tested?
SRP+940±15 nm diode laser and SRP+Er,Cr:YSGG laser
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Jan 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Under 18 age
  • Pregnant women

About this study

Official title: Comparison Of Er,Cr:YSGG and Diode Laser on the Periodontal Parameters and Cytokines Levels in Patients With Generalized Aggressive Periodontitis

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).

Read the 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.

Being tested
SRP+940±15 nm diode laser, SRP+Er,Cr:YSGG laser, Scaling and root planing (SRP)-Control
Keywords
diode laser, Er,Cr:YSGG laser, Aggressive Periodontitis, Clinical periodontal parameters, Gingival crevicular fluid cytokines levels
Medical subject headings
Aggressive Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRP+940±15 nm diode laserProcedure or surgery

    In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.

  • SRP+Er,Cr:YSGG laserProcedure or surgery

    In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.

  • Scaling and root planing (SRP)-ControlProcedure or surgery

    Only Non-surgical periodontal treatment

Study groups in NCT03034824
Study groupRoleWhat they receive
Scaling and root planing (SRP)-ControlExperimentalOnly non-surgical initial periodontal treatment (scaling and root planing)
Receives: Procedure: Scaling and root planing (SRP)-Control
SRP+940±15 nm diode laserExperimentalIn addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser
Receives: Procedure: SRP+940±15 nm diode laser
SRP+Er,Cr:YSGG laserExperimentalIn addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser
Receives: Procedure: SRP+Er,Cr:YSGG laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periodontal Clinical Indices

    Bleeding on probing

    Measured: 1 year

  2. Periodontal Clinical Indices

    Plaque index

    Measured: 1 year

  3. Periodontal Clinical Indices

    Gingival index

    Measured: 1 year

  4. Periodontal Clinical Indices

    Probing pocket depth

    Measured: 1 year

  5. Periodontal Clinical Indices

    Clinical attachment level

    Measured: 1 year

Secondary outcomes (3)
  1. Cytokines levels in gingival crevicular fluids

    Interleukin-1β

    Measured: 1 year

  2. Cytokines levels in gingival crevicular fluids

    Interleukin-8

    Measured: 1 year

  3. Cytokines levels in gingival crevicular fluids

    Tumor necrosis factor-α

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2014
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034824
Sponsor's protocol ID
JOP-16-0797
Status last verified
Feb 2017
First submitted
21 Dec 2016
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20476883

Questions about this trial

What is this clinical trial studying?

A study testing SRP+940±15 nm diode laser and SRP+Er,Cr:YSGG laser in people with Aggressive Periodontitis, run by Yuzuncu Yil University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal Clinical Indices (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.

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