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.
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.
- 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.
- Conditions
- Aggressive Periodontitis
- 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 group | Role | What they receive |
|---|---|---|
| Scaling and root planing (SRP)-Control | Experimental | Only non-surgical initial periodontal treatment (scaling and root planing) Receives: Procedure: Scaling and root planing (SRP)-Control |
| SRP+940±15 nm diode laser | Experimental | In 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 laser | Experimental | In 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.
Periodontal Clinical Indices
Bleeding on probing
Measured: 1 year
Periodontal Clinical Indices
Plaque index
Measured: 1 year
Periodontal Clinical Indices
Gingival index
Measured: 1 year
Periodontal Clinical Indices
Probing pocket depth
Measured: 1 year
Periodontal Clinical Indices
Clinical attachment level
Measured: 1 year
Secondary outcomes (3)
Cytokines levels in gingival crevicular fluids
Interleukin-1β
Measured: 1 year
Cytokines levels in gingival crevicular fluids
Interleukin-8
Measured: 1 year
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.
- First posted27 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Cemil Talmac, Yuzuncu Yil University
- Investigators
- Ahmet C Talmac, PhD, Principal investigator, Researcher
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Er,Cr:YSGG and Diode Laser on the Periodontal Parameters and Cytokines Levels in Patients With Generalized Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT03034824
- Acronym / sponsor ID
- JOP-16-0797
- Conditions
- Aggressive Periodontitis
- Keywords
- diode laser, Er,Cr:YSGG laser, Aggressive Periodontitis, Clinical periodontal parameters, Gingival crevicular fluid cytokines levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing (SRP)-Control | Experimental | Procedure: Scaling and root planing (SRP)-ControlOnly non-surgical initial periodontal treatment (scaling and root planing) |
| SRP+940±15 nm diode laser | Experimental | Procedure: SRP+940±15 nm diode laserIn addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser |
| SRP+Er,Cr:YSGG laser | Experimental | Procedure: SRP+Er,Cr:YSGG laserIn addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Under 18 age
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP+940±15 nm diode laserIn addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser. | Procedure or surgery | SRP+940±15 nm diode laser |
| SRP+Er,Cr:YSGG laserIn addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser. | Procedure or surgery | SRP+Er,Cr:YSGG laser |
| Scaling and root planing (SRP)-ControlOnly Non-surgical periodontal treatment | Procedure or surgery | Scaling and root planing (SRP)-Control |
Primary outcome
Periodontal Clinical Indices
Time frame: 1 year
Bleeding on probing
Periodontal Clinical Indices
Time frame: 1 year
Plaque index
Periodontal Clinical Indices
Time frame: 1 year
Gingival index
Periodontal Clinical Indices
Time frame: 1 year
Probing pocket depth
Periodontal Clinical Indices
Time frame: 1 year
Clinical attachment level
3 secondary outcomes
Cytokines levels in gingival crevicular fluids
Time frame: 1 year
Cytokines levels in gingival crevicular fluids
Time frame: 1 year
Cytokines levels in gingival crevicular fluids
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Results publication: PubMed 20476883Hakki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet C Talmac, PhD principal investigator
Researcher
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.