Chronic PeriodontitisNCT02851823
Combined Use of Er:YAG and Nd:YAG Laser
A study testing Periodontal curettes and Er-YAG+Nd-YAG lasers in people with Chronic Periodontitis, run by Izmir Katip Celebi University.
Trial summary
The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Periodontal curettes and Er-YAG+Nd-YAG lasers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients had ≥4 teeth per quadrant with probing depth (PD) of ≥5 mm, clinical attachment level (CAL) of ≥4 mm, and radiographic signs of alveolar bone loss. These individuals also had bleeding on probing (BOP) at >80% of the proximal sites.
Who cannot join
- Periodontal treatment received for the last 1 year; systemic diseases that could influence the outcome of the therapy, pregnancy, smoking, immunosuppressive chemotherapy; and use of antibiotics and anti-inflammatory drugs for the last 6 months.
About this study
Official title: Combined Application of ER:YAG and ND:YAG Lasers in Treatment of Chronic Periodontitis: A Split-mouth Randomized Controlled Trial
The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis.
Read the detailed description
The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis.Twenty-five systemically healthy patients with moderate-to-advanced periodontal destruction were selected for this study. The quadrants were randomly allocated in a split-mouth design to either combined Er:YAG (160 mj/pulse, and 10 Hz) and Nd:YAG laser (100 mJ/pulse, and 20 Hz) therapy (test group) or scaling root planning using hand instruments (control group). At baseline, 1 month, and 3 months after treatment, clinical measurements, including plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (%) (BOP), were performed and gingival crevicular fluid and subgingival plaque samples were taken. The gingival crevicular fluid levels of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) were analyzed by enzyme-linked immunosorbent assay. Total antioxidant status (TAS)/total oxidant status (TOS) were analyzed by high-performance liquid chromatography and a novel automatic colorimetric method. Quantitative analysis of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), and Treponema denticola (Td) was performed using real-time polymerase chain reaction (PCR) procedures.
- Conditions
- Chronic Periodontitis
- Being tested
- Periodontal curettes, Er-YAG+Nd-YAG lasers
- Keywords
- Er-YAG lasers, Nd-YAG lasers, chronic periodontitis, nonsurgical periodontal debridement
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal curettesDevice
Also called Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Er-YAG+Nd-YAG lasersDevice
Also called AT Fidelis Fotona, Ljubljana, Slovenia
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth. Receives: Device: Periodontal curettes |
| Test Group | Experimental | Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxification purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission. Receives: Device: Er-YAG+Nd-YAG lasers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 1 month Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 3 month
Measured: Baseline, 1 and 3 months
Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 1 month.
Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 3 month.
Measured: Baseline, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Dr. Mehmet Sağlam, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851823
- Sponsor's protocol ID
- 114S767
- Status last verified
- Oct 2017
- First submitted
- 25 Jul 2016
- Last updated
- 7 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of ER:YAG and ND:YAG Lasers in Treatment of Chronic Periodontitis: A Split-mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02851823
- Acronym / sponsor ID
- 114S767
- Conditions
- Chronic Periodontitis
- Keywords
- Er-YAG lasers, Nd-YAG lasers, chronic periodontitis, nonsurgical periodontal debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 7 Nov 2017
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 the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis.
Detailed description
The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis.Twenty-five systemically healthy patients with moderate-to-advanced periodontal destruction were selected for this study. The quadrants were randomly allocated in a split-mouth design to either combined Er:YAG (160 mj/pulse, and 10 Hz) and Nd:YAG laser (100 mJ/pulse, and 20 Hz) therapy (test group) or scaling root planning using hand instruments (control group). At baseline, 1 month, and 3 months after treatment, clinical measurements, including plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (%) (BOP), were performed and gingival crevicular fluid and subgingival plaque samples were taken. The gingival crevicular fluid levels of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) were analyzed by enzyme-linked immunosorbent assay. Total antioxidant status (TAS)/total oxidant status (TOS) were analyzed by high-performance liquid chromatography and a novel automatic colorimetric method. Quantitative analysis of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), and Treponema denticola (Td) was performed using real-time polymerase chain reaction (PCR) procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Periodontal curettesMechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth. |
| Test Group | Experimental | Device: Er-YAG+Nd-YAG lasersCombined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxification purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients had ≥4 teeth per quadrant with probing depth (PD) of ≥5 mm, clinical attachment level (CAL) of ≥4 mm, and radiographic signs of alveolar bone loss. These individuals also had bleeding on probing (BOP) at >80% of the proximal sites.
Key exclusion criteria (1 listed)
- Periodontal treatment received for the last 1 year; systemic diseases that could influence the outcome of the therapy, pregnancy, smoking, immunosuppressive chemotherapy; and use of antibiotics and anti-inflammatory drugs for the last 6 months.
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 |
|---|---|---|
| Periodontal curettesAlso: Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA | Device | Control Group |
| Er-YAG+Nd-YAG lasersAlso: AT Fidelis Fotona, Ljubljana, Slovenia | Device | Test Group |
Primary outcome
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
Time frame: Baseline, 1 and 3 months
Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 1 month Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 3 month
Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
Time frame: Baseline, 1 and 3 months
Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 1 month. Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 3 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal curettes and Er-YAG+Nd-YAG lasers in people with Chronic Periodontitis, run by Izmir Katip Celebi 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 1 inclusion and 1 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 7 Nov 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?
Yes. Results are posted in the registry (first posted 7 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm) (time frame: Baseline, 1 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2017.