CClinicalTrials.gg
CompletedNCT02851823Updated Nov 7, 2017Results posted

Combined Use of Er:YAG and Nd:YAG Laser

An interventional study of Periodontal curettes and Er-YAG+Nd-YAG lasers in Chronic Periodontitis, sponsored by Izmir Katip Celebi University. Completed. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • Er-YAG lasers
  • Nd-YAG lasers
  • chronic periodontitis
  • nonsurgical periodontal debridement
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 25 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Control Group

    Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.

    Device: Periodontal curettes

  • Experimental
    Test Group

    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.

    Device: Er-YAG+Nd-YAG lasers

Interventions

  • DevicePeriodontal curettes

    Also known as: Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

  • DeviceEr-YAG+Nd-YAG lasers

    Also known as: AT Fidelis Fotona, Ljubljana, Slovenia

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 1 and 3 months

  2. 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.

    Time frame: Baseline, 1 and 3 months

07

Results

Posted Nov 7, 2017

Participant flow

Participant flow — Overall Study
MilestoneCombined Er:YAG and Nd:YAG Laser vs Scaling and Root Planing
Started25
1 month25
3 months25
Completed25
Not completed0

Outcome measures

PrimaryClinical 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

Time frame:
Baseline, 1 and 3 months
Reported as:
Mean · mm
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
mmControl GroupTest Group
Change in CAL at 1 month2.07 ± 0.992.12 ± 0.97
Change in CAL at 3 months2.06 ± 1.042.09 ± 1.07
PrimaryClinical 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.

Time frame:
Baseline, 1 and 3 months
Reported as:
Mean · mm
Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
mmControl GroupTest Group
Change in CAL at 1 month3.74 ± 1.354.23 ± 0.99
Change in CAL at 3 months3.98 ± 1.454.66 ± 0.93

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group—0/25 (0%)0/25 (0%)
Test Group—0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing
<=18 years0
Between 18 and 65 years24
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing
Female15
Male10
Region of Enrollment
Region of Enrollment(Participants)Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing
Turkey25
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02851823
Lead sponsor
Izmir Katip Celebi University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Dr. Mehmet Sağlam (Principal investigator, Department of Periodontology, Faculty of Dentistry, Izmir Katip Celebi University, Izmir Katip Celebi University) — Principal investigator
First posted
Aug 2, 2016
Start date
Oct 2014
Primary completion
Oct 2015
Completion
Apr 2016
Results posted
Nov 7, 2017
Last update
Nov 7, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion