search
Back to results

Combined Use of Er:YAG and Nd:YAG Laser

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal curettes
Er-YAG+Nd-YAG lasers
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Er-YAG lasers, Nd-YAG lasers, chronic periodontitis, nonsurgical periodontal debridement

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control Group

    Test Group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2016
    Last Updated
    October 8, 2017
    Sponsor
    Izmir Katip Celebi University
    Collaborators
    The Scientific and Technological Research Council of Turkey
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02851823
    Brief Title
    Combined Use of Er:YAG and Nd:YAG Laser
    Official Title
    Combined Application of ER:YAG and ND:YAG Lasers in Treatment of Chronic Periodontitis: A Split-mouth Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University
    Collaborators
    The Scientific and Technological Research Council of Turkey

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Er-YAG lasers, Nd-YAG lasers, chronic periodontitis, nonsurgical periodontal debridement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    split-mouth
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.
    Arm Title
    Test Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Periodontal curettes
    Other Intervention Name(s)
    Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
    Intervention Type
    Device
    Intervention Name(s)
    Er-YAG+Nd-YAG lasers
    Other Intervention Name(s)
    AT Fidelis Fotona, Ljubljana, Slovenia
    Primary Outcome Measure Information:
    Title
    Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
    Description
    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
    Title
    Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Use of Er:YAG and Nd:YAG Laser

    We'll reach out to this number within 24 hrs