- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02851823
Combined Use of Er:YAG and Nd:YAG Laser
October 8, 2017 updated by: Dr. Mehmet Sağlam, Izmir Katip Celebi University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
Time Frame: Baseline, 1 and 3 months
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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
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Baseline, 1 and 3 months
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Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
Time Frame: Baseline, 1 and 3 months
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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. |
Baseline, 1 and 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
July 25, 2016
First Submitted That Met QC Criteria
July 28, 2016
First Posted (Estimate)
August 2, 2016
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
October 8, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114S767
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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