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Combined Use of Er:YAG and Nd:YAG Laser

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ClinicalTrials.gov Identifier: NCT02851823
Recruitment Status : Completed
First Posted : August 2, 2016
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Tubitak
Information provided by (Responsible Party):
Dr. Mehmet Sağlam, Izmir Katip Celebi University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Periodontitis
Interventions Device: Periodontal curettes
Device: Er-YAG+Nd-YAG lasers
Enrollment 25
Recruitment Details  
Pre-assignment Details Split-mouth design (test and control in the same patient).
Arm/Group Title Combined Er:YAG and Nd:YAG Laser vs Scaling and Root Planing
Hide Arm/Group Description Combined Er:YAG and Nd:YAG Laser Application Left Side, Scaling and Root Planning Procedure Right Side" and "Scaling and Root Planning Procedure Left Side, Combined Er:YAG and Nd:YAG Laser Application Right Side
Period Title: Overall Study
Started 25
1 Month [1] 25
3 Months [2] 25
Completed 25
Not Completed 0
[1]
1 month after therapy
[2]
3 months after therapy
Arm/Group Title Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing
Hide Arm/Group Description One side (left or right) of the mouth received Er:YAG+Nd:YAG laser therapy (test group) and other side received scaling and root planing with hand instruments (control group)
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  96.0%
>=65 years
1
   4.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
15
  60.0%
Male
10
  40.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Turkey Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Test Group
Hide Arm/Group 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.

Periodontal curettes

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.

Er-YAG+Nd-YAG lasers

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: mm
Change in CAL at 1 month 2.07  (0.99) 2.12  (0.97)
Change in CAL at 3 months 2.06  (1.04) 2.09  (1.07)
2.Primary Outcome
Title Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Test Group
Hide Arm/Group 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.

Periodontal curettes

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.

Er-YAG+Nd-YAG lasers

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: mm
Change in CAL at 1 month 3.74  (1.35) 4.23  (0.99)
Change in CAL at 3 months 3.98  (1.45) 4.66  (0.93)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Test Group
Hide Arm/Group 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.

Periodontal curettes

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.

Er-YAG+Nd-YAG lasers

All-Cause Mortality
Control Group Test Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Test Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Test Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Assoc.Prof.Dr. Mehmet Sağlam
Organization: Izmir Katip Celebi University, Dentistry Faculty
Phone: +90 530 324 99 48
Responsible Party: Dr. Mehmet Sağlam, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT02851823     History of Changes
Other Study ID Numbers: 114S767
First Submitted: July 25, 2016
First Posted: August 2, 2016
Results First Submitted: March 2, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017