Trial Outcomes & Findings for Combined Use of Er:YAG and Nd:YAG Laser (NCT NCT02851823)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline, 1 and 3 months

Results posted on

2017-11-07

Participant Flow

Split-mouth design (test and control in the same patient).

Participant milestones

Participant milestones
Measure	Combined Er:YAG and Nd:YAG Laser vs Scaling and Root Planing 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
Overall Study STARTED	25
Overall Study 1 Month	25
Overall Study 3 Months	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Use of Er:YAG and Nd:YAG Laser

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Er:YAG+ Nd:YAG Laser Versus Scaling Root Planing n=25 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Turkey	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=25 Participants 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	Test Group n=25 Participants 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
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm) Change in CAL at 1 month	2.07 mm Standard Deviation 0.99	2.12 mm Standard Deviation 0.97
Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm) Change in CAL at 3 months	2.06 mm Standard Deviation 1.04	2.09 mm Standard Deviation 1.07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=25 Participants 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	Test Group n=25 Participants 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
Clinical Attachment Level Change for Deep Pockets (7 mm≤PD) Change in CAL at 1 month	3.74 mm Standard Deviation 1.35	4.23 mm Standard Deviation 0.99
Clinical Attachment Level Change for Deep Pockets (7 mm≤PD) Change in CAL at 3 months	3.98 mm Standard Deviation 1.45	4.66 mm Standard Deviation 0.93

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assoc.Prof.Dr. Mehmet Sağlam

Izmir Katip Celebi University, Dentistry Faculty

Phone: +90 530 324 99 48

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place