Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients (LANAP LLLT)

Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study

In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: Nd:YAG laser

Detailed Description

The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.

In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.

Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35000
    • Katip Celebi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• periodontitis of periodontal stage II, III, or IV with grades B
• with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
• with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
• radiographic evidence of alveolar bone loss

Exclusion Criteria:

• smoking
• pregnancy and lactation
• using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
• having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control Group; scaling and root planning (SRP) was applied.	Device: Nd:YAG laser; For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
ACTIVE_COMPARATOR: LANAP Group; After scaling and polishing, three LANAP stages were performed : In the first stage, Nd:YAG laser was applied. In the second stage, full mouth SRP procedure was performed. In the third stage, Nd:YAG laser was applied again.	Device: Nd:YAG laser; For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
ACTIVE_COMPARATOR: LLLT Group; after SRP Low Level Laser Therapy was performed using Nd:YAG laser.	Device: Nd:YAG laser; For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
ACTIVE_COMPARATOR: LANAP+LLLT Group; after scaling both LANAP and LLLT were applied.	Device: Nd:YAG laser; For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level gain	The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.	Baseline
Clinical attachment level gain	The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.	1 month
Clinical attachment level gain	The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	Baseline
Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	1 Month
Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	3 Month
Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	Baseline
Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	1 Month
Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	3 Month
Plaque index	This index measures the thickness of plaque on gingival one third	Baseline
Plaque index	This index measures the thickness of plaque on gingival one third	1 Month
Plaque index	This index measures the thickness of plaque on gingival one third	3 Month
Bleeding on probing	In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.	Baseline
Bleeding on probing	In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.	1 Month
Bleeding on probing	In this index, probing is performed by gently walking around the pocket and bleeding is evaluated. As a result of probing, evaluation is made by looking at the presence or absence of bleeding in the gingiva.	3 Month
Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	Baseline
Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	1 Month
Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	3 Month
Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	Baseline
Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	1 Month
Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	3 Month
vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	Baseline
vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	1 Month
vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	3 Month
Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	Baseline
Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	1 Month
Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	3 Month

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Collaborators: Turkısh Medicines And Medical Devices Agency
• Investigators: Study Director: Serhat Köseoğlu, Study Manager

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ACTUAL): April 16, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 1, 2021
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: periodontitis; non-surgical periodontal therapy; Low Level Laser Therapy; Laser Assisted New Attachment Procedure
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 2017-TDU-DİŞF-0040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes