Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients

NCT ID: NCT04694222

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-06-15

Brief Summary

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).

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

scaling and root planning (SRP) was applied.

Group Type: OTHER

Nd:YAG laser

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Nd:YAG laser

Intervention Type: DEVICE

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.

LLLT Group

after SRP Low Level Laser Therapy was performed using Nd:YAG laser.

Group Type: ACTIVE_COMPARATOR

Nd:YAG laser

Intervention Type: DEVICE

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.

LANAP+LLLT Group

after scaling both LANAP and LLLT were applied.

Group Type: ACTIVE_COMPARATOR

Nd:YAG laser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Turkısh Medicines And Medical Devices Agency

UNKNOWN

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Fadime KAYA DADAS

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serhat Köseoğlu

Role: STUDY_DIRECTOR

study manager

Locations

Katip Celebi University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kaya Dadas F, Genc Kocaayan S, Saglam M, Dadas OF, Koseoglu S. Evaluating efficacy of laser-assisted new attachment procedure and adjunctive low-level laser therapy in treating periodontitis: A single-blind randomized controlled clinical study. Lasers Med Sci. 2025 Apr 22;40(1):208. doi: 10.1007/s10103-025-04457-0.

Reference Type: DERIVED

PMID: 40259146 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-TDU-DİŞF-0040

Identifier Type: -

Identifier Source: org_study_id