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

NCT04694222 | Completed DMC FDA Device

• 1 other identifier: 2017-TDU-DİŞF-0040
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontitis

Keywords

Laser Assisted New Attachment Procedure; Low Level Laser Therapy; periodontitis; non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Probing depth

  Baseline

• Probing depth

  1 Month

• Probing depth

  3 Month

• Gingival index

  Baseline

• Gingival index

  1 Month

Study Arms (4)

Control Group

OTHER

scaling and root planning (SRP) was applied.

Device: Nd:YAG laser

LANAP Group

ACTIVE COMPARATOR

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

LLLT Group

ACTIVE COMPARATOR

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

Device: Nd:YAG laser

LANAP+LLLT Group

ACTIVE COMPARATOR

after scaling both LANAP and LLLT were applied.

Device: Nd:YAG laser

Interventions

Nd:YAG laser 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.

Control Group; LANAP Group; LANAP+LLLT Group; LLLT Group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Turkısh Medicines And Medical Devices Agency: collaborator

Study Sites (1)

Katip Celebi University

Izmir, 35000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40259146 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Serhat Köseoğlu

  study manager

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical measurements were performed by a masked calibrated researcher to provide blindness
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: single-blind randomized controlled clinical study

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: October 2, 2017
• Primary Completion: April 16, 2018
• Study Completion: June 15, 2018
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)