Clinical trial NCT04694222: Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients
Official title: Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Laser Assisted New Attachment Procedure
Low Level Laser Therapy
periodontitis
non-surgical periodontal therapy
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Turkısh Medicines And Medical Devices Agency
First posted: 2021-01-05
Enrollment: 89
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind randomized controlled clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical attachment level gain
timeFrame: Baseline
measure: Clinical attachment level gain
timeFrame: 1 month
measure: Clinical attachment level gain
timeFrame: 3 month
Secondary outcomes:
measure: Probing depth
timeFrame: Baseline
measure: Probing depth
timeFrame: 1 Month
measure: Probing depth
timeFrame: 3 Month
measure: Gingival index
timeFrame: Baseline
measure: Gingival index
timeFrame: 1 Month
measure: Gingival index
timeFrame: 3 Month
measure: Plaque index
timeFrame: Baseline
measure: Plaque index
timeFrame: 1 Month
measure: Plaque index
timeFrame: 3 Month
measure: Bleeding on probing
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: 1 Month
measure: Bleeding on probing
timeFrame: 3 Month
measure: Interleukin-1beta
timeFrame: Baseline
measure: Interleukin-1beta
timeFrame: 1 Month
measure: Interleukin-1beta
timeFrame: 3 Month
measure: Interleukin-10
timeFrame: Baseline
measure: Interleukin-10
timeFrame: 1 Month
measure: Interleukin-10
timeFrame: 3 Month
measure: vascular endothelial growth factor (VEGF)
timeFrame: Baseline
measure: vascular endothelial growth factor (VEGF)
timeFrame: 1 Month
measure: vascular endothelial growth factor (VEGF)
timeFrame: 3 Month
measure: Radiographic bone fill
timeFrame: Baseline
measure: Radiographic bone fill
timeFrame: 1 Month
measure: Radiographic bone fill
timeFrame: 3 Month
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Katip Celebi University
Study officials:
affiliation: study manager
name: Serhat Köseoğlu
role: STUDY_DIRECTOR
References: