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

Periodontitis Clinical Trial

— LANAP LLLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694222
• Other study ID #: 2017-TDU-DISF-0040
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: January 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 15, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Katip Celebi University	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Turkish Medicines And Medical Devices Agency

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	Baseline
Secondary	Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	1 Month
Secondary	Probing depth	It is determined by measuring the distance from the gingival margin to the pocket base	3 Month
Secondary	Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	Baseline
Secondary	Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	1 Month
Secondary	Gingival index	For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues	3 Month
Secondary	Plaque index	This index measures the thickness of plaque on gingival one third	Baseline
Secondary	Plaque index	This index measures the thickness of plaque on gingival one third	1 Month
Secondary	Plaque index	This index measures the thickness of plaque on gingival one third	3 Month
Secondary	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
Secondary	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
Secondary	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
Secondary	Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	Baseline
Secondary	Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	1 Month
Secondary	Interleukin-1beta	IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.	3 Month
Secondary	Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	Baseline
Secondary	Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	1 Month
Secondary	Interleukin-10	IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.	3 Month
Secondary	vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	Baseline
Secondary	vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	1 Month
Secondary	vascular endothelial growth factor (VEGF)	VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.	3 Month
Secondary	Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	Baseline
Secondary	Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	1 Month
Secondary	Radiographic bone fill	The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.	3 Month