Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients (LANAP LLLT)
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nd:YAG laser
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Laser Assisted New Attachment Procedure, Low Level Laser Therapy, periodontitis, non-surgical periodontal therapy
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
Sites / Locations
- Katip Celebi University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group
LANAP Group
LLLT Group
LANAP+LLLT Group
Arm Description
scaling and root planning (SRP) was applied.
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.
after SRP Low Level Laser Therapy was performed using Nd:YAG laser.
after scaling both LANAP and LLLT were applied.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Probing depth
It is determined by measuring the distance from the gingival margin to the pocket base
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Gingival index
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Plaque index
This index measures the thickness of plaque on gingival one third
Plaque index
This index measures the thickness of plaque on gingival one third
Plaque index
This index measures the thickness of plaque on gingival one third
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.
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.
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.
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Interleukin-1beta
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Interleukin-10
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
vascular endothelial growth factor (VEGF)
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Radiographic bone fill
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Full Information
NCT ID
NCT04694222
First Posted
December 30, 2020
Last Updated
January 1, 2021
Sponsor
Izmir Katip Celebi University
Collaborators
Turkısh Medicines And Medical Devices Agency
1. Study Identification
Unique Protocol Identification Number
NCT04694222
Brief Title
Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients
Acronym
LANAP LLLT
Official Title
Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Turkısh Medicines And Medical Devices Agency
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Laser Assisted New Attachment Procedure, Low Level Laser Therapy, periodontitis, non-surgical periodontal therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blind randomized controlled clinical study
Masking
Outcomes Assessor
Masking Description
Clinical measurements were performed by a masked calibrated researcher to provide blindness
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
scaling and root planning (SRP) was applied.
Arm Title
LANAP Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LLLT Group
Arm Type
Active Comparator
Arm Description
after SRP Low Level Laser Therapy was performed using Nd:YAG laser.
Arm Title
LANAP+LLLT Group
Arm Type
Active Comparator
Arm Description
after scaling both LANAP and LLLT were applied.
Intervention Type
Device
Intervention Name(s)
Nd:YAG laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level gain
Description
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.
Time Frame
Baseline
Title
Clinical attachment level gain
Description
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.
Time Frame
1 month
Title
Clinical attachment level gain
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Probing depth
Description
It is determined by measuring the distance from the gingival margin to the pocket base
Time Frame
Baseline
Title
Probing depth
Description
It is determined by measuring the distance from the gingival margin to the pocket base
Time Frame
1 Month
Title
Probing depth
Description
It is determined by measuring the distance from the gingival margin to the pocket base
Time Frame
3 Month
Title
Gingival index
Description
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Time Frame
Baseline
Title
Gingival index
Description
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Time Frame
1 Month
Title
Gingival index
Description
For assessing severity of gingivitis, and its location by examining qualitative changes of gingival tissues
Time Frame
3 Month
Title
Plaque index
Description
This index measures the thickness of plaque on gingival one third
Time Frame
Baseline
Title
Plaque index
Description
This index measures the thickness of plaque on gingival one third
Time Frame
1 Month
Title
Plaque index
Description
This index measures the thickness of plaque on gingival one third
Time Frame
3 Month
Title
Bleeding on probing
Description
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.
Time Frame
Baseline
Title
Bleeding on probing
Description
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.
Time Frame
1 Month
Title
Bleeding on probing
Description
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.
Time Frame
3 Month
Title
Interleukin-1beta
Description
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Time Frame
Baseline
Title
Interleukin-1beta
Description
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Time Frame
1 Month
Title
Interleukin-1beta
Description
IL-1 is a protein produced mainly by monocytes and macrophages as a polyclonal activator.
Time Frame
3 Month
Title
Interleukin-10
Description
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Time Frame
Baseline
Title
Interleukin-10
Description
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Time Frame
1 Month
Title
Interleukin-10
Description
IL-10 is an 18 kilodalton (KD) cytokine with a wide variety of (pleiotropic) effects.
Time Frame
3 Month
Title
vascular endothelial growth factor (VEGF)
Description
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Time Frame
Baseline
Title
vascular endothelial growth factor (VEGF)
Description
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Time Frame
1 Month
Title
vascular endothelial growth factor (VEGF)
Description
VEGF is a glycoprotein molecule that is a potential stimulator of angiogenesis.
Time Frame
3 Month
Title
Radiographic bone fill
Description
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Time Frame
Baseline
Title
Radiographic bone fill
Description
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Time Frame
1 Month
Title
Radiographic bone fill
Description
The effects of treatments on bone loss were evaluated by making some measurements on periapical radiography.
Time Frame
3 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serhat Köseoğlu
Organizational Affiliation
study manager
Official's Role
Study Director
Facility Information:
Facility Name
Katip Celebi University
City
Izmir
ZIP/Postal Code
35000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients
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