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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Device: Nd:YAG laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blind randomized controlled clinical study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>scaling and root planning (SRP) was applied. | Device: Nd:YAG laser<br>* 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.<br>|
| Active Comparator: LANAP Group<br>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<br>* 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.<br>|
| Active Comparator: LLLT Group<br>after SRP Low Level Laser Therapy was performed using Nd:YAG laser. | Device: Nd:YAG laser<br>* 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.<br>|
| Active Comparator: LANAP+LLLT Group<br>after scaling both LANAP and LLLT were applied. | Device: Nd:YAG laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Assisted New Attachment Procedure, Low Level Laser Therapy, periodontitis, non-surgical periodontal therapy