Diode Laser and SRP in Chronic Periodontitis

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.

Detailed Description
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The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser. Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.

Official Title
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Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: PAPD+SRP
* Procedure: Sham-laser +SRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP) A minimum of five natural teeth in each studied quadrant. Exclusion Criteria: History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases) Pregnancy or lactation Chronic high-dose steroid use Previous or current radiation or immunosuppressive therapies Ongoing orthodontic treatments Extensive carious lesions Recurrent antibiotic medications during the 6 months preceding the study Class III tooth mobility Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa

Ages Eligible for Study
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Minimum Age: 20 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PAPD+SRP Quadrant<br>This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP | Procedure: PAPD+SRP<br>* Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).<br>|
| Sham Comparator: Sham-laser + SRP<br>This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP | Procedure: Sham-laser +SRP<br>* Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD | Change in probing pocket depth | baseline, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAL | Change in mean attachment level | baseline, 1 year | 
| BoP | Change in mean bleeding on probing | baseline, 1 year | 
| PMN, DEC, bacteria | Change in mean additional disease markers, namely polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples. | baseline, 1 year | 
| Patient-reported outcomes | Individual evaluation of pain/discomfort assessed by a visual analogue score interview | baseline, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMN, Laser, periodontitis, scaling root planing, bacteria