Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham

Detailed Description
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The goal of periodontal treatment is to restore tissue health through the elimination and control of etiologic factors, reducing the microbial aggression. Some microorganisms persist in the root surface even after scraping. Thus, the conventional mechanical treatment may fail to reduce the number of periodontal pathogens to levels compatible with health. This study will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis.

Official Title
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Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Device: sham procedure
* Device: photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Periodontitis (Tonetti, Claffey, 2005) 10 or more teeth 2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation Exclusion Criteria: Profilatic antibiotics Diabetes, immunosuppression, pregnancy nursing mother Smoking Medication that might interfere with periodontal healing Previous periodontal treatment or antibiotics (6 months) Experimental teeth with mobility II or III, or endodontic problem

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: photodynamic therapy<br>photodynamic therapy 660 nm,40 mW,60 Hz | Device: photodynamic therapy<br>* photodynamic therapy 660 nm,40 mW,60 Hz<br>* Other names: Laser Hand - MM Optics (ANVISA: 80051420009);|
| Sham Comparator: sham procedure<br>Not activation of laser device | Device: sham procedure<br>* non activated laser tip<br>* Other names: Laser Hand - MM Optics (ANVISA: 80051420009);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean attachment level |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in probing pocket depth |  | 12 months | 
| Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts. |  | 12 months | 
| Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, photodynamic therapy