Chronic Periodontitis
Conditions
Keywords
periodontitis, photodynamic therapy
Brief summary
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
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.
Interventions
DEVICEsham procedure
non activated laser tip
DEVICEphotodynamic therapy
photodynamic therapy 660 nm,40 mW,60 Hz
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean attachment level | 12 months |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed