Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Device: sham procedure; Device: photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01034501

CEP2112008

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

photodynamic therapy

Active Comparator group

Description:

photodynamic therapy 660 nm,40 mW,60 Hz

Treatment:

Device: photodynamic therapy

sham procedure

Sham Comparator group

Description:

Not activation of laser device

Treatment:

Device: sham procedure