Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- PASI (Psoriasis Area and Severity Index)- 10 weeks
研究概览
简要总结
Both periodontitis and plaque psoriasis are non communicable chronic inflammatory diseases. They share genetic polymorphysms (IL-1, IL-6 e TNFalfa) and risk factors (smoking, diabetes, obesity), as well as a great resemblance in terms of pathophysiological pathways. In fact, they are both characterized by an hyperactivation of the innate immune response which induces an excessive production of cytokines such as IL-17/TNFalfa. While non-surgical periodontal therapy consists in the mechanical removal of supra and subgingival calculus, psoriasis treatment involves the administration of either systemic or biologic drugs. Evidence is scarce regarding the effectiveness of non-surgical periodontal therapy in ameliorating the clinical outcomes of plaque psoriasis. The biological plausibility relies on the important reduction of systemic inflammation caused by periodontal treatment, which could ameliorate psoriasis phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of plaque psoriasis;
- •diagnosis of untreated periodontitis;
- •presence of at least 20 teeth;
- •age between 18 and 70 years;
- •ability and willingness to give informed consent.
排除标准
- •inability of unwillingness to give informed consent;
- •patients undergoing periodontal treatment within the last 6 months;
- •patients undergoing immunosuppressive treatments for other systemic diseases;
- •pregnancy or lactation;
- •pts undergoing antibiotic therapy.
结局指标
主要结局
PASI (Psoriasis Area and Severity Index)- 10 weeks
时间窗: PASI was registered 10 weeks after baseline.
A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4. Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.
PASI (Psoriasis Area and Severity Index)- Baseline
时间窗: PASI was registered at baseline.
A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4. Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.
次要结局
- Body Surface Area (BSA)- 10 weeks(BSA was registered 10 weeks after baseline.)
- Body Surface Area (BSA)- Baseline(BSA was registered at baseline.)
研究者
Simone Grandini
Full Professor
University of Siena