Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- C reactive Protein
研究概览
简要总结
This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.
详细描述
Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.
Material & Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.
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
- Double (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
- •Patients presenting with probing pocket depths (PPD) ≥5 mm,
- •bleeding on probing on at least 25% of their total sites
- •documented radiographic alveolar bone loss
排除标准
- •age earlier than 18 and older than 70 years;
- •pregnant or lactating females;
- •females using contraceptive methods;
- •reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
- •any pharmacological treatment within the 3 months before the beginning of the study;
- •PT in the previous 6 months.
结局指标
主要结局
C reactive Protein
时间窗: 24 Hours
次要结局
- Full Mouth Plaque Score(90 days)
- Full Mouth Bleeding Score(90 days)
- clinical attachment level (CAL)(90 days)
- Interleukin - 6(24 Hours, 7 days, 90 days)
- number of pockets > 4 mm(90 days)
- C reactive Protein(7 days, 90 days)
- Tumor Necrosis Factor - alpha(24 Hours, 7 days, 90 days)
- periodontal pocket depth (PPD)(90 days)
研究者
Filippo Graziani, DDS MClinDent PhD
Associate Professor
University of Pisa