The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change of C Reactive Protein (CRP) at 24 hour
研究概览
简要总结
The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.
详细描述
Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.
Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good health
- •No previous periodontal treatment
- •Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
- •Ability to understand the study procedures and comply with them through the length of the study
排除标准
- •Pregnancy and breast feeding
- •Need for antibiotic treatment during periodontal therapy
- •Chronic infections
- •Systemic diseases
- •Patients who report current smoking over 20 cigarettes per day
研究组 & 干预措施
Root Instrumentation + EMD Application
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
干预措施: Root Instrumentation (Procedure)
Root Instrumentation + EMD Application
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
干预措施: EMD Application (Device)
Root Instrumentation
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
干预措施: Root Instrumentation (Procedure)
结局指标
主要结局
Change of C Reactive Protein (CRP) at 24 hour
时间窗: Collected at Baseline and 24 hours in order to calculate the changes
CRP analyzed though blood sampling. Unit of measure: mg/L
次要结局
- Fibrinogen(Collected at Baseline, 24 hours and 3 months after treatment)
- LDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- HDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- D-Dimer(Collected at Baseline, 24 hours and 3 months after treatment)
- Clinical attachment level (CAL)(Measured at Baseline and 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
- Cystatin C(Collected at Baseline, 24 hours and 3 months after treatment)
- Number of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
- Triglyceride(Collected at Baseline, 24 hours and 3 months after treatment)
- Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- Full-mouth plaque score (FMPS)(Measured at Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 3 months after treatment)
- Glucose(Baseline, 24 hours and 3 months after treatment)
- Full-mouth bleeding score (FMBS)(Measured at Baseline and 3 months after treatment)
- Number of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- Pocket probing depth (PPD)(Measured at Baseline and 3 months after treatment)
- Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- C Reactive Protein (CRP) at 3 months(Collected 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Professor
University of Pisa