Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical 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 surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.
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)
盲法说明
The examiner were not aware of group allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good health
- •No previous periodontal surgical treatment
- •Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)
- •Ability to understand the study procedures and comply with them through the length of the study
排除标准
- •Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)
- •The need for antibiotic therapy to undergo periodontal therapy
- •Chronic infections
- •Systemic diseases
- •Patients who report current smoking over 20 cigarettes per day or pipe or cigar
研究组 & 干预措施
Periodontal Surgery with EMD
A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability.
干预措施: Periodontal surgery (Procedure)
Periodontal Surgery with EMD
A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability.
干预措施: EMD application (Procedure)
Periodontal Surgery
A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.
干预措施: Periodontal surgery (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
- Glucose(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- Triglycerides(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- HDL Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- LDL Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- Fibrinogen(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- D-Dimer(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- Cystatin C(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- C Reactive Protein (CRP)(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- Pocket probing depth (PPD) at deepest site(Measured at Baseline and 6 months after treatment)
- Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
- Clinical attachment level (CAL) at deepest site(Measured at Baseline and 6 months after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 6 months after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Clinical Professor
University of Pisa