Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Diabetes-affected Subjects: A Randomized Clinical Trial
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
- Levels C-Reactive Protein
研究概览
简要总结
Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach (Q-SRP).
Patients will be seen one day and three months (study completion) after treatment. The 24 hours appointment will be occurring after the entire completion of the FM-SRP or the first quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed within the following 3 weeks.
At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial parameters will be collected. Periodontal parameters will be checked at baseline and at three months.
Main outcome of the study is the level of C-reactive protein 24 hours after treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by Periodontal disease
- •20% of periodontal pockets of the entire dentition
- •20% bleeding on probing of the entire dentition
- •documented radiographic bone loss
- •Diagnosis of Diabetes Type 2 as measured through international standards
排除标准
- •age younger than 18 years and older than 80 years
- •pregnant or lactating females
- •females using contraceptive methods
- •need of antibiotic coverage for periodontal treatment
- •previous periodontal treatment in the last 6 months.
结局指标
主要结局
Levels C-Reactive Protein
时间窗: Baseline, 24 hours and 3 months after treatment
Changes in C reactive protein (CRP). Unit of measure: mg/L
次要结局
- Full Mouth Plaque Score (FMPS)(Baseline and 3 months after treatment)
- Clinical attachment level (CAL)(Baseline and 3 months after treatment)
- Low-density lipoprotein (LDL)(Baseline, 24 hours and 3 months after treatment)
- Full Mouth Bleeding Score (FMBS)(Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Baseline and 3 months after treatment)
- Pocket probing depth (PPD)(Baseline and 3 months after treatment)
- Triglycerides(Baseline, 24 hours and 3 months after treatment)
- Cholesterol(Baseline, 24 hours and 3 months after treatment)
- High-density lipoprotein (HDL)(Baseline, 24 hours and 3 months after treatment)
- Glycated Haemoglobin(Baseline, 24 hours and 3 months after treatment)
- Systolic Blood Pressure (SBP)(Baseline, 24 hours and 3 months after treatment)
- Endothelial Function(Baseline, 24 hours and 3 months after treatment)
- Glycemia(Baseline, 24 hours and 3 months after treatment)
- Diastolic Blood Pressure (DBP)(Baseline, 24 hours and 3 months after treatment)
- Insulin(Baseline, 24 hours and 3 months after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Professor of Periodontology
University of Pisa