Acute-phase Response Following Full-mouth Versus Quadrant Non-surgical Periodontal Treatment in Obese 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
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical periodontal treatment in obese patients affected by periodontitis.
详细描述
Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on obese patients with periodontitis.
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment.
Treatment will be provided using both hand and ultrasonic instrumentation with fine tips.
FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.
Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.
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 Obesity as measured through Body Mass Index (BMI) superior than 30
排除标准
- •age younger than 18 years and older than 80 years
- •pregnant or lactating females
- •need of antibiotic coverage for periodontal treatment
- •treatment with statin and/or acetylsalicylic acid
- •BMI > 35
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 Bleeding Score (FMBS)(Baseline and 3 months after treatment)
- Full Mouth Plaque Score (FMPS)(Baseline and 3 months after treatment)
- Pocket probing depth (PPD)(Baseline and 3 months after treatment)
- Clinical attachment level (CAL)(Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Baseline and 3 months after treatment)
- Low-density lipoprotein (LDL)(Baseline, 24 hours and 3 months after treatment)
- Glycaemia(Baseline, 24 hours and 3 months after treatment)
- Endothelial Function(Baseline, 24 hours and 3 months after treatment)
- Triglycerides(Baseline, 24 hours and 3 months after treatment)
- High-density lipoprotein (HDL)(Baseline, 24 hours and 3 months after treatment)
- Cholesterol(Baseline, 24 hours and 3 months after treatment)
- Glycated Hemoglobin(Baseline and 3 months after treatment)
- Insulin(Baseline, 24 hours and 3 months after treatment)
- Systolic Blood Pressure (SBP)(Baseline, 24 hours and 3 months after treatment)
- Diastolic Blood Pressure (DBP)(Baseline, 24 hours and 3 months after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Professor of Periodontology
University of Pisa