Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in C-reactive protein
研究概览
简要总结
A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional plaque removal and placebo capsules). Blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Metabolic Syndrome according to the IDF definition
- •at least 16 teeth
- •at least eight sites with probing pocket depth (PPD) ≥ 6 mm and four sites with clinical attachment loss ≥ 5 mm, distributed in at least two different quadrants (Koromantzos et al. 2012).
排除标准
- •They are not medically controlled for obesity and cardiovascular risk factors at the start of the study. For ethical reasons, patient inclusion must be delayed at least 3 months when begins a pharmacological treatment.
- •They had history of kidney disease with Cr>1.2, CKD-EPI< 70 mil/min, or proteinuria > 300 mg/24 hours or 0.3 mg/grCr in isolated sample.
- •They had history of chronic lung disease, or acute disease during the previous 3 months.
- •They had history of stroke during the previous 3 months, myocardial infarction or revascularization during the previous 6 months, or recent angor pectoris history.
- •They had history of known peripheral artery disease, or chronic heart failure.
- •They had surgical treatment during the previous 3 months.
- •They had any disease that conditions compliance along the study, such as alcoholism or psychiatric disorder.
- •They had a history of systemic antibiotic usage over the previous 3 months.
- •They had non-surgical periodontal treatment during the previous 6 months; or surgical periodontal treatment over the previous 12 months.
研究组 & 干预措施
Minimal Periodontal Treatment (MPT)
Once the hopeless teeth have been extracted, randomized patients will receive a periodontal prophylaxis, in the form of supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and, after the last session, placebo capsules (one every 24 h for three days).
干预措施: Supragingival Prophylaxis (Procedure)
Intensive Periodontal Treatment (IPT)
Once the hopeless teeth have been extracted, randomized patients will receive non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and after the last session, systemic antibiotics (azithromycin 500 mgrs, every 24 h for three days).
干预措施: Scaling and root planning (Procedure)
结局指标
主要结局
Change in C-reactive protein
时间窗: Baseline, 3 months and 6 months
Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months
次要结局
- Change in Plaque Index(Baseline, 3 months and 6 months)
- Change in Bleeding on Probing(Baseline, 3 months and 6 months)
- Change in the % of Glycated haemoglobin(Baseline, 3 months and 6 months)
- Change in Clinical Attachment Level(Baseline, 3 months and 6 months)
- Change in the presence of selected periodontal pathogens(Baseline, 3 months and 6 months)
- Change in the proportions of selected periodontal pathogens(Baseline, 3 months and 6 months)
- Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid(Baseline, 3 months and 6 months)
- Change in the total counts of selected periodontal pathogens(Baseline, 3 months and 6 months)
- Change in Probing Pocket Depth(Baseline, 3 months and 6 months)