Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
研究概览
简要总结
The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.
详细描述
Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.
Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.
Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.
The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.
The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30 % of sites with bleeding on probing.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosis of marginal periodontitis
- •No history of periodontal treatment
- •At least 14 natural teeth present
- •Dyslipidemia
- •And at least one of the following factors:
- •smoking, hypertension
排除标准
- •Rheumatoid arthritis
- •Any type of cancer in the previous 2 years
- •Pregnancy and lactation
- •Indication of the use of antibiotic for invasive procedures
- •Use of antibiotics in previous three months.
结局指标
主要结局
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
时间窗: 0, 3, 6, 9 and 12 months after therapy
次要结局
- Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level(0, 3, 6, 9 and 12 months after therapy)
