Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Change From Baseline in C-Reactive Protein Level at 6 Months
研究概览
简要总结
The purpose of this study is to determine whether scaling and root planing as a periodontal intervention helps in improving the overall health of patients suffering from coronary heart disease.
详细描述
This study is a randomized, outcome assessor blinded, parallel group, trial to evaluate the effect of non surgical periodontal treatment in the form of scaling and root planing on coronary heart disease patients. 70 clinically defined coronary heart disease (CHD) patients with mild to moderate periodontitis, were allocated into two groups- experimental and control, in a ratio of 1:1. Scaling and root planing was provided as the intervention to the experimental group. To the control group no periodontal intervention in any form was provided. The primary outcome assessed is the changes in C-reactive protein level at baseline and after 1, 3, and 6 months of periodontal intervention. The secondary outcomes assessed are lipid profile, white blood cells (WBC) profile, and blood pressure (systolic and diastolic) at baseline and after 1, 3, and 6 months of periodontal intervention. Periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), periodontal probing depth (PPD), and clinical attachment loss (CAL) is also assessed at baseline and after 6 months. All these parameters were also compared with their corresponding values in the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female > 35 yrs of age
- •Clinically diagnosed stable CHD cases
- •No other systemic disease
- •Non-smoker
- •Advanced chronic gingivitis and mild to moderate chronic periodontitis (≥ 4 teeth with probing depth ≤ 5 mm) and ≥ 14 teeth (excluding third molars)
- •No periodontal therapy in the last 12 months.
排除标准
- •Not fulfilling criteria of the defined CHD case
- •Present smoker
- •Pregnant or lactating females
- •Suffering from any other systemic disease like diabetes
- •Taking systemic antibiotic therapy in the last 3 months
- •Advanced chronic periodontitis (probing depth > 5mm) and <14 teeth (excluding third molars)
- •Received any periodontal therapy within last 12 months.
结局指标
主要结局
Change From Baseline in C-Reactive Protein Level at 6 Months
时间窗: Baseline and 6 months
Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.
次要结局
- Systolic Blood Pressure at 3 Months(3 months)
- Change From Baseline WBC Profile at 1 Month(Baseline and 1 month)
- Change From Baseline in C-Reactive Protein Level at 1 Month(Baseline and 1 month)
- Change From Baseline Periodontal Parameter- Gingival Index at 6 Months(Baseline and 6 months)
- Change From Baseline Periodontal Parameter- Plaque Index at 6 Months(Baseline and 6 months)
- Change From Baseline in C-Reactive Protein Level at 3 Month(Baseline and 3 months)
- Diastolic Blood Pressure at 3 Months(3 months)
- Change From Baseline in Lipid Profile at 6 Months.(Baseline and 6 months)
- Change From Baseline WBC Profile at 3 Months(Baseline and 3 months)
- Change From Baseline WBC Profile at 6 Months(Baseline and 6 months)
- Systolic Blood Pressure at 1 Month(1 month)
- Change From Baseline in Lipid Profile at 1 Month(Baseline and 1 month)
- Change From Baseline in Lipid Profile at 3 Months(Baseline and 3 months)
- Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months(Baseline and 6 months)
- Systolic Blood Pressure at 6 Months(6 months)
- Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months(Baseline and 6 months)
- Diastolic Blood Pressure at 1 Month(1 month)
- Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months(Baseline and 6 months)
- Diastolic Blood Pressure at 6 Months(6 months)
研究者
Dr DIVYA SINGH HADA
Post-graduate Student
Government College of Dentistry, Indore