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临床试验/CTRI/2018/02/011970
CTRI/2018/02/011970已完成不适用

Evaluation of periodontal status among patients with coronary heart disease- effect of scaling and root planing on their periodontal and cardiovascular (clinical and biochemical) status

Dr Divya Singh Hada1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年1月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
C-reactive protein, lipid profile, blood pressure, WBC count

研究概览

简要总结

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 CHD patients with periodontitis, were allocated into two groups- experimental and control. Scaling and root planing was provided as the intervention to the experimental group. The primary outcome are the changes in C-reactive level and systolic blood pressure at the end of 6 months. The secondary outcomes are blood pressure, pulse, respiratory rate, C-reactive protein, lipid profile, WBC profile at baseline, 1, 3, and 6 months. Periodontal parameters including PI, GI, BOP, PPD, and CAL is also assessed at baseline and 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
Random Number Table
盲法
Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Male/Female more than 35 yrs of age, clinically diagnosed stable CHD cases, including stable angina, non ST elevation myocardial infarction, ST elevation myocardial infarction, not suffering from any other systemic disease, non-smoker, more than 14 teeth (excluding third molars), with advanced chronic gingivitis and mild to moderate chronic periodontitis (more than or equal to 4 teeth with probing depth less than or equal to 5mm), not undergone any periodontal therapy in the last 12 months formed the basis of inclusion.

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, less than 14 teeth (excluding third molars), with advanced chronic periodontitis (probing depth > 5mm), received any periodontal therapy within last 12 months.

结局指标

主要结局

C-reactive protein, lipid profile, blood pressure, WBC count

时间窗: 6 months

次要结局

  • C reactive protein, WBC count, lipid profile, BP, periodontal parameters(Baseline, 01 month, 03 month)

研究者

发起方
Dr Divya Singh Hada
申办方类型
Other [self]

研究点 (1)

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