Effect of Periodontal Intervention on Oxidative Stress in Chronic Kidney Disease Patients suffering from Moderate to Severe Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD.
研究概览
简要总结
Chronic Periodontitis is an inflammatory disease that cause destruction of periodontal connective tissue , loss of periodontal attachment ,and resorption of alveolar bone. The interaction between the pathogen and host defensive capacity result in periodontal tissue breakdown. Chronic kidney disease(CKD) causes the gradual loss of kidney function over time. Neutrophils become the most common inflammatory cells gathering in periodontal tissue and gingival sulcus, and they are believed to be the preÂdominant source of ROS in periodontitis and leads to damage of Periodontal tissue by oxidising DNA, lipids and proteins. So CKD is a low grade inflammatory process and chronic inflammation can itself lead to increased oxidative stress in advanced renal disease Periodontitis has also been shown to increase oxidative stress. Literature has shown that treating oxidative stress improves Chronic Kidney Disease. In Independent studies it has also been documented that reduced oxidative stress has resolutory role on periodontitis. The effect of reduction in the oxidative stress by treating periodontal disease on CKD status has not been studied so far. The rationale of the present study is to evaluate role of periodontal therapy in Chronic Kidney Disease by improving Oxidative Stress. After a detailed clinical and blood examination the subjects with CKD and Periodontitis will be included as per inclusion and exclusion criteria GCF and serum samples will be obtained and appropriate periodontal intervention and comparison will be provided . Than compiled data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age range: 30-60 years Chronic Kidney Disease Patients suffering from moderate to severe periodontitis Non-smoking (former smokers were included if they had not smoked within 6 months of the study initiation) No periodontal therapy within previous 6 months.
- •Patients who give consent Patients with minimum 20 teeth.
排除标准
- •History of atherosclerosis involving the coronary cerebral or peripheral vascular systems Experiencing a cardiovascular event (myocardial infarction or stroke) or undergoing coronary angioplasty or peripheral intervention procedure between the Screening Visit and randomization Undergoing any cardiovascular surgery (valvular surgery) within 3 months of study participationPlanned revascularization or peripheral intervention procedure or other cardiovascular surgery New York Heart Association (NYHA) Class III or IV heart failure at study participation Patient of End stage renal disease (ESRD)/ patients on hemodialysis or peritoneal dialysis Patients chronically treated (i.e 2 week or more) with any medication that affect periodontal status (i.e antibiotics or non-steroidal anti-inflammatory drugs) or lipid peroxidation with clinically significant or unstable organic diseases or compromised healing potential (i.e. connective tissue disorders or bone metabolic diseases).
- •Pregnant women or lactating.
- •Patients affected by active infectious diseases Asthma Diabetes Immune-compromised or taking steroid medications.
结局指标
主要结局
Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD.
时间窗: Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD. | Renal Function will be assessed by ACR (Albumin Creatinine Ratio)
Renal Function will be assessed by ACR (Albumin Creatinine Ratio)
时间窗: Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD. | Renal Function will be assessed by ACR (Albumin Creatinine Ratio)
次要结局
- Clinical parameters-Probing Depth (PD) CAL (Clinical attachment Loss) Plaque index(PI) Gingival Index(GI).(Change in the level of Inflammatory stress markers after periodontal intervention)