COMPARATIVE EVALUATION OF ENDOCAN AND TNF-ALPHA LEVELS IN CHRONIC PERIODONTITIS PATIENTS WITH TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in systemically healthy Chronic Periodontitis subjects
研究概览
简要总结
Tumour Necrosis Factor alpha is an established pro inflammatory marker in periodontal disease. However
till date there have been no studies evaluating Endocan as a diagnostic and prognostic marker in
periodontitis with Type 2 diabetes mellitus. Endocan is expressed in the initial stages of periodontal inflammation and expected decreased after the non surgical periodontal therapy.
Thus it is hypothesized that Endocan levels will be increased in periodontitis subjects with Type2 diabetes mellitus . Based on this ,If the hypothesis works ,Endocan can be used as a potent prognostic marker and a novel chair side diagnostic assay in periodontal disease diagnosis especially in Type 2 Diabetics subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Minimum number of 15 teeth should be present.
- •2.Patients with Generalised Chronic periodontitis exhibiting Probing Pocket depth of more than or equal to 4mm with Clinical attachment level of more than or equal to 3mm in more than 30percent of diseased sites, According to the AAP 1999 World Workshop (Group I) 3.If more than five sites satisfy the criteria, sample sites were selected based on greater amount of gingival inflammation, probing pocket depth and clinical attachment level.
- •4.Chronic periodontitis patient with Type 2 diabetes mellitus exhibiting good and poor control.
- •According to American Diabetic Association(ADA) classification of glycaemic control- a) Subjects with HbA1c below 7% , as Type 2 diabetics with good control in one group(group II) b) Subjects with HbA1c more than 8% , as Type 2 diabetics with poor control in another group(group III).
排除标准
- •1.Patients with other systemic condition or diseases influencing the course of periodontal disease other than diabetes.
- •2.Patients with haemoglobinopathies, bleeding and clotting disorders that will influence HbA1c level.
- •3.History of periodontal treatment within the previous six months 4.Antimicrobial therapy immunosuppressants or lipid lowering drugs within the past 3months 5.Current Smokers who have smoked more than or equal to 100 cigarettes in their lifetime and currently smoke,Former smokers have smoked more than or equal to 100 cigarettes 6.Heavy alcoholics 7.Pregnancy and Lactation.
结局指标
主要结局
1.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in systemically healthy Chronic Periodontitis subjects
时间窗: At baseline and after 3months
2.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with well controlled diabetes mellitus (HbA1C less than 7).
时间窗: At baseline and after 3months
3.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with poorly controlled diabetes mellitus (HbA1C more than 8).
时间窗: At baseline and after 3months
次要结局
- 1.To compare the levels of Endocan and TNF-alpha between study groups.(2.To Correlate Endocan and TNF-alpha levels with the periodontal clinical parameters in all the groups before and after non-surgical periodontal therapy)