Efficacy of Subgingival Irrigation and Powered Toothbrush as Home Care Maintenance Protocol in Type-2 Diabetic patients with Active Periodontal Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of clinical parameters in diabetic patients suffering from chronic periodontitis on home care maintenance regime comprising of twice daily sub-gingival home irrigation using 0.06% chlorhexidine gluconate along with powered toothbrushes vis a vis those on routine home care maintenance regime comprising of twice daily mouth rinsing with 0.12% chlorhexidine gluconate along with manual tooth brushes.
研究概览
简要总结
Diabetes and Periodontitis seems to interact in bidirectional manner.The increased prevalence and severity of periodontitis seen in diabetic patients,especially in patients with poor metabolic control,has led to designation of periodontal disease as sixth complication of diabetes.Both diabetes and periodontal disease are complicating and enhancing each other magnitude and severity.It is suggested that along with medications for diabetes,the control of active periodontal infection should be essential to achieve a long term control of diabetes mellitus.Presently the standard of care for periodontitis patients with diabetes is non surgical therapy followed by surgical therapy depending on severity of disease. However this particular group of patients because of systemic complications,more often than not ,are not recommeded for elective surgery on immediate basis.Presently there is no standard protocol on which these patients should be on put until they are fit deemed for surgery.It is established that antiplaque agents may help in controlling active periodontal disease.The present study hypothesis the use of subgingival home irrigation with 0.06% chlorhexidine gluconate along with powered toothbrush , twice daily as an adjunct after supragingival scaling in type-2 diabetic patients suffering from active periodontal disease shall help in maintaining active disease free state in diabetic patients as compared to diabetic subjects on routine home care comprising of chlorhexidine gluconate rinses (0.12%) combined with manual toothbrushing twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type 2 diabetic patients (HBA1c >7%) with generalized chronic periodontitis clinically diagnosed with the presence of pocket ≥5 mm and probing attachment loss of 4 mm or more in at least 2 different quadrants which bleed on probing .
- •2.Subjects who are on oral hypo-glycemic agents or insulin injections and diet in combination or separately.
- •They should be diabetic for >1 year, are on the same type and dose of diabetic medication for the past 6 months 3.Patients who are in good physical condition and do not have any major illness or serious medical condition or transmissible disease.
- •4.Patients willing to give informed consent.
排除标准
- •1.Patients with known history of allergies especially to CHX.
- •2.History of systemic antibiotic usage over the previous 4 months.
- •3.Pregnant or lactating women.
- •4.Non-surgical periodontal treatment within the past 6 months 5.Use of nonsteroidal anti-inflammatory drugs.
- •6.Use of immunosuppressive medications.
- •7.Subjects with intake of supplemental Ascorbic acid.
- •8.Subjects with history of prolonged drug use that interfere with coagulation system, e.g Coumarin derivatives.
- •9.History of severe cardiovascular, haematological, renal, hepatic and immunological disorders.
- •10.Patients who are smokers and alcoholics.
- •11.Patient not willing to give informed consent.
结局指标
主要结局
Evaluation of clinical parameters in diabetic patients suffering from chronic periodontitis on home care maintenance regime comprising of twice daily sub-gingival home irrigation using 0.06% chlorhexidine gluconate along with powered toothbrushes vis a vis those on routine home care maintenance regime comprising of twice daily mouth rinsing with 0.12% chlorhexidine gluconate along with manual tooth brushes.
时间窗: baseline | 1 month | 2 month | 4 month
次要结局
- 1. Comparative evaluation of glycemic control between the study groups.(2. Comparative evaluation of inflammatory markers between the study groups.)