CTRI/2021/06/033985已完成不适用
Effect of Non Surgical Periodontal therapy in patients with Periodontitis and Type 2 Diabetes Mellitus
Haldia Institute of dental sciences and research1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年7月6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
- 180
- 试验地点
- 1
- 主要终点
- changes in clinical periodontal status, salivary biomakers level and markers of diabetes control
研究概览
简要总结
this will be a single centre,parallel arm , investigator masked clinical trial in type 2 diabetes mellitus patients with periodontitis .aim of the study is to evaluate role of periodontal treatment on gylcaemic control.clinical periodontal parameter ,salivary biomarker and HBA1c are the variables to measure the treatment outcomes.this will be 12 months follow up study .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Gingivitis : full mouth bleeding on probing less than 10% of sites.
- •Subjects with Periodontitis : Subjects with Periodontitis with interdental clinical attachment loss detectable at >- 2 non adjacent teeth .Buccal or oral clinical attachment loss >-3 mm with pocketing > 3mm is detectable at >-2 teeth.
- •Subjects with Periodontally Healthy (PH) : Subjects with PH will have no history of periodontitis, no sites with PD and CAL > 3 mm concurrently and no more than 10% of the sites with gingival bleeding and/or BoP.
- •Diabetic subjects :The diabetic subjects will require a diagnosis of DM confirmed by a physician, dating from at least 2 years prior to the study.
- •In addition, all diabetic patients will be required to have a HbA1c > 6.5% and FPG > 99 mg/dl.
- •Non-diabetics: Non-diabetic subjects will have no history of DM, HbA1c ≤ 6.0% and FPG < 99 mg/dl.
排除标准
- •Pregnancy; breastfeeding; subgingival periodontal therapy during the previous 12 months; use of antibiotic, anti-inflammatory, and/or immunosuppressive therapies during the previous 6 months; regular use of mouthrinses containing antimicrobials; use of orthodontic appliances; presence of other infectious, immunological, and/or inflammatory systemic conditions (e.g., immunological disorders, rheumatoid arthritis) and major complications of DM (i.e.,ulcers, gangrene, amputation, neuropathy, and nephropathy),smokers.
结局指标
主要结局
changes in clinical periodontal status, salivary biomakers level and markers of diabetes control
时间窗: at 3, 6 and 12 months after non surgical periodontal therapy.
次要结局
- Oral health behaviour and Quality of life assessment(3,6 and 12 months)
研究者
研究点 (1)
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