Effect of non-surgical periodontal therapy on galectin-3 and tumor necrosis factor–α levels in gingival crevicular fluid of periodontitis patients with and without type 2 diabetes mellitus - A clinico-biochemical study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Galectin-3 and TNF alpha levels in GCF
研究概览
简要总结
This study is a non randomized , parallel group trial showing the effect of Non surgical periodontal therapy on the levels of Galectin-3 and Tumor necrosis factor alpha in GCF of periodontitis patients with and without type 2 diabetes mellitus . It will be conducted in The Oxford Dental College , Bangalore in India and the duration for the completion of study will be 3 months. The primary outcome measure will be Galectin-3 and TNF alpha levels before and after NSPT following 3 months. The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss before and after NSPT following 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Subjects of either gender, between the ages of 20 and 60 years.
- •Presence of at least 20 natural teeth.
- •Healthy subjects with clinical parameters of bleeding on probing less than 10 % and probing depth less than or equal to 3 mm iii.
- •Patients with diagnosis of generalised stage III grade B periodontitis with clinical parameters of probing depth more than or equal to 6 mm and clinical attachment loss more than or equal to 5 mm b) Subjects with type 2 diabetes mellitus ( HbA1c more than or equal to 6.4 % but less than 7 % ).
排除标准
- •a) Individuals with systemic diseases other than T2DM b) Obese individuals, BMI more than 25 kg/m2 c) Smokers d) Pregnant/Lactating and postmenopausal women e) Individuals who have received periodontal therapy in the last 6 months f) Individuals who have had a history of antimicrobial and anti-inflammatory therapy in last 6 months.
结局指标
主要结局
Galectin-3 and TNF alpha levels in GCF
时间窗: 3 months
次要结局
- Clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss(3 months)
研究者
Dr Divya Shonima
The Oxford Dental College, Bangalore