Efficacy of Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetic Patients With Periodontitis-A Split Mouth Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Bio-marker (Ghrelin) levels in Gingival crevicular fluid.
研究概览
简要总结
With the increase in the incidence of diabetes and obesity, among other artificial sweeteners the need of natural non-caloric sweetener with acceptable taste and without any adverse effects is demanding.So,the use of stevia presents beneficial effects to general and oral health and its properties could result potentially effective in the treatment of periodontal diseases.
详细描述
Stevia is considered as a novel molecule, because it is 100% natural and non caloric sweetener, with more sweetness than sucrose, without any adverse effects. It also demonstrates multiple benefits like anti-plaque effect, anti-diabetic effect, anti-periodontophatics properties, anti-hypertensive properties, anti-cariogenic properties etc. There are many studies conducted on stevia in humans, which justifies my study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Both stevia gel and placebo syringes are masked from participants and investigators.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that will be included in the study are in the age group ranging from 20-70 years -with established diabetes and under medication to maintain normal glycemic state i.e;Hb1Ac < 7％.
- •Oral findings including the presence of minimum of 16 natural teeth with minimum of 4 nonadjacent sites showing pocket depths≥ 5 mm.
排除标准
- •Subjects will be excluded from the study if they are using
- •any type of mouth-rinses or if they had underwent any periodontal therapy within the 3-months of the study or
- •if they were under antibiotics within the 3-months of the study.
研究组 & 干预措施
stevia rebaudiana bertoni
Randomly in all subjects one quadrant will be allotted as test site for placing stevia gel in the gingival sulcus having probing depth ≥ 5mm after performing thorough scaling and root planing.
干预措施: stevia rebaudiana bertoni (Drug)
placebo
Other quadrant will be allotted as a control site for placing placebo in the gingival sulcus having PD≥ 5mm after performing thorough scaling and root planing.
干预措施: placebo (Other)
结局指标
主要结局
Bio-marker (Ghrelin) levels in Gingival crevicular fluid.
时间窗: From baseline to 6-months.
GCF samples can be eluted from the strips by placing them in Eppendrof® tubes that contained 500 micro-litre of buffer and will be stored at -80℃ until analysis was done. The levels of GCF Ghrelin will be evaluated by using commercially available ELISA kit.
次要结局
- Probing depth(From baseline to 6-months.)
研究者
Dr R Viswa Chandra
Principal Investigator
SVS Institute of Dental Sciences