Effectiveness of shunti parpataka kwatha gandoosha in comparison with chlorhexidine ADS 0.2 percent mouthwash in plaque induced gingivitis in the age group of 18-60 years -an open label randomised non-inferirity trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Reduction in Turesky modification of Quigley -Hein Plaque index score in plaque-induced gingivitis stage 1,2,3.
研究概览
简要总结
Gingivitis is the most common form of gingival disease. It is characterized by inflammation of
the gum, spontaneous bleeding redness, and halitosis. Gingivitis is reversible, but if left
untreated it can progress into periodontitis. The most common cause of gingivitis is poor oral
hygiene leading to plaque formation on teeth. Sheetada is one among the dantamoolagatha
roga caused by vitiation of kapha and rakta exhibit the similar feature of gingivitis. Sheetada
chikitsa involves rakthamokshana, pralepana, nasyam, kavala, and gandusha. This study
explores the potential of traditional Ayurvedic practice against the conventional treatment
method. An open-label randomised controlled clinical trial with 38 participants satisfying
inclusion criteria will be selected from the OPD of Shalakyatantra Department of Govt.
Ayurveda College Kannur. They will be assigned to a trial group with Shunti parpataka kwatha
twice daily and a control group with chlorhexidine ADS 0.2 % twice daily. The outcome of the
study will be statistically analyzed based on the change in plaque index score
and gingival index score from the baseline on the 22nd day and in the follow-up on the 35th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with Plaque-induced gingivitis with stages 1,2,
- •Participants irrespective of gender within the age group of 18-60 years.
- •Participants with a minimum of twenty teeth in the oral cavity.
排除标准
- •Participants with smoking habits.
- •Participants have taken anticonvulsants immunosuppressants and calcium channel blockers in the past one month.
- •Participants have taken Antibiotics in the past one month.
- •Participants having uncontrolled diabetes (FBS greater than 110 mg percent and PPBS greater than 140 mg percent) Orthodontic and prosthetic appliances use.
- •Participants with cardiovascular diseases hemorrhagic disorders and leukemia.
- •Participants who are mentally compromised and bedridden.
- •Vit C deficiency.
- •Pregnancy and lactation.
结局指标
主要结局
Reduction in Turesky modification of Quigley -Hein Plaque index score in plaque-induced gingivitis stage 1,2,3.
时间窗: At baseline,22nd and | 35th day.
次要结局
- Reducing Silness & Loe Gingival index score in plaque induced gingivitis stage 1,2,3.(At baseline,22nd day & 35th day.)
研究者
Anisha Jayan
Government Ayurveda College,Kannur