Comparative Assessment of the action of a commercially available Panax ginseng extract containing mouthwash with that of a Chlorhexidine and Sodium Fluoride containing mouthwash against dental Plaque and Gingival bleeding - A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- self
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Plaque Index by Silness and Loe 1964
研究概览
简要总结
Dental caries and Periodontal diseases are the two mostcommon diseases of the mankind. Dental plaque is the common etiological factorfor both of these disease conditions. apart from mechanical plaque control,chemical plaque control through the use of mouth rinse may aid as a valuableadjunct in controlling and the pathogenic microbes in dental plaque whichcause these diseases. many chemical plaque controlling agents were in use, butwith significant side effects like staining of teeth, alteration of tasteperception, dental calculus build up, allergic reactions in the oral cavity,development of white patches etc. thus a natural and culturally acceptable,cost-effective chemical agents which has less or no side effects is desirablein this context. red ginseng is one such product which has proven systemicbenefits and has been used for various systemic diseases . this interventionstudy therefore aims to measure the benefits of red ginseng extract containingmouth rinse against gingivitis and gingival bleeding. chlorhexidine gluconateand sodium fluoride mouth rinses served as positive controls. 90 patientsare to be recruited with 30 patients in each of the 3 groups. 1st group wasgiven the red ginseng extract containing mouth rinse, 2nd group was givenChlorhexidine gluconate mouth rinse and 3rd group was given Sodium Fluoridemouth rinse. informed consent will be obtained from the patients beforerecruiting them for the study. outcome variables measured were Index values ofPlaque Index and gingival index at baseline, 2 weeks, 4 weeks and at 6 weeks.the test mouth rinse, red ginseng extract containing mouth rinse is expected tohave beneficial effects in reducing the disease process and thereby show areduction in the index values as compared tto the baseline value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •subjects with completely erupted permanent dentition.
排除标准
- •subjects with advanced oral diseases subjects with history of systemic diseases subjects with history of antibiotic usage in the last one month subjects with history of tobacco use subjects with history of alcohol intake subjects wearing fixed or removable orthodontic or prosthodontic appliances subjects with known history of hypersensitivity to red ginseng extract pr chlorhexidine or sodium fluoride subjects who are physically and mentally challenged.
结局指标
主要结局
Plaque Index by Silness and Loe 1964
时间窗: the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week
Gingival Index by Loe and Silness 1963
时间窗: the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week
次要结局
- subjective reduction in the bleeding of gums(the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week)