Evaluation of mouthrinse containing guava leaf extract as a part of comprehensive oral care regimen - A randomized placebo controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The anti microbial and anti oxidant effect of guava leaf extract based mouth rinse will be evaluated by assessing saliva and plaque samples and improvement in the clinical parameters.
研究概览
简要总结
.
study hypothesis- To test the efficacy of a herbal based(guava leaf extract) mouthrinse to standard oral hygiene regimen for maintenance of oral health of patients with moderate to severe gingivitis
A total of 50 systemically healthy patients diagnosed with the chronic generalized gum infection will be included. The patient will be examined at first visit and will have to visit the same dentist after one, the second and third month from the commencement of the study. At each visit, the patient will undergo a complete oral examination. Also saliva and plaque samples will be collected for the biochemical and microbiological analysis. The participants will be asked regarding any side effects observed with the use of the mouth rinses during the follow-up visits. In this study, all the patients will receive thorough oral prophylaxis after which they will be randomly allotted to the 3 groups, which are the test group (guava leaf extract mouthwash), placebo group (distilled water) and the control group ( 0.2% chlorhexidine rinses).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Presense of a minimum of 20 functional teeth.
- •Patients with chronic generalized marginal gingivitis.
- •Patients within the age group of 18-50 years.
排除标准
- •Subjects with removable or fixed orthodontic appliances or prosthesis.
- •Subjects who have been prescribed antibiotics or anti-inflammatory drugs in the prior 3 months that might interfere with the plaque formation.
- •Subjects who have undergone periodontal treatment in the previous 6 months
- •Subjects who consume a high polyphenol diet (including green tea or soya diet) or known allergic.
- •Subjects who have a tobacco related habit
- •Pregnant and lactating women.
结局指标
主要结局
The anti microbial and anti oxidant effect of guava leaf extract based mouth rinse will be evaluated by assessing saliva and plaque samples and improvement in the clinical parameters.
时间窗: recall intervals of 1 ,2 and 3rd month.
次要结局
- Gingival index(Plaque index)