Evaluation of antimicrobial, anti-inflammatory and astringent properties of Illicium Verum in oral cavity: A double blind RCT
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Gingival health and reduction in salivary microbial count
研究概览
简要总结
Dental disease prevention is commonly associatedwith a reduction of some gram positive and gram negative microorganism. Presentlyno such study is available regarding the in vivo effect of star anise.
The primary outcome measure used for this study willbe to determine anti-inflammatory property and astringent property by Loe andSilness Gingival Index and papillary bleeding index respectively. The indiceswill be measured at baseline, 14th day and after 28 days ofadministration of the mouthwash. Afterevaluating the findings in 28 days, they will be made to undergo completeultrasonic scaling.
Antimicrobial activity: Subjects will be madecomfortable and asked to rinse mouth with normal tap water. They will be askedto spit their saliva into the sterile plastic containers. About 3–4 ml of wholeunstimulated saliva will be collected over 2 min. All the saliva samples of participantswill be coded during the period of sample collection and processing. Thesamples collected will be handed over to the pathology laboratory for analysison the same day. In the laboratory, samples will be stored at room temperature(17°C–25°C) prior to the analysis.
All samples will be sonicated (Vibra Cell 400 W,Sonics & Materials Inc. – 5% amplitude, 9.9 s cycle, six pulses) anddiluted in a saline solution (100 and 1000 times). The diluted samples (5 ul) will then spread on blood agar. ThePetri dishes will be placed in an incubator (Jovan IG 150) with 10% CO2at 37°C for 48 hours. Subsequently, the dishes with blood agar will be placedin an aerobic incubator at 37°C, for an additional 24 hours. Total oralmicroorganism counts will be performed in blood agar. Bacterial colonies willbe enumerated and the number of viable bacteria reported as colony formingunits per ml (CFU/ml).
Thus,the aim of this study is to observe the antimicrobial activity of star anise against oral microorganism and to testthe efficacy of star anise as astringent and anti-inflammatory agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Fifteen healthy subjects between the age group of 18-35 years.
- •Subjects having all teeth and presenting no allergy were selected.
- •Free from systemic diseases.
- •Subjects having moderate gingival scores and fair plaque scores according to the plaque and gingival indices proposed by Silness and Loe and Loe and Silness, respectively.
- •All the index teeth should be completely erupted.
- •Should not have used mouthwashes for the last 1 month.
- •Currently non-smokers.
- •Subjects formally agreed with all study aspects and signed the consent form.
排除标准
- •Subjects who had been on medication in the last 6 months.
- •Suffering from any diseases which might affect the salivary flow.
- •History of antibiotic therapy in the previous 1 month till the start of the study.
结局指标
主要结局
Improvement in Gingival health and reduction in salivary microbial count
时间窗: 28 days
次要结局
- Improvement in gingival inflammation and microbial count(28 days)