Antimicrobial effect of guava leaf(psiduim guajava) and lotus seed(Nelumbo nucifera) extract in mouth rinse as an adjunct in the treatment of chronic gingivitis- A Randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- SELF
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Reduced microbial colony Forming unit (CFU) , plaque index , gingival index in guava leaf mouthwash group , lotus seed extract mouth wash group are expected
研究概览
简要总结
The study aims to evaluate the clinical efficacy of herbal extracts of Psidium guajava and Nelumbo nucifera in reducing dental plaque and gingival inflammation. The preparation begins with the extraction of bioactive compounds from dried guava leaves and lotus seeds using a hydroethanolic solvent. This extract is formulated into 0.5,0.10 ,0.15 ,0.2 concentrations. After MIC , concentration is standardised and mouth wash formulated with standardised concentration base , incorporating glycerin glycerol, propylene glycol , Tween 80 , menthol, and distilled water. After initial phase of periodontal therapy , participants will be randomly assigned to either the test group and control group. The intervention involves rinsing with 5ml of solution for 60 seconds twice daily for one month . Evaluation is based on primary outcomes including the plaque index, the gingival index measured at baseline, one month and three month. Secondary outcomes will involve microbial analysis to determine the reduction in colony-forming units in saliva.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy individuals Age ranging between 18 and 40 years Presence of minimum 24 functional teeth Presence of chronic generalized moderate to severe form of gingivitis Patients within the age group of 18 to 45 years.
排除标准
- •systemically compromised patients subjects with removable or fixed orthodontics appliance or prosthesis subjects who were prescribed antibiotics or inflammatory drugs in the past 3 months patient on high polyphenol diet.
结局指标
主要结局
Reduced microbial colony Forming unit (CFU) , plaque index , gingival index in guava leaf mouthwash group , lotus seed extract mouth wash group are expected
时间窗: At baseline , 4 weeks , 12 weeks
次要结局
- Reduced microbial colony Forming unit (CFU) in guava leaf and lotus seed group(At 1 months= and 3 month)
研究者
Dr Haritha M
Karpaga vinayaga institute of dental sciences