Antimicrobial Effects of Aqueous Extracts of Cinnamon and Ginger in Comparison to Chlorhexidine Gluconate 0.2% on Oral Streptococcus Mutans
试验速览
- 阶段
- 3 期
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- viability count measurement
研究概览
简要总结
Chlorhexidine is the most potent chemotherapeutic agent against mutans streptococci and dental caries, however, the incidence of side effects such as teeth discoloration, staining of restorations, undesirable taste, discoloration of tongue, dryness and burning sensation in the mouth discourage patients to use this mouth wash. Natural products are now preferred by a large proportion of the population and have been reported to possess antimicrobial activity.These products have recently been shown to be a good alternative to synthetic chemical substances for caries prevention like Cinnamon and Ginger. The aim of this study is to compare the antimicrobial effects of aqueous extracts of cinnamon 20% and ginger 20% in comparison to chlorhexidine gluconate 0.2% on oral streptococcus mutans
详细描述
Sample Size Calculation The aim of this study is to compare the antimicrobial effects of aqueous extracts of cinnamon 20% and ginger 20% in comparison to chlorhexidine gluconate 0.2% on oral streptococcus mutans. 2 way with repeated measures analysis of variance will be performed to study the effect of different solutions at different times. Based on previous papers, a large effect size is expected (f=0.4). a minimum total sample size of 18 patients ( 6 in each group) will be sufficient with the power of 85% and a significance level of 5%. This number is to be increased to 21 to compensate for losses during follow up. The sample size was calculated using G*Power program (University of Dusseldorf, Dusseldorf, Germany). Recruitment Patient will be recruited from the outpatient clinic in the conservative department after explaining the benefits from the application of the interventions to their oral hygiene which is natural unlike other chemicals mouth rinses that has complications such as staining, and burning sensation; from which eligible patients will be recruited to fulfill the eligibility criteria.
Randomization:
Sequence generation:
Randomization will be computer generated using (www.randomization.com).
Allocation concealment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history. The volunteers will be asked to suspend their usual oral hygiene practice at the day of the experiment
排除标准
- •Volunteers that receives any antimicrobial agents during the last two weeks prior to study , wearing any fixed or removable prosthesis or orthodontic appliance will be excluded.
研究组 & 干预措施
Cinnamon
20% cinnamon will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving cinnamon 20%
干预措施: Cinnamon (Dietary Supplement)
Ginger
20% ginger will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving ginger 20%
干预措施: Ginger (Dietary Supplement)
Chlorhexidine
Chlorhexidine gluconate 0.2%,will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving chlorhexidine.
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
viability count measurement
时间窗: within two hours
The number of colonies will be expressed as colony-forming units multiplied by the dilution factor per milliliter of saliva (CFU/ml) and compared before and after rinsing
次要结局
未报告次要终点
研究者
Nadhel Ahmed Mukred Mohamed
Master candidate at Conservative department
Cairo University