Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- Percentage of bacterial viability
研究概览
简要总结
This study aims to evaluate the in situ antibacterial activity of a mouthwash containing essential oils with and without alcohol on undisturbed de novo plaque-like biofilm (PL-biofilm) up to 7 h after its application.
An appliance was designed to hold six glass disks on the buccal sides of the lower teeth, allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5, and 7 h later. After a washout period, the same procedure will be repeated with a sterile water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital staining, samples will be analyzed using a confocal laser scanning microscope analysing their bacterial viability and thickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy adults.
- •Minimum of 24 permanent teeth.
- •No gingivitis (Community Periodontal Index score = 0).
- •No periodontitis (Community Periodontal Index score = 0).
- •Absence of untreated caries.
排除标准
- •Smoker or former smoker.
- •Presence of dental prostheses.
- •Presence of orthodontic devices.
- •Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
- •Presence of any systemic disease that could alter the production or composition of saliva.
研究组 & 干预措施
essential oils
a single mouthwash with 20 ml of essential oils for 30 seconds.
干预措施: essential oils (Drug)
essential oils without mouthwash
a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.
干预措施: essential oils without mouthwash (Drug)
sterile water
a single mouthwash with 20 ml of sterile water for 30 seconds.
干预措施: sterile water (Drug)
结局指标
主要结局
Percentage of bacterial viability
时间窗: 48 hours after the volunteer has started to wear the splints
次要结局
- thickness in microns(48 hours after the volunteer has started to wear the splints)
研究者
Inmaculada Tomas
Senior Lecturer
University of Santiago de Compostela