A Randomised Controlled Clinical Trial on the Use of a Dental Aerosol Box to Prevent Microbial Transmission During Dental Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total bacterial count
研究概览
简要总结
The study compares the use of a dental aerosol box in preventing microbial transmission during dental procedure. Subjects requiring scaling treatment (BPE 2) will be recruited. Subjects will be allocated either into the control group (conventional suction method) or interventional group (dental aerosol box) Treatment will involve scaling of two quadrants, where data collection of the microbes will be taken. Secondary outcome will involve a self-administered questionnaire on patients acceptance over the scaling procedure either with conventional suction or using the dental aerosol box to contain the aerosol generated during the scaling procedure.
详细描述
A closed operation room, with the facility to fumigate the room is chosen for all treatment procedures. Patients would be treated with time separations that would be reasonable to prevent microbial detection of the previous patient.
Sample size calculated based on Sadun et al (2020) to compare two groups would require 15 subjects per group for a 90% power and 0.05 significance.
Inclusion criteria: BPE 2 on at least 2 quadrants. Exclusion criteria: Smoker and systemic disease.
Patients will be randomised using randomiser.org. The list will be placed in a sealed envelop by an individual not involved in subject recruitment. Patient grouping will be determined after recruitment and consent. The envelop will be opened and patient allocated to the group.
Interventional group:
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
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BPE score of 2
排除标准
- •BPE score of 1, 3 or 4
- •Systemic disease
结局指标
主要结局
Total bacterial count
时间窗: 30 mins
The index of microbial air contamination is based on the count of the microbial fallout on to Petri dishes left open to the air according to the 1/1/1 scheme (for 1h, 1m from the floor, at least 1m away from walls or any obstacle). This index corresponds to the values of CFU calculated from the culture plates of 9 cm diameter. The index of microbial air contamination will be assessed at rest (before the beginning of dental procedures) and in operational of procedures (during procedures) to determine changes in bacterial count due to dental treatment.
次要结局
- Patient acceptance of dental procedure(1 treatment session, which is about 30 mins)
研究者
Dr Wan Nurazreena Wan Hassan
Associate Professor
University of Malaya