Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Bacterial viability
研究概览
简要总结
The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.
详细描述
- To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
- Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
- Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy
- •good oral health status
排除标准
- •smoker or former smoker,
- •presence of dental prostheses or 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
结局指标
主要结局
Bacterial viability
时间窗: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity
It will be measured by analysis of images taken by Confocal laser Scanning Microscope
Bacterial diversity
时间窗: Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity
It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.
次要结局
- Biofilm thickness(Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity)
研究者
Inmaculada Tomas
Senior Lecture
University of Santiago de Compostela