Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal: A Randomized, Double Masked Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plaque index
研究概览
简要总结
The objective of this study was to evaluate the efficacy of three methods for removal of dental biofilm when compared to dental toothbrushing control. Twenty patients were diagnosed and randomized into four groups according to the method tested: 1) apple 2) Rolly Brush 3) chewing gum and 4) brushing control. Subjects were evaluated four times according to the method used. All were evaluated before performing any method and after using each of the four methods separately. The patient's evaluation interval was 24 hours between the use of the methods. In the first stage, they underwent a clinical examination in which the needs of supragingival scraping or definitive restorations and prophylaxis were detected. After this step, all methods of oral hygiene and the consumption of fibrous foods and chewing gum were suspended for twenty-four hours. In the second stage, with a minimum of twenty-four hours after the first, volunteers received approximately 10 ml of basic fucsin to perform a mouthwash. The dental examination was then carried out for measurement on each dental surface and the plaque index was recorded on each surface. In the latter, four evaluations were performed with at least a 24-hour interval until the patients used the four methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 26 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good periodontal health
- •Minimum of eight occlusal surfaces of premolars and molars hygienic
排除标准
- •Less than eight occlusal surfaces
- •Use of orthodontic appliance
- •Use of dental prosthesis
研究组 & 干预措施
Rolly Brush
Chew for 1 minute
干预措施: Comparison of dental biofilm removal. (Device)
Chewing gum
Chew for 1 minute
干预措施: Comparison of dental biofilm removal. (Device)
Apple
Chew for 1 minute
干预措施: Comparison of dental biofilm removal. (Device)
Brush
brush for 1 minute
干预措施: Comparison of dental biofilm removal. (Device)
结局指标
主要结局
Plaque index
时间窗: 3 months
Comparison of the Quigley-Hein plaque index between the following groups: rolly brush, chewing gum, a, apple, brush.
次要结局
未报告次要终点
研究者
Olga Flecha
Principal Investigator
Federal University of São Paulo
