Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Measurement of the dental plaque index
研究概览
简要总结
The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children attending school aged between 8 and 15 years
- •OR adults aged from 18 to 45 years
- •OR elderly persons aged more than 65 years old
- •Presenting at least one incisive, one canine, one premolar and one molar in each quadrant
- •Able to brush their own teeth at least twice a day
- •Persons who have provided written informed consent
- •Persons covered by the national health insurance agency
排除标准
- •Persons with acute periodontal disease
- •Persons in a period of postsurgical healing
- •Persons with an acute oral pain syndrome
- •Persons undergoing orthodontic treatment with a fixed brace
- •Persons not covered by the national health insurance agency
- •Pregnant women
- •The use of adjuvants
研究组 & 干预措施
Children
干预措施: Manual toothbrush Broscyl® (Device)
Children
干预措施: Manual toothbrush reference (Device)
Children
干预措施: Measure of the dental plaque (Procedure)
Adults
干预措施: Manual toothbrush reference (Device)
Adults
干预措施: Measure of the dental plaque (Procedure)
Adults
干预措施: Manual toothbrush Broscyl® (Device)
Elderly people
干预措施: Manual toothbrush reference (Device)
Elderly people
干预措施: Measure of the dental plaque (Procedure)
Elderly people
干预措施: Manual toothbrush Broscyl® (Device)
结局指标
主要结局
Measurement of the dental plaque index
时间窗: up to 3 months
次要结局
- Patient satisfaction(up to 3 months)