The Effectiveness of Water Flossing Versus Regular Flossing for Oral Hygiene in Children Aged 10-15 Years: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Plaque Index (PI)
研究概览
简要总结
The goal of this Randomized Clinical Trial is to compare the effectiveness of water flossing versus regular flossing in reducing dental plaque in children aged 10-15 years. The main question is the water flossing equal or more effective than regular flossing. Each participant will use both interdental cleaning methods, water flossing and regular flossing, in two separate visits and the plaque Index (PI) will be recorded.
Regular Dental Floss Group: Unflavored, unwaxed regular dental floss (Oral-B, USA), or Water Flosser: Water flosser (Waterpik Cordless Plus Water Flosser, USA)
详细描述
Ethical Approval:
The study protocol was reviewed and approved by the Research Ethics Committee of the Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia. Written informed consent was obtained from all parents or legal guardians prior to participation, in accordance with the Declaration of Helsinki.
Study Design:
This study was designed as a randomized, controlled crossover clinical trial. Each participant used both interdental cleaning methods, water flossing and regular flossing, in two separate visits with a 14-day washout period between interventions to minimize carryover effects.
Study Setting:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria included children aged 10-15 years, medically fit and systemically healthy, with no active orthodontic treatment or space maintainer with no use of any type of dental floss within the previous 24 hours.
排除标准
- •Children with fewer than four posterior proximal contacts were excluded from the study
研究组 & 干预措施
Regular Dental Floss
Unflavored, unwaxed regular dental floss (Oral-B, USA)
干预措施: Unflavored, unwaxed regular dental floss (Oral-B, USA) (Device)
Regular Dental Floss
Unflavored, unwaxed regular dental floss (Oral-B, USA)
干预措施: Water flosser (Waterpik Cordless Plus Water Flosser, USA) (Device)
Water Flosser
Water flosser (Cordless Plus Water Flosser, USA)
干预措施: Unflavored, unwaxed regular dental floss (Oral-B, USA) (Device)
Water Flosser
Water flosser (Cordless Plus Water Flosser, USA)
干预措施: Water flosser (Waterpik Cordless Plus Water Flosser, USA) (Device)
结局指标
主要结局
Plaque Index (PI)
时间窗: 16 days, 1st visit followed by 14 days washout period then 2nd visit
to assess the Plaque Index (PI) using the criteria of Silness and Löe (1964).
次要结局
未报告次要终点
研究者
Shahad Abudawood
Assisstant Professor
King Abdulaziz University