Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Turesky modification of the Quigley and Hein Plaque Index
研究概览
简要总结
The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.
详细描述
Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis stage 3
- •Completion of active periodontal treatment
- •Maximum probing pocket depths of 5 mm
- •No site ≥ 4 mm with bleeding on probing
- •Bleeding on probing < 10%
- •Open interproximal spaces both, in mandible and maxilla
- •Presence of > 23 natural teeth with no need for prosthetic rehabilitation.
排除标准
- •Oral or systemic diseases other than Periodontitis
- •Mucosal / periodontal swelling or Suppuration
- •Pregnancy
- •Need for frequent drug consumption
研究组 & 干预措施
waist-shaped interdental brush
waist-shaped interdental brush, use four times per interdental space
干预措施: waist-shaped interdental brush (Device)
cylindric interdental brush
cylindric interdental brush, use four times per interdental space
干预措施: cylindric interdental brush (Device)
结局指标
主要结局
Turesky modification of the Quigley and Hein Plaque Index
时间窗: 11 weeks
This is a plaque index scored as 0 = no plaque; 1 = slight flecks of plaque at the cervical margin of the tooth; 2 = a thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3 = a band of plaque wider than 1 mm but covering \< 1/3 of the crown of the tooth; 4 = plaque covering at least 1/3 but \< 2/3 of the crown of the tooth or 5 = plaque covering 2/3 or more of the crown of the tooth. A higher grade is worse (more plaque) than a lower grade. After measuring plaque grades on four sites per tooh, the mode is calculated, which is defined as the plaque grade most often measured in an individual.
次要结局
- papillary bleeding index by Saxer and Mühlemann(11 weeks)