Evaluation of Toothbrush Bristles in Plaque Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change of Navy Plaque Index (Navy Pl) After One-time Brushing
研究概览
简要总结
The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals may be included in the study if they meet all of the following inclusion criteria:
- •Must have read, understood and signed an informed consent prior to being entered into the study
- •Must be 18 to 70 years of age, male or female
- •Have at least 20 natural or restored teeth
- •Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
- •Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study
- •Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
- •Agree to abstain from the use of any dental products other than those provided in the study
- •Agree to comply with the conditions and schedule of the study
排除标准
- •Individuals are not eligible for participation in this study if any of the following are noted:
- •Physical limitations or restrictions that might preclude normal tooth brushing
- •Evidence of gross oral pathology
- •Presence of severe gingivitis with 30 or more sites showing bleeding on probing
- •Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
- •Chronic disease with concomitant oral manifestations
- •Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
- •Currently using bleaching trays
- •Eating disorders
- •Recent history of substance abuse
- •Smoking >10 cigarettes/day
- •Participation in other clinical studies within 14 days of screening
结局指标
主要结局
Change of Navy Plaque Index (Navy Pl) After One-time Brushing
时间窗: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes
Change of Digitally Measured Interdental Plaque Area After One-time Brushing
时间窗: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.
次要结局
- Change of Navy Plaque Index (Navy PI) After 7-day Brushing(Pre-intervention at baseline and after 7- day brushing at baseline)
- Change of Digitally Measured Interdental Plaque Area After 7-day Brushing(Pre-intervention at baseline and after 7-day brushing at baseline)