Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index
研究概览
简要总结
The purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.
详细描述
Plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. The primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing.
This is a single-blind, randomized controlled trial. Sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and after a one-time brushing with the assigned study device. A soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessors and the principal investigator will be blind to toothbrush device assignment. In order to maintain blinding and eliminate assessor bias, study team members instructing and observing participants in the use of the assigned toothbrushing device will not be outcomes assessors.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 5-17
- •In good general health
- •Fluent in English
- •Parent or guardian willing and able to provide written informed consent
- •Have 16 scorable teeth (non-crown/bridge/or full amalgams)
- •Have had a dental cleaning and exam in the past 24 months
排除标准
- •Advanced periodontal disease or severe gum disease
- •Mouth or teeth pain that prevents brushing in any areas
- •Intraoral piercings (tongue or lip) that cannot be removed
- •Non-controlled diabetes
- •Any autoimmune or infectious disease or any medical condition that would delay wound healing
- •Untreated visible cavities or untreated dental work
- •Oral or gum surgery in the previous 2 months
- •Take antibiotic premedication for dental procedures
- •Undergoing or require extensive dental or orthodontic treatment
- •Current smoker
- •Generalized recession over 1mm
结局指标
主要结局
Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index
时间窗: baseline,1 minute after brushing
Average Change from baseline plaque index after brushing with the automated mouthpiece-based brushing device versus a manual toothbrush. The Turesky Modification of the Quigley-Hein Plaque Index evaluates 6 areas per tooth and gives a score from 0-5 with 0 being no plaque and 5 being the highest amount of plaque and the average score for all sites was used for analysis.
次要结局
- Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush(baseline, 1 minute after brushing)
研究者
Diane M Daubert RDH, MS, PhD
Clinical Associate Professor: School of Dentistry
University of Washington