A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.
详细描述
The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.
Study design: randomised, single blinded, parallel.
After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.
The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.
At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good overall health
- •At least 20 teeth present, not including 3rd Molars
排除标准
- •Poor manual dexterity or mentally handicap;
- •Presence of removable intra-oral prosthesis
- •Current orthodontic therapy
- •Severe Periodontal condition or caries teeth in need of immediate attention
- •Pregnant women
- •Subjects that use medications that may effect oral health
- •No Systemic diseases/conditions such as diabetes mellitus, heart disease.
- •Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study
研究组 & 干预措施
Manual Toothbrush
Patients will be asked to use a manual toothbrush for 30 days
干预措施: Oral B Healthy Clean Manual Toothbrush (Device)
Sonic Toothbrush
Patients will be asked to use a sonic toothbrush for 30 days
干预措施: BURST Sonic Oral Care (Device)
Pulsating Toothbrush
Patients will be asked to use a pulsating toothbrush for 30 days
干预措施: Philipps Sonicare DiamondClean 300 Series (Device)
结局指标
主要结局
Plaque Index
时间窗: Baseline, 1 month
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Gingival Index
时间窗: Baseline, 1 month
gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
次要结局
未报告次要终点
研究者
Joan PiAnfruns, DMD
Assistant Clinical Professor
University of California, Los Angeles