Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- change in mean dental plaque
研究概览
简要总结
The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.
详细描述
A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.
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)
盲法说明
Product Code: XX Brush twice daily (morning and evening) for at least 2 minutes each time Cover the entire length of bristles with toothpaste
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
- •Male and female subjects had to be between the ages of 18 and 70 (inclusive),
- •Subjects needed to be available for the duration (6 weeks) of the study,
- •Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
- •Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
- •Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
- •Subjects had to sign an Informed Consent form,
- •Subjects had to be in general good health and
- •Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.
排除标准
- •Medical condition which require pre-medication prior to dental visits/procedures,
- •The presence of partial removable dentures,
- •Subjects who had advanced periodontal disease (gum disease),
- •Five (5) or more decayed or untreated dental sites at screening (cavities),
- •Subjects with diseases of the soft or hard oral tissues,
- •Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
- •Dry mouth as a result of a medication or medical condition,
- •Use of drugs that can currently affect salivary flow,
- •Use of antibiotics one (1) month prior to or during this study,
- •Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
- •Chronic (>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),
- •Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,
- •Pregnant or breast-feeding women were excluded from the study,
- •Subjects who participated in any other clinical study in the month preceding this study,
- •Allergic to common dentifrice ingredients,
- •Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,
- •Immune compromised individuals (AIDS, immune suppressive drug therapy) and
- •History of infectious disease or other blood borne diseases (Hepatitis series, HIV).
研究组 & 干预措施
Experimental Toothbrush 1
- A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
干预措施: Electric Toothbrush (Device)
Experimental Toothbrush 1
- A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
干预措施: oral health care application (Other)
Experimental Toothbrush 2
- A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
干预措施: Electric Toothbrush (Device)
结局指标
主要结局
change in mean dental plaque
时间窗: 3 and 6 weeks of product use
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
change in mean gingivitis
时间窗: 3 and 6 weeks of product use
gingivitis measurement is served as secondary efficacy variable
次要结局
未报告次要终点