Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
详细描述
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be aged 18 to 65 years inclusive
- •Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- •Give written informed consent
- •Be in good general health
- •No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
- •If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
排除标准
- •Medical condition which requires pre-medication (antibiotics) prior to dental
- •Visits/procedures
- •Allergy to chlorhexidine
- •Advanced periodontal disease (gum disease)
- •5 or more decayed, untreated dental sites (cavities)
- •Diseases of the soft or hard oral tissues (gums or palate)
- •Orthodontic appliances that interfere with plaque rating
- •Abnormal salivary function
- •Use of drugs that can affect currently salivary flow or production
- •Use of antibiotics one (1) month prior to or during this study
- •Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
- •Pregnant or breastfeeding.
- •Participation in another research study in the month preceding this study
- •Allergic to common toothpaste or mouth rinse ingredients.
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
研究组 & 干预措施
Fluoride toothpaste
negative control toothpaste
干预措施: Fluoride (Drug)
Triclosan/Fluoride toothpaste
positive control toothpaste (Total toothpaste)
干预措施: Triclosan, fluoride (Drug)
Chlorhexidine Oral Rinse
positive control oral rinse
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Plaque Index
时间窗: 4 Days
Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
次要结局
未报告次要终点