NCT00758290已完成3 期
Clinical Study to Evaluate Dental Plaque
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Dental Plaque Index
研究概览
简要总结
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
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
- 20 Years 至 51 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers at least 20 - 51 years of age
- •Good general health
- •Must sign informed consent form
- •Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
- •No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
排除标准
- •Subjects unable or unwilling to sign the informed consent form
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Moderate or advanced periodontal disease or heavy dental tartar (calculus)
- •5 or more decayed untreated dental sites at screening (cavities)
- •Other disease of the hard or soft oral tissues.
- •Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- •Use of medications that are currently affecting salivary function
- •Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1
- •Pregnant or nursing women
- •Participation in any other clinical study within 1 week prior to enrollment into this study
- •Use of tobacco products
- •Subjects who must receive dental treatment during the study dates
- •Current use of Antibiotics for any purpose
- •Presence of an orthodontic appliance which interferes with plaque scoring
- •History of allergy to common toothpaste ingredients
- •History of allergy to arginine (amino acid)
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
研究组 & 干预措施
A
Active Comparator
干预措施: Triclosan/Fluoride (Drug)
B
Experimental
干预措施: Fluoride/triclosan (Drug)
结局指标
主要结局
Dental Plaque Index
时间窗: 4 Day
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
次要结局
未报告次要终点
研究者
研究点 (1)
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