NCT00759187已完成3 期
Evaluate Clinical Research From Commerical Oral Care Products
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
- 25
- 试验地点
- 1
- 主要终点
- Dental Plaque Index
研究概览
简要总结
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
详细描述
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
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 (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
- •Male or female volunteers 18-65 years of age
- •Good general health
- •Must sign informed consent form
- •Minimum of 20 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) requiring more than one visit of cleaning sessions
- •2 or more decayed untreated dental sites at screening.
- •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 can currently affect salivary flow.
- •Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
- •Pregnant or nursing women.
- •Participation in any other clinical study within 1 week prior to enrollment into this study.
- •Allergy to chlorhexidine
- •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.
- •History of allergy to common dentifrice ingredients.
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
研究组 & 干预措施
A
Placebo Comparator
干预措施: Fluoride (Drug)
B
Active Comparator
干预措施: Triclosan/Fluoride (Drug)
C
Active Comparator
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Dental Plaque Index
时间窗: 4-Day
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
次要结局
未报告次要终点
研究者
研究点 (1)
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