Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
研究概览
简要总结
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.
详细描述
The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Must be between ages 18 to 65 years inclusive
- •Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
- •Must give written informed consent
- •Be in good general health
- •Must discontinue oral hygiene for 24-hours after initial appointment
- •No known 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
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Advanced periodontal disease
- •5 or more decayed, untreated dental sites
- •Diseases of the soft or hard oral tissues
- •Orthodontic appliances
- •Abnormal salivary function
- •Use of drugs that can 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 (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff
- •Pregnant or breastfeeding
- •Participation in another clinical study in the month preceding this study
- •Allergic to common dentifrice ingredients
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- •History of allergic reaction to any anti-inflammatory agents
研究组 & 干预措施
Negative Control
Regular Toothpaste
干预措施: Negative Control (Regular Toothpaste) (Other)
Prototype
AN0128 Toothpaste
干预措施: Prototype (AN0128 Toothpaste) (Drug)
Positive Control
Standard anti-plaque and anti-bacterial toothpaste.
干预措施: Positive Control (anti-plaque/anti-bacterial toothpaste) (Other)
结局指标
主要结局
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
时间窗: Baseline (time zero), 24 hour time point
次要结局
未报告次要终点