NCT00966953已完成3 期
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
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
- Plaque Index
研究概览
简要总结
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day 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
- 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.
- •Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- •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
- •Medical condition which requires pre-medication prior to dental procedures/visits.
- •Medical condition which precludes eating/drinking for 12 hrs.
- •History of allergy to common dentifrice ingredients.
- •Subjects unable or unwilling to sign the informed consent form.
- •Moderate or advanced periodontal disease.
- •Two 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.
- •Current use of antibiotics.
- •Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
- •Pregnant or nursing women.
- •Participation in any other clinical study within 30 days 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.
- •Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
研究组 & 干预措施
Fluoride Toothpaste
Placebo Comparator
fluoride control
干预措施: Fluoride (Drug)
Total/Whitening
Active Comparator
positive control
干预措施: Triclosan/Fluoride toothpaste (Drug)
antibacterial plant extract 1
Experimental
Honokiol
干预措施: Fluoride (Drug)
antibacterial plant extract 2
Experimental
magnolol
干预措施: Fluoride (Drug)
antibacterial plant extract 2
Experimental
magnolol
干预措施: antibacterial plant extract (Other)
结局指标
主要结局
Plaque Index
时间窗: 8 weeks
Plaque score scale: 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
研究者
研究点 (1)
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