NCT00759031已完成3 期
Investigation of Dental Plaque and Gingival Index
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
- 19
- 试验地点
- 1
- 主要终点
- Gingival Margin Plaque Index
研究概览
简要总结
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
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
- Single (Participant)
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 20 natural uncrowned teeth (excluding 3rd molars) present
- •Give written informed consent
- •Be in good general health
- •Must discontinue oral hygiene for 24-hrs.after initial appointment.
- •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
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 currently 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, naproxyn)
- •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)
研究组 & 干预措施
A - Marketed fluoride toothpaste
Placebo Comparator
干预措施: Sodium Monofluorophosphate (Drug)
B -Triclosan/NaF/CoPolymer toothpaste
Active Comparator
干预措施: Triclosan/Fluoride/Copolymer (Drug)
结局指标
主要结局
Gingival Margin Plaque Index
时间窗: 1 day
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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