NCT00758394已完成3 期
Clinical Study to Compare Dental Plaque Control
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
- 29
- 试验地点
- 1
- 主要终点
- Dental Plaque Index
研究概览
简要总结
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
详细描述
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
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 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers at least 18 - 53 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).
- •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 are currently affecting salivary function
- •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.
- •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 dentifrice ingredients.
- •History of allergy to arginine (amino acid)
- •History of allergy to bicarbonate
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
研究组 & 干预措施
Total + Whitening toothpaste - B
Active Comparator
Triclosan/fluoride toothpaste
干预措施: Triclosan/Fluoride (Drug)
Fluoride - A
Placebo Comparator
Fluoride only toothpaste
干预措施: Fluoride (Drug)
Triclosan/fluoride/Amino Acid - C
Experimental
toothpaste containing amino acid #1
干预措施: Triclosan/Fluoride (Drug)
Triclosan/fluoride/Cavistat -D
Experimental
toothpaste containing amino acid/bicarbonate
干预措施: Triclosan/Fluoride (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. 0 = No plaque; 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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