Compare the Clinical Efficacy of Prototype Toothpastes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
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
- •Subject 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.
- •5 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 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.
- •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.
- •History of allergy to zinc.
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
研究组 & 干预措施
Fluoride control -A
Winterfresh Gel
干预措施: Fluoride (Drug)
Triclosan/Fluoride - B
Positive control (Total toothpaste)
干预措施: Triclosan, fluoride (Drug)
Triclosan/fluoride/metal salt- C
test toothpaste
干预措施: Metal salt (Other)
结局指标
主要结局
Plaque Index
时间窗: 6 weeks
Plaque Index score 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)
Gingivitis Index
时间窗: 6 Weeks
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
次要结局
未报告次要终点