The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Gingivitis Scores
研究概览
简要总结
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control toothpaste
1450 ppm Fluoride toothpaste
干预措施: Control toothpaste (Drug)
Experimental toothpaste
1450 ppm sodium fluoride toothpaste with a zinc base
干预措施: Experimental toothpaste (Drug)
Active comparator
1450 ppm sodium fluoride/triclosan toothpaste
干预措施: Active Comparator (Drug)
结局指标
主要结局
Gingivitis Scores
时间窗: 6 months (from Baseline)
Gingivitis scale (Loe \& Silness Gingival Index) Units on a 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)
Dental Plaque Scores
时间窗: 6 months (from Baseline)
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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