Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Organoleptic Oral Malodor Evaluations
研究概览
简要总结
This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Must be male or female 18 to 70 years of age
- •Must be in good general health
- •Must be in good oral health based on self-assessment
- •Must be available during the weeks of this study for all appointment time points
- •Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
- •Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
- •Must give written informed consent
- •No known history of allergy to personal care/consumer products or their ingredients
排除标准
- •Participation in any other oral clinical studies for the duration of this study
- •Full or partial (upper or lower) dentures
- •Pregnant or lactating (breast feeding)
- •Use of tobacco products
- •History of allergy to common toothpaste ingredients
- •Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- •Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)
研究组 & 干预措施
Group I
Brushing twice daily in the morning and evening with 2 minutes each time
干预措施: test product (Drug)
Group I
Brushing twice daily in the morning and evening with 2 minutes each time
干预措施: Control product (Drug)
Group II
Brushing twice daily in the morning and evening with 2 minutes each time
干预措施: test product (Drug)
Group II
Brushing twice daily in the morning and evening with 2 minutes each time
干预措施: Control product (Drug)
结局指标
主要结局
Organoleptic Oral Malodor Evaluations
时间窗: Oral malodor evaluations at baseline & 3 weeks
The measured levels of oral malodor will be expressed in organoleptic scales (1-9)
次要结局
未报告次要终点