A Randomized Single-center, Double-blind, Two-cell Parallel-group Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Oral Malodor 12 Hours Post-brushing Overnight After 3 Weeks of Twice a Day (Morning and Evening) Product Use.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Organoleptic scores for each treatment group
研究概览
简要总结
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female adults between the ages of 18-70 (inclusive)
- •Subjects must be in general good health
- •Subjects must be in good oral health based on self-assessment
- •Subjects must be available for the duration of the study for all time point assessments
- •Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars)
- •Subjects were required to sign an Informed Consent form
- •No known history or allergies to personal care/consumer products or their ingredients.
排除标准
- •Participated in any other oral clinical studies during the duration of this study
- •Had full or partial (upper or lower) dentures
- •Women who are pregnant or lactating (breast feeding)
- •Use of tobacco products, (5) History of allergies to common mouthwash ingredients
- •Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods
- •Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy
- •Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).
研究组 & 干预措施
Test 1 toothpaste
干预措施: 0.454% stannous fluoride (Drug)
Test 2 Toothpaste
干预措施: 0.76% sodium monofluorophosphate (Drug)
结局指标
主要结局
Mean Organoleptic scores for each treatment group
时间窗: Baseline, 12 hours post brushing and 3 weeks
For each subject at each evaluation time point, the hedonic breath-odor scores assigned by the four (4) judges were averaged to yield a single subject-wise score. Statistical analyses were performed on these average organoleptic hedonic scores.
次要结局
未报告次要终点