The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California
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
- Whole-Mouth Gingivitis Measurement
研究概览
简要总结
The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months 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
- •Potential subjects must meet all of the following criteria
- •Subjects, ages 18-70, inclusive
- •Availability for the six-month duration of the clinical research study
- •Good general health
- •Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
- •Signed Informed Consent Form
排除标准
- •Presence of orthodontic appliances
- •Presence of partial removable dentures
- •Tumor(s) of the soft or hard tissues of the oral cavity
- •Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
- •Five or more carious lesions requiring immediate restorative treatment
- •Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
- •Dental prophylaxis during the past two weeks prior to baseline examinations
- •History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
- •An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
- •History of alcohol and/or drug abuse
- •Self-reported pregnancy and/or lactating subjects.
研究组 & 干预措施
Group I
toothpaste brushing 2x daily morning & evening for 2 minutes
干预措施: Test (Drug)
Group I
toothpaste brushing 2x daily morning & evening for 2 minutes
干预措施: Control (Drug)
Group II
toothpaste brushing 2x daily morning & evening for 2 minutes
干预措施: Test (Drug)
Group II
toothpaste brushing 2x daily morning & evening for 2 minutes
干预措施: Control (Drug)
结局指标
主要结局
Whole-Mouth Gingivitis Measurement
时间窗: baseline, 3 months and 6 months
difference of reduction in gingival index
Whole-Mouth Dental Plaque Measurement
时间窗: baseline, 3 months and 6 months
difference of reduction in plaque index
次要结局
未报告次要终点