Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.
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
- Composite Lobene Stain Index
研究概览
简要总结
The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form
- •Good general health
- •Male and female subjects, aged 21-70, inclusive
- •Present 12 scoreable natural anterior teeth
- •A minimum mean Composite Lobene Index score of 1 or greater
- •Available for the duration of the study
- •Clinical evidence of a tendency to form extrinsic stain on anterior teeth
排除标准
- •Presence of orthodontic bands
- •Presence of partial removable dentures
- •Tumor(s) of the soft or hard tissues of the oral cavity
- •Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
- •Five or more carious lesions requiring immediate restorative treatment
- •Use of antibiotics or stain inducing medications any time during the one month 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
- •Self-reported pregnancy and/or women who are breast feeding
- •Dental prophylaxis received in the past four weeks prior to baseline examinations
- •History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
- •On any prescription medicines that might interfere with the study outcome
- •History of alcohol and/or drug abuse
- •Exposed to a tooth whitening procedure during the last 3 months
研究组 & 干预措施
Group I
Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
Group I
Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
干预措施: Colgate Fluoride Toothpaste (CDC) (Drug)
Group II
Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
Group II
Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
干预措施: Colgate Fluoride Toothpaste (CDC) (Drug)
结局指标
主要结局
Composite Lobene Stain Index
时间窗: measurement at baseline, 3 week & 6 week
subjects will be evaluated for tooth stain by the dental examiner
次要结局
未报告次要终点