A Clinical Study to Evaluate the Stain Reduction Efficacy of a Non-Fluoride Tooth Whitening Dentifrice Containing Nano-Hydroxyapatite (nHAp) and a High Cleaning Silica Abrasive System Compared to a Commercial Fluoride Non-Whitening Dentifrice as a Negative Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- WHITENING
研究概览
简要总结
To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
详细描述
To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •2) Age Aged at least 18 years.
- •3) Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •4) General Health Good general health with no clinically significant and relevant abnormalities of medical history or dental examination in the opinion of the investigator or dental assessor.
- •5) Dental Details
- •Good oral health with 16 natural teeth including 11 of the 12 anterior teeth.
- •All facial surfaces gradable with no large restorations as judged by the investigator or dental assessor.
排除标准
- •Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •2) Breast-feeding Women who are breast-feeding.
- •3) Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •4) Clinical Study/Experimental Medication
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Previous participation in this study.
研究组 & 干预措施
Toothpaste
Toothpaste with stain removing abilities. Toothpaste contains an abrasive system that provides increased stain removal capabilities. Product will be used by teh subject at home with a toothbrush. Instructions provided for daily use of the paste with the brush. Example brushing for two minutes per occasion.
干预措施: toothpaste (Other)
Paste Dentifrice
Toothpaste with No stain removing abilities. The abrasive system used in teh placebo, though having cleaning properties, will not have teh ability to remove excessive stain.
干预措施: toothpaste (Other)
结局指标
主要结局
WHITENING
时间窗: 2 WEEKS
To determine whether brushing with a whitening dentifrice containing a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces than brushing with a commercial fluoride non-whitening dentifrice as a negative control for 2 weeks.
TOOTH COLOR
时间窗: 2 WEEKS
TOOTH WHITENING AND ORAL OIFT TISSUE INTEGRITY To determine the oral soft tissue (OST) tolerance of the dentifrices. To compare the change from baseline in stain levels as represented by the MLSI scores for overall, gingival, interproximal and body areas of the facial and lingual surfaces for each dentifrice after 2 weeks of product use.
次要结局
未报告次要终点