Clinical Study to Assess the Efficacy of Professional Tooth Whitening Maintenance System of a Colgate Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Tooth color assessment
研究概览
简要总结
Clinical study to assess the efficacy of professional tooth whitening maintenance system of a Colgate toothpaste containing 5% Hydrogen Peroxide with a stain-fighter mouthwash as compared to only the stainfighter mouthwash and a negative control toothpaste
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •permanent natural teeth (6-11) (22-27)
- •composite lobene =>1
- •Signed Informed Consent Form
- •Male and female subjects aged 18-70 years, inclusive
- •Good general health and good oral health based on the opinion of the study investigator
- •All maxillary anterior teeth (teeth #6 through #11) must be present;& mandibular anterior ( Teeth #22 through 27) must be present
- •Availability for the duration of the study
- •Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker
- •A minimum mean of 1.5 ≥ determined by the Interproximal Modified Lobene (IML) Stain Index
- •Demonstrate a tendency to form stain in anterior teeth/ Have high staining habits ( coffee/ wine/ tea drinker)
排除标准
- •allergies
- •Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer
- •Restorations on the tooth to be scored which may interfere with scoring procedures
- •Obvious signs of periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
- •Five or more carious lesions requiring immediate care
- •Concurrent participation in another clinical study
- •Self-reported pregnant and/or lactating women
- •History of allergies to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients
- •Have dentinal sensitivity
- •Taking medication within a year which could alters natural tooth color or appearance,
- •Have used Professional Whitening product within a year or had a dental prophylaxis ( professional dental cleaning) within 30 days prior to the start of the study
研究组 & 干预措施
Whitening Regimen
干预措施: whitening maintenance (Other)
Whitening MW
干预措施: whitening maintenance MW (Other)
Negative Control
干预措施: negative control (Other)
结局指标
主要结局
Tooth color assessment
时间窗: 8 weeks
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Interproximal Modified Lobene Stain Index
时间窗: 8 week
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Tooth color assessment
时间窗: Baseline
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Tooth color assessment
时间窗: 4 weeks
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master®(29 tabs)
Interproximal Modified Lobene Stain Index
时间窗: Baseline
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
Interproximal Modified Lobene Stain Index
时间窗: 4 week
Stain examination will be determined by the Interproximal Modified Lobene(IML) Stain Index
次要结局
未报告次要终点