Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
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
- Lobene Tooth Stain Index
研究概览
简要总结
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.
详细描述
The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.
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
- •Signed Informed Consent Form;
- •Male and female subjects, aged 18-70, inclusive;
- •Good general health and good oral health based on the opinion of the study investigator;
- •Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
- •A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
- •Available for the duration of the study;
- •Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
排除标准
- •Presence of orthodontic appliances/retainers involving scorable teeth;
- •Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
- •Tumor(s) of the soft or hard tissues of the oral cavity;
- •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;
- •Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
- •Concurrent participation in another clinical study;
- •Self-reported pregnancy and/or lactating women;
- •Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
- •History of allergies to oral care/personal care consumer products or their ingredients;
- •History of alcohol and/or drug abuse.
研究组 & 干预措施
Group 1
Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F)
Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush
干预措施: NaF (Drug)
Group 2
Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F)
Colgate Adult Extra Clean soft-bristle toothbrush
干预措施: Na MFP (Drug)
结局指标
主要结局
Lobene Tooth Stain Index
时间窗: Baseline, and 6-weeks
Each tooth will be scored separately using a 4 point area Stain Area (extent): (0) No stain detected 1. Stain covering up to one third (1/3) of the region 2. Stain covering \> 1/3 to 2/3 of the region 3. Stain covering \> 2/3 of the region Stain Intensity: (0) No stain 1. Light Stain - yellow to light brown or gray 2. Moderate stain - medium brown 3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:
次要结局
未报告次要终点