Six-Week Clinical Evaluation of a Toothpaste in Tooth Whitening Via Extrinsic Stain Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in Extrinsic Tooth Stain (Total Stain Score)
研究概览
简要总结
This randomized, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Adult subjects were assessed at baseline and after 7, 14, 28, and 42 days of product use using the Macpherson Modification of the Lobene Stain Index. Oral soft and hard tissues and subject-reported sensory responses were also evaluated throughout the study.
详细描述
This single-site, randomized, examiner-blind, two-cell parallel clinical trial enrolled adult subjects with qualifying extrinsic tooth stain. Following baseline assessments, subjects were randomized to either a test whitening dentifrice or a marketed control dentifrice. Subjects brushed twice daily for two minutes with their assigned toothpaste and toothbrush for 42 days. Extrinsic stain on the labial surfaces of the 12 anterior teeth was evaluated at baseline and at Days 7, 14, 28, and 42 using the Macpherson Modification of the Lobene Stain Index, assessing stain intensity, stain area, and total stain scores. Safety was monitored via oral soft and hard tissue examinations and subject-reported sensory assessments. Treatment comparisons were performed using ANCOVA with baseline scores as covariates.
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
- Triple (Participant, 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
- 否
入选标准
- •Adults 18-65 years in good general health
- •Mean MLSI score ≥1.5 on labial surfaces of at least 8 of 12 anterior teeth
- •Adequate oral hygiene and willingness to comply with study requirements
- •Dental prophylaxis within past 18 months but not within past 3 months
- •Willing to refrain from other whitening or oral care products during the study
排除标准
- •Significant medical conditions or oral pathology affecting assessments
- •History of adverse reactions to oral hygiene products
- •Orthodontic appliances or restorations interfering with stain assessment
- •Moderate or advanced periodontitis
- •Recent bleaching or whitening treatments
- •Pregnant or nursing
研究组 & 干预措施
Test Toothpaste
Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use.
干预措施: Whitening Test Dentifrice (Code 826) (Other)
Sodium Fluoride Control Dentifrice
Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.
干预措施: Control dentifrice (Code 378) (Other)
结局指标
主要结局
Change in Extrinsic Tooth Stain (Total Stain Score)
时间窗: Baseline to Day 42
Mean change in total extrinsic stain score measured on the labial surfaces of the 12 anterior teeth using the Macpherson Modification of the Lobene Stain Index, combining stain intensity and stain area scores.
次要结局
- Change in Stain Intensity and Stain Area Scores(Baseline to Days 7, 14, 28, and 42)