Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tooth color
研究概览
简要总结
Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for four weeks. Sixty participants were selected in accordance with inclusion and exclusion criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2- Close up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual oral hygiene, three times per day during four weeks. Evaluators assessed tooth color (CIEL*a*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3 and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least six anterior teeth without restorations
- •Participants should have good general and oral health (no dental caries and periodontal disease)
排除标准
- •Tooth sensitivity
- •Any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure)
- •Participants following orthodontic treatment
研究组 & 干预措施
Whitening dentifrices
Two groups used whitening dentifrices, three times per day during four weeks
干预措施: whitening dentifrices (Other)
Placebo
One group used conventional dentifrice, three times per day during four weeks
干预措施: Placebo (Other)
结局指标
主要结局
Tooth color
时间窗: 4 weeks
Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.
Tooth sensitivity
时间窗: 4 weeks
The pain caused by dentin hypersensitivity was measured over a 4 weeks time frame. The investigators stimulated the cervical region of the teeth with a blast of air from a triple syringe and patients reported pain intensity in accordance to Visual Analogue Scale (0= no pain, 10= pain bad as can be).
次要结局
未报告次要终点
研究者
Camila Tirapelli
PhD
University of Sao Paulo